Date: March, 2023 | CategoryProofreading Author: Hana Trokic


In today’s digital world, we create large volumes of data in the form of files. These files could be print and text documents, graphic or artwork files, or even barcode or braille files.

All of these files are necessary for the development and production of several, if not all the products, that we use on a daily basis. Everything from the food we eat to the hygienic products we use has accompanying packaging, labels, and other documentation. 

As the number of products we manufacture and use grows, so does the amount of data and files created. With so many files to create and subsequently proofread and revise, it becomes extremely challenging to keep track of all the files and the changes made to them. 

This is where file comparison software comes in. But what is it exactly? 

This blog post will take a deep dive into what exactly file comparison software is and how it can help businesses streamline their content production and revision processes. 

An Overview of File Comparison Software 

In the simplest terms, file comparison software is a tool that allows users to compare two or more files and identify the differences between them. 

This software is designed to help users detect changes made to files as they move through revision cycles, ensure consistency, avoid errors, and overall simplify proofreading processes while increasing accuracy and efficiency. 

File comparison software inspects copy, content, and files of all kind and finds all discrepancies between the two. A simple digital inspection will reveal and pinpoint differences allowing adjustments and corrections to be made accordingly in a fraction of the time. 

Some of the main benefits of file comparison software include:

  • Saves time: Comparing files manually can be time-consuming and tedious. File comparison software automates the process and saves time.
  • Improves accuracy: File comparison software is more accurate than manual comparison, reducing the risk of errors.
  • Increases productivity: File comparison software allows users to focus on other tasks while the software compares files and finds discrepancies, increasing productivity.
  • Enhances collaboration: File comparison software makes it easy for multiple users to work on the same file and avoid conflicts. It also ensures cohesion and consistency in revisions. 

Ensure Error-Free Content With File Comparison Software

With digitalization becoming more prevalent in every aspect of our daily lives, businesses are taking note. They need to turn to technology and automation to stay afloat, keep up, and prevent falling behind market competitors.

Businesses need to make the best of the software available to ensure that they implement and use best practices in their workflows. This way, they will be able to streamline and optimize processes and stay profitable while thriving in today’s very competitive and globalized market. 

Innovative technology such as file comparison software allows businesses to proofread and check content, artwork, and copy with utmost precision. 

An optimal solution for your proofreading woes, the software will:

  • Eliminate errors, no matter how small 
  • Increase accuracy 
  • Increase production times 
  • Increase productivity and efficiency of workflows   

Overall, file comparison software allows for the absolute optimization of proofreading processes by tackling proofreading holistically and finding all discrepancies simultaneously instead of isolating individual errors. 

Built for Regulated Industries 

File comparison software is widely used in different industries, but has proven to be extremely beneficial for highly-regulated industries such as pharmaceuticals, print and package, consumer goods, and regulatory affairs.

These industries deal with extremely sensitive documentation and products and even minor content errors can have detrimental or irreversible consequences.

While even a small spelling mistake or formatting discrepancy may seem like a minor detail, these tiny errors may lead to severe consequences such as financial setbacks and a decrease in brand integrity and reputation. 

Quality control processes that heavily depend on manual checks are prone to errors and businesses that do not want to risk critical errors slipping through opt for technological solutions that help streamline their workflows and increase efficiency and accuracy. 

While content varies depending on the industry, file comparison software runs holistic scans of files, finding all discrepancies (no matter how small) between the two in seconds. What would manually take a minimum of hours to complete, innovative file inspection software completes in a fraction of the time. 

The software’s diverse capabilities enable regulatory industries to effortlessly and accurately maintain compliance of their labels across the asset life. Whether it’s text, graphics, barcodes, braille, print, or color, the software detects and corrects all errors, ensuring the accuracy and quality of content and critical assets. This provides companies with a sense of confidence, knowing that all errors are being identified, addressed, and amended.

Investing in automated proofreading software is a quick and straightforward way to ensure no errors are slipping through throughout the entire product creation and revision cycle and gives businesses complete confidence that they are sending error-free products out to market. 

With this innovative technology, not only will businesses improve the speed and accuracy of their quality control processes, but they will also be able to run holistic scans of any document in record time. Scans will yield a complete report of all differences found between the master and sample copy allowing you to make the necessary corrections for completely accurate files.

Endless Advantages For Regulated Industries

Globally, corporations are constantly looking for new ways to adapt to innovations and advancements in technology. They know that embracing the digital era is the key to keeping productivity high and staying profitable. This is especially true for regulated industries. 

For proofreading and quality control, automation is the only way to go.  

This technological advancement runs side-by-side comparisons of two files (the original and a sample file) to identify discrepancies. Instead of sifting and scanning through piles of documents manually, trying to find every mistake that might be hidden between the lines, the software does it for you in a fraction of the time. 

If you aren’t convinced, current file comparison software technology can compare documents at 1000 characters per second. Overall, not only will automated quality control solutions complete proofreading tasks faster, but it will also complete them with a higher degree of accuracy. 

For businesses to stay relevant in these challenging economic times and unpredictable markets, they have to make adjustments that will allow them to stay competitive. One way to do this is through digitalization and automation of workflows. Automated quality control, such as file comparison software, is the ultimate solution that allows businesses to stay up-to-date and competitive. 

The Solution is Automated Quality Control 

Thinking towards the future to ensure that workflows and processes are up to date is the only way businesses can withstand any market changes that come their way. 

File comparison software is an essential tool in today’s digital world that allows users to identify differences between files quickly, accurately, and efficiently. By using file comparison software, users can improve their productivity, reduce errors, and enhance collaboration.

The simple addition of file comparison software to a business’s work processes is a small step that will ultimately result in colossal advantages to company productivity and profitability. From ease of work to increased accuracy and optimization, introducing a file comparison tool into your everyday practices is a corporate no-brainer. 

Whether you are proofreading in the early or final stages of revision, you can make sure your products are 100% error-free when they go out to market with the precision and accuracy of file comparison technology.

Want to infinitely improve your proofreading processes and automate your quality control processes? Learn more about the benefits of file comparison software and request a demo of GlobalVision here.

Blog Post - Proofreading Made Easy: A Comprehensive Guide to File Comparison Software

Date: February, 2023 | CategoryProofreading Author: Hana Trokic


How can you ensure the content you are producing is consistently error-free?

Incorporating file comparison software into your proofreading and revision workflows is a good place to start. 

Most of us are all fully aware of the faults and consequential dangers that manual checks and revisions can bring to your brand and business. Not only are they time-consuming, tedious, and, above all error-prone, they do not provide manufacturers the confidence that they are producing truly error-free products and accompanying content. 

Through the innovative technology of file comparison software, quality assurance teams can now proofread, inspect, and revise files with complete ease and efficiency. In seconds, the software can run an inspection and detect even the most minor errors to ensure that your final documents and products are error-free and up to desired standards.

With the ever-increasing demand for quality and reliable products and content, it is important to have a robust proofreading process in place. Incorporating file comparison software is your first, and most crucial step, in building the most efficient and optimized quality control processes for your business. 

What is File Comparison Software?

Through its automated technology, file comparison software runs side-by-side comparisons of two files to identify discrepancies and errors in mere seconds. The software then generates a holistic report highlighting all the differences between the two files, allowing users to navigate through the report and correct their content effortlessly.

Eliminating several steps typically needed to create, proofread, and publish content, file comparison software simplifies, optimizes, and upgrades workflows while allowing for the creation of critical content at scale that is free from mistakes.

What Features Can File Comparison Software Inspect?

The software can be used to compare a range of different files and formats. Also, contrary to popular belief, the software is not limited to finding differences in just text. File comparison software inspects files holistically finding all differences present in the file.

File comparison software can inspect the following: 

Did a printer error cause text breaks in the headline of your brochure? Is your barcode missing a line? Did the positioning of your logo change when the graphic file was printed? All of these discrepancies will be detected by file comparison software, allowing you to make adequate edits and changes. 

Through the innovative technology of file comparison software, simply scan and inspect to find the most minor errors allowing for consistently pixel-perfect and accurate content.

What’s more, cloud-based proofreading software such as Verify, takes simplicity to the next level and allows you to conduct inspections completely online. No need for complicated applications or setups, this cloud-based tool simply requires a secure wifi connection to help you get your proofreading tasks done lightning-fast with laser precision.

Why is File Comparison Software Important for Proofreading?

Proofreading is a critical step in the content creation process, as it ensures that the final content is error-free and meets desired standards. By incorporating file comparison software into your proofreading process, businesses can quickly identify changes between various file versions at different stages of development and production.  

This ensures that even as files are being modified throughout the revision cycle, it is consistently being checked, inspected, and corrected. The final result is content and ultimately products that are accurate and virtually flawless. 

What’s more, the key to perfect proofreading is through the implementation of efficient revision and proofreading cycles, or in other words, to work smarter, not harder – an essential approach to improving performance in any business. Working smarter helps you increase focus and work more efficiently on your tasks and responsibilities. 

This form of optimization at the workplace can only be achieved if your business is continuously updating and improving its methods of work to keep up with current demands. 

One of the simplest ways to increase workplace optimization is to implement new technologies into your processes that enable you to get the job done faster, all the while maintaining accuracy and quality. 

File comparison software allows you to do just that by comparing a sample to an approved file and finding all errors before any content goes out to print and production. Not only does it speed up proofreading and revision cycles, but it also optimizes the entire content creation process as it makes editing content easier.

The best part? The software can be implemented in all stages of the workflow and ensures that you are creating truly error-free content before it goes out to market

The Benefits of File Comparison Software

One of the biggest advantages of incorporating a file comparison tool in your revision workflows is that it streamlines proofreading processes. What was once unimaginable through manual inspections is now very much a reality thanks to technological advancements in automated quality control.

No matter how small the errors or differences may be, the software will detect them, pinpoint their exact locations, and generate a comprehensive inspection report that will allow you to review and navigate through all found differences. 

The advanced and innovative technology increases the accuracy of content, increases the quality assurance team’s efficiency, and ultimately makes content and products better.  

Some benefits of using file comparison software include: 

  • Saves time: File comparison software saves time as it highlights differences, making it easier to review, correct, and approve them. This saves users from having to manually compare two files, which is tedious, extremely time-consuming, and prone to errors.
  • Increases accuracy: File comparison software increases accuracy as it highlights the changes between two files, reducing the chance of missing errors. This ensures that the final content is error-free and up to desired standards.
  • Enhances collaboration: File comparison software allows for easy collaboration between team members, making it easier for everyone to review changes and provide feedback. This ensures that everyone on your team is on the same page and that the final content is of the highest quality.
  • Easy to use: File comparison software is user-friendly and easy to use, making it accessible to all team members, regardless of their technical expertise.

What Industries can Benefit from File Comparison Software? 

Is your business producing any form of written or graphic content? Most likely, it is, in which case you can benefit from file comparison software.

Automated proofreading solutions were created with all content in mind but some industries are more sensitive to mistakes than others. 

The following industries can massively benefit from a file comparison tool: 

It is important to note that using software that will streamline proofreading processes in record time is essential for all businesses but proves to be a critical asset for highly-regulated industries that deal with sensitive documentation and content such as legal documents, pharmaceuticals, beauty products, food, and other consumer goods. 

These industries cannot afford the detrimental effects of even minor errors slipping through in their documentation, packaging, labels, and so on. In these cases, errors can lead to disastrous financial consequences and a complete deterioration of brand integrity and reputation.

File Comparison Software for Better Content

Content creation involves many different processes and workflows before it can be published and go out to market. Yet, to ensure the complete accuracy of every piece of content and artwork that makes it to market, modern businesses cannot rely on outdated and obsolete practices to ensure the quality of their content and products. 

Companies need to turn to more efficient and adequate solutions in order to modernize their workflows and keep up with market demands. File comparison software is the ideal solution for any and all businesses that want to stay competitive, streamline their workflows, and optimize their content flows to meet growing consumer demands. 

The benefits a file comparison tool will bring to your business are countless and in most cases, it is a crucial and important company resource, especially for those working in highly-regulated industries. The only way a business can be completely confident that its content and products are error-free is through fast, accurate, and trusted software. 

Ready to step into the world of automated proofreading? Request a demo of our innovative document comparison software or set up your free trial to see how this technology can revolutionize your everyday business practices. 

If you would like to try out our web-based proofreading software solution, Verify, start your free trial today, or contact us for more information.

Transform your quality control processes with GlobalVision.

RCount - The Next-Generation Automated Counting System

Date: February, 2023 | CategoryQuality Author: Hana Trokic


The next-generation automated counting system is here.

Built specifically for regulated industries, RCount by GlobalVision is the market-leading automated counting system and technology that ensures compliance and traceability of sensitive materials. Your teams can now count your critical assets with 100% accuracy in record time.  

This next generation in automated counting is a product of GlobalVision’s RVision department – one of our engineering departments focused on developing and innovating hardware solutions to solve long-standing industry challenges using the latest technologies available. 

The RCount is the next generation of our legacy system the “iCount” and brings new upgrades and capabilities that previously were not available. You can now confidently count larger batches of your cartons, inserts, leaflets, or vials with higher precision and efficiency. 

The latest upgrade of GlobalVision’s first-ever product, the RCount has been meticulously developed from the ground up with the purpose of helping regulated industries count their critical assets.

In the last 30 years, this automated counting system has been consistently and refined to ensure users always meet market and consumer demand, in record time, all the while enjoying a seamless end-user experience and state-of-the-art design and technology.  

The Benefits of Automated Counting Software 

To achieve complete confidence in the accuracy of their counts, reduce their margin of error, and ensure that their counting processes are streamlined and efficient, regulated industries need to turn to technology to keep up with growing consumer and market demands.

With increasing amounts of products being developed and produced, manually counting critical assets is simply not an option for industries that need to ensure the utmost quality and accuracy of their products. 

What’s more, highly regulated industries in particular have very little room for error and must ensure that final counts of their critical assets are accurate. Automated counting software like the RCount not only guarantees completely accurate counts but also ensures that final products and packages are completely compliant without any missing assets or documentation. 

The results are a more streamlined product development and production process and an overall more streamlined revision cycle for quality assurance teams in regulated industries.

Eliminate Errors Through Automated Counting Software 

RCount is a fully automated counting system that uses advanced technology to accurately count critical assets in record time. 

With 100% accuracy, teams can now use RCount to count batches of up to 700 items in mere seconds. Its predecessor, the iCount was only able to count batches of up to 350 items, which is a testament to the improvements and advancements of this next-generation automated counting system.        

The new RCount is camera-based, using a high-resolution camera with high-precision sensors to offer only the most accurate counts. The camera resolution on the RCount has increased from two to 20 megapixels and the lighting has been enhanced to a new LED. These enhancements result in a better, more intuitive design and provide more evenly distributed lighting over the counting region.

RCount can detect and count your critical assets with extreme ease, speed, and 100% accuracy. Currently, no other counter is available on the market, making this truly an authentic and innovative technology.

This state-of-the-art technology is designed to revolutionize the way regulated industries count their critical assets, particularly the following:

  • Carton counting 
  • Vial counting 
  • Leaflet counting 
  • Insert counting 

Technology That’s Easy to Use 

In addition to its efficiency and accuracy, the RCount automated counting system is also very easy to use. With a user-friendly and straightforward interface, teams in regulated industries can quickly install the system and start counting their critical assets almost immediately, improving workflows with little to no set-up or training downtime.

Regardless of industry, the RCount automated counting machine is sure to immensely improve quality control processes. Teams working in the following can particularly benefit from its state-of-the-art technology:

Optimize Your Counting Processes 

Scale tedious and time-consuming counting processes by leveraging the power of automated counting technology today. 

An automated counting system is a valuable asset for businesses in all regulated industries that deal with sensitive products that need to be counted with precision. With its advanced technology, RCount will help increase the efficiency, accuracy, and productivity of your quality control processes. 

Contact us to learn more about this innovative new product or request a personalized demo of RCount to see how it can specifically help your team prosper.

Date: February, 2023 | CategoryProofreading Author: Hana Trokic


Ready for a new, heightened Verify experience? 

Our first release of the year is here! Verify 2023.1 makes automated proofreading even more effortless than before. This new release boasts new features and capabilities that enhance the overall user and admin experience, ensuring complete ease of use while increasing the accuracy and efficiency of your quality inspections. 

Verify, Our Cloud-Based Proofreading Software

Verify is cloud-based proofreading reinvented that ensures error-free content with the utmost ease of use. With Verify’s automated proofreading platform, you can streamline your work processes and produce higher-quality content in record time.  

What to Expect From Our Latest Release 

Verify 2023.1 includes new advancements that will heighten ease of use, security, and accuracy. Verify 2023.1 Release Blog Post

The most impactful feature of this release is the introduction of SSO (Single Sign On), which enables users to securely authenticate with multiple applications by using just one set of credentials. The following SSO platforms will be supported: Azure, Okta, and Ping Federate. SSO also removes the overhead of managing the software, reduces security concerns, and minimizes the risk of implementing the software.

Additionally, this latest version broadens the capabilities of Text Inspection 2 and allows for smarter difference grouping which results in fewer false positives when reviewing results.

Verify 2023.1 Release Blog Post

Here’s what to look forward to with Verify 2023.1 

  • Single Sign-On for Improved Security
  • Enhanced Text Inspection 2 Functionality:
    • Text Select and Marquee Zones
    • Ignore Text Zones and Ignore Pages
    • Formatting differences including bold, italic, and underline
    • Less False Positives with Meaningful Difference Grouping

Who Can Benefit From This Release?

While Verify is built for regulatory affairs and promotional teams in all industries, Verify will prove to be especially beneficial for those working in the enterprise pharmaceutical, consumer packaged goods, as well as marketing, and advertising industries. 

Whether you work in a creative or more technical department, Verify 2023.1 is sure to heighten your proofreading and revision processes. Through ease of use, convenience, and simplicity, our all-encompassing comprehensive platform is a valuable tool for all professional teams. 

Heighten your Proofreading Experience

Our new capabilities were built with the end user in mind to ease their everyday proofreading and quality control processes. 

Whether you are saving time and increasing security through our Single Sign On feature or are enjoying fewer false positives and a more streamlined inspection process, Verify 2023.1 brings you an overall enhanced proofreading experience. 

If you are interested in a more personalized overview of Verify and how it can help your team specifically, request a demo here or take advantage of a free trial today.

Make the switch to automated quality control and discover how Verify can streamline your workflows and benefit your team’s overall quality control processes.

Banner Image - FDA Labeling Requirements Pillar Post

Date: February, 2023 | CategoryCompliance Author: Hana Trokic


The Food and Drug Administration (FDA) sets strict labeling requirements and guidelines for food, drugs, cosmetics, and medical devices to name a few. The goal of these rules and regulations is to ensure that consumers have accurate and complete information about the products they purchase and consume.  

These guidelines cover everything from product ingredients and information, to labeling and packaging requirements. It’s important for manufacturers and distributors to understand and comply with these regulations to avoid potential legal and financial downfalls along with ensuring the complete safety of the consumer. 

This post will provide an overview of the FDA’s labeling requirements for specific markets and offer resources on how to stay FDA compliant.

Want to learn more about compliance, proofreading, and quality control? Read more content from GlobalVision here!

What is the FDA?

The Food and Drug Administration, otherwise known as the FDA, is responsible for protecting public and consumer health by ensuring the safety, efficacy, and security of food, drugs, medical devices, cosmetics, and more.

A federal agency within the U.S. Department of Health and Human Services, the FDA is responsible for:

  • Reviewing and approving new foods, drugs, cosmetics, and medical devices before they are sold to the public
  • Inspecting companies that make and distribute food, cosmetics, drugs, and medical devices
  • Monitoring the safety of food, drugs, cosmetics, and medical devices after they have been approved and are on the market
  • Providing information to the public about the safety and effectiveness of food, drugs, cosmetics, and medical devices
  • Regulating the labeling and advertising of food, drugs, cosmetics, and medical devices
  • Enforcing laws that protect consumers from unsafe or misbranded products

What are FDA Labeling Requirements?

FDA Labeling Requirements Pillar Post

FDA labeling requirements are guidelines and regulations set for the labeling of food, drug, cosmetics, and medical device products. 

These guidelines ensure that consumers have accurate and complete information about the products they purchase. 

The FDA labeling requirements cover a wide range of information, including:

  • Packaging and labeling requirements for specific products.
  • Ingredient list
  • Health claims and nutrient content claims
  • Warning statements where applicable 
  • Nutrition information for food labeling 
  • Allergens

Manufacturers and distributors must thoroughly understand and comply with all FDA labeling requirements to ensure a safe and reliable product along with getting their products to market faster. They also need to keep updated with FDA regulations as they change over time and manufacturers want to ensure the consistent compliance of their products. 

Historical Context of FDA Labeling Requirements

The history of FDA labeling requirements goes back to the late 19th century when the U.S. government first began to regulate the safety and purity of food and drugs. The first federal food and drug law, the Pure Food and Drug Act of 1906, was passed in response to public concern about the safety of food and drugs that were being sold across state lines. 

This law required that food and drugs be labeled with accurate information about their contents and prohibited the sale of misbranded or adulterated products

Over the years, the FDA has continued to update and strengthen its labeling regulations to keep pace with advances in science and technology, as well as changes in consumer preferences. 

For example, in the 1960s, the FDA introduced regulations requiring that food labels include nutritional information. In the 1990s, the FDA began to require that food labels list the presence of major food allergens.

The most recent major update to the FDA’s labeling regulations came in 2016 when the agency issued the final rule for the Nutrition Fact Label for packaged foods. This rule, which went into effect in 2020, requires that food labels list the amount of added sugars and gives manufacturers the option to declare the amount of potassium and vitamin D in their products.

In addition to these, the FDA also has updated regulations for different products like dietary supplements, cosmetics, medical devices, tobacco, and others.

FDA Labeling Requirements for Different Markets 

FDA labeling requirements vary from market, product, and commodity. Each product, depending on its intention of use, has its own set of requirements that manufacturers need to follow. 

The FDA differentiates between markets so that proper instructions and specific requirements can be given to ensure consumer and product safety and avoid recalls, and potential financial losses.     

The main markets that will be analyzed in this post are: 

  • FDA labeling requirements for medical devices
  • FDA labeling requirements for drugs
  • FDA cosmetics labeling requirements
  • FDA labeling requirements for food 

Following FDA requirements is complicated. We make it easy. 

Keep up with the latest in compliance, quality control, and proofreading by signing up for our newsletter

FDA Labeling Requirements for Medical Devices 

Medical devices can range from simple to complex. Regardless of its complexity, there is a constant amongst them all. They all need to be tested and approved to meet FDA requirements and compliance. 

Types of Medical Devices and Their Regulations 

A medical device can range from the simplest household item found in everyone’s pantry, like a band-aid, to more complex technology like an x-ray machine. Regulatory authorities globally have put into place risk classifications that group devices into categories based on their potential harm if misused, the complexity of the device, and certain use characteristics. 

These classifications are essential to ensure safety and ease the marketing and placement of devices. It also sets a standard for testing where officials know, according to classification, how much testing a device needs to undergo to be deemed safe and ready for patient use. 

Medical Device Classification 

In the United States, the FDA has classified medical devices into three categories based on the level of control needed to ensure the safety of use. The classifications are: 

  • Class I – Low risks: Includes devices such as bandages, toothbrushes, floss, and hospital beds. Only requires general controls.
  • Class II – Medium Risk: Includes contact lenses, pregnancy tests, and catheters. Requires general controls as well as pre-market notifications 
  • Class III – High Risk: Includes respirators, prosthetics, and pacemakers. Requires all general controls along with special controls and pre-market approval. 

Regulations and Standardizations 

Regardless of their classification, it’s important that all medical devices adhere to a certain set of regulations and standardizations. Much like pharmaceuticals, medical devices are treated with similar rigor and are highly regulated. 

The FDA offers a detailed overview of all the regulations devices need to follow in order to be deemed fit for use by the general public. The International Organization for Standardization (ISO) sets the standards and convenes them for ease of implementation in the industry.

Some regulations that are put in place for medical devices include: 

  • Establishment registration 
  • Medical device listing 
  • Pre-Market notification 
  • Pre-Market approval 
  • Quality system regulation 
  • Labeling 
  • Medical device reporting 

Labels and Labeling 

The FDA defines a label as a display of written, printed, or graphic matter upon the immediate container of any article” or “all labels and other written, printed, or graphic matter.”  

As such, labels are the first point of contact for information for many medical practitioners, patients, and consumers, and need to be accurate to avoid confusion or life-threatening consequences.  

The FDA breaks down label regulations for medical devices and clearly defines them by the following: 

  • General device labeling 
  • Use of symbols 
  • Unique device identification 
  • Good manufacturing practices 
  • General electronic products 

These regulations are in place to primarily ensure that the products and devices in question are being used as they are intended and that the safety of those using them is guaranteed. 

For an in-depth look at how you can comply with FDA labeling requirements for medical devices, read our thorough blog post here. 

FDA Drug Labeling Requirements

For highly regulated industries like pharmaceuticals, following FDA drug labeling requirements is one of the most crucial aspects of the product lifecycle

The accuracy of drug labels ensures that patients and consumers are being given proper instructions and dosages of a prescribed drug. Label accuracy also ensures that pharmaceutical companies avoid life-threatening side effects for their consumers, large recalls, and colossal financial downfalls. 

The Highly Regulated Pharmaceutical Industry 

When it comes to drug labeling, the FDA’s primary purpose and concern are to ensure patient safety and provide healthcare professionals with information about the drug and how it should be prescribed. 

Some of the FDA’s drug label requirements include

  • Highlights (a concise summary of label information)
  • Full prescribing information
  • Recent Major Changes 
  • Indications and Usage 
  • Dosage & Administration 
  • Dosage Forms & Strengths 
  • Contraindications 
  • Warnings & Precautions 
  • Adverse Reactions (listing of most common adverse reactions) 
  • Drug Interactions 

For more information about the importance of FDA drug labeling requirements, read our comprehensive blog post

FDA Cosmetic Labeling Requirements 

All cosmetics marketed globally must comply with provisions set by the governing body of that specific country or region. In the United States, the FDA is responsible for regulating cosmetic labeling with the main goal of ensuring consumer safety and avoiding fraudulent and deceptive statements. 

What are Cosmetics? 

The FDA defines cosmetics as “articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions.

Some products that fall under this category include creams, lotions, perfumes, make-up, shampoos, toothpaste, and deodorants.

While it may seem clear what cosmetics are, manufacturers need to be careful when creating, labeling, and marketing their cosmetic products to ensure they fit under the FDA’s definition and regulations. 

If not appropriately labeled, some claims may cause a product to fall under the category of a drug, in which case it has to undergo a set of regulations that differ significantly from cosmetics. 

Though sometimes lines can be blurred, manufacturers must understand the difference between cosmetics and drugs and label their products accordingly to avoid potential complications, fines, and recalls. 

Cosmetic Labeling 

Cosmetic products distributed in the United States must comply with all label regulations established by the FDA. Labels are otherwise considered all written, printed, or graphic matter on or accompanying a product.  

The FDA requires that all label statements appear on the inside and outside of the packaging and wrapping. 

It is also important to note that false and misleading claims and wrongly labeled products that do not follow FDA cosmetic labeling requirements and regulations may be subject to regulatory action. 

How to Correctly Label Cosmetics

To ensure the proper placement of cosmetics on the market and that consumers use them appropriately, manufacturers need to take note of adequate labeling requirements and adhere to them as strictly as possible. 

A cosmetic label must contain the following

  • Product identity
  • Net contents 
  • Declaration of Ingredients
  • Label warnings

If you want to learn all about FDA cosmetic labeling requirements and how to meet them with complete ease, read our detailed blog post.

FDA Labeling Requirements for Food

Food labels have very defined rules regarding how they should be placed on packages and containers. 

General Food Labeling Requirements

Generally speaking, there are two ways to label food: 

  1. Place all required label statements on the front of the label panel.
  2. Place certain specified label statements on the principal display panel (PDP, or the part of a food label that is most likely to be displayed to the customer when for sale – the front label on a product) and other labeling on the information panel. 

No matter the food product, the PDP must display specific information critical for consumers. This includes the food name and the net quantity statement. Food must also include the information panel, which is usually placed to the right of the PDP.  

The information panel refers to statements that are generally required to be placed together. They usually include information such as the name and address of the manufacturer, ingredient list, nutrition labeling, and allergy labeling. 

It is also important to note that label standardizations must be followed to ensure consistent and easy-to-read labels. 

The FDA requires that you use a prominent print size and that the font is clear and legible through specified letter height. Additional formatting is also detailed in FDA guidelines to ensure that text is easy to read on different backgrounds and artwork. 

Manufacturers must also ensure that all of their food labels contain the following: 

  • Name of food 
  • Net quantity of contents statements 
  • Ingredients list 
  • Food allergen labeling 
  • Nutrition labeling 
  • Nutrition content claims 

Want to take a deep dive into FDA food labeling requirements? We have the blog post just for you.

How to Meet FDA Labeling Requirements

Regardless of the food, drug, cosmetic, or medical device you want to send out to market, there are constants among them all that help ensure their safety and quality. 

Best Practices for Preparing Labels for FDA Review

There are several best practices for preparing labels for FDA review:

  • Ensure that the label accurately reflects the contents of the product and that it meets all legal requirements for labeling.
  • Include all required information, such as the product’s name, ingredients, and nutritional information when needed.
  • Provide detailed information about the product, including how to use it, storage instructions, and any other relevant information.
  • Make sure that any health or safety claims are supported by scientific evidence and are not misleading.
  • Provide allergen information, if any, on the packaging when needed.
  • Use clear and conspicuous language that is easy to read and understand.
  • Use appropriate formatting and layout to make the label easy to read, including using contrasting colors and appropriate font sizes.
  • Make sure that the label is consistent with any advertising or promotional materials for the product.
  • Provide contact information for the manufacturer or distributor, such as address, phone number, or website.

The Importance of Label Accuracy 

When we look at highly regulated products such as pharmaceuticals, cosmetics, and medical devices, the first thing our eyes go to, is the label. This is where we know we will find all the information needed about that said product. 

The information stated on that very piece of content determines whether or not a consumer will find the product suitable and reliable enough to purchase and use. Because of this, the accuracy of labels should be of high priority. 

Label accuracy is crucial as it details the products:

  • Safety: Accurate labels ensure that consumers are aware of any potential hazards or allergies associated with the product, which can help prevent harm or injury.
  • Legal compliance: Accurate labels help ensure compliance with these regulations and reduce the risk of fines or legal action.
  • Trust and credibility: Accurate labels help build trust and credibility with consumers, as they demonstrate that a company is committed to providing honest and transparent information about its products.
  • Liability: Inaccurate labeling can lead to product liability claims from consumers who have suffered harm or injury as a result of using a product.

In order to have only the highest quality products making it into the hands of consumers, label accuracy should be a top priority throughout the entire product development process. It is important to proof, check, and, review, labels to ensure that they are accurate, complete, and up-to-date.

Common Label Mistakes to Avoid

As inaccurate labels can lead to disastrous consequences for highly regulated industries, proofreading, reviewing, and checking labels should be a thorough and precise process. Mistakes should be avoided by any means necessary. 

Some common label mistakes that manufacturers should avoid include:

  • Incorrect or incomplete information: Failing to provide all required information or providing incorrect information on a label.
  • Poor readability: Using small font sizes, poor contrast, or a confusing layout can make it difficult for consumers to read and understand labels.
  • Inadequate allergen labeling: Failing to properly label potential allergens can lead to serious health consequences for certain individuals.
  • Outdated information: Failing to update a label with new information, such as changes in ingredients or nutritional information, can be misleading to consumers.
  • Non-compliance with regulatory requirements: Labels must comply with all applicable laws and regulations, such as those related to nutrition, health and safety claims, and ingredient labeling.
  • Misleading or false claims: Making false or misleading claims on a label can result in legal action and damage to a company’s reputation.

Best Practices for Maintaining FDA Label Compliance

With many rules, regulations, and requirements to follow, it’s no surprise that such heavy importance is placed on label accuracy. For perspective, in drug labeling, it is estimated that over 50% of medication use errors are associated with poor labels. 

Though this includes patient misunderstandings, it is generally believed that implementing standardizations such as text, language, typography, and other display standards will drastically reduce errors in drug labels. 

Along with patient safety, it is also important to note that labeling errors lead to significant recalls and financial losses, which are more frequent than one would think. 

Clinically important drug recalls occur approximately once per month in the United States. For perspective on just how significant these financial impacts can be, Johnson and Johnson lost roughly $600 million in sales after closing a distribution site due to a recall.

Because of this, best practices should be put in place to ensure that labels are accurate while maintaining manufacturing and distribution efficiency and speed. 

One certain method that ensures label accuracy is the implementation of automated quality control, or more precisely, a file comparison tool to check content and labels with complete ease and efficacy.  

What is File Comparison Technology?

Content for highly regulated products is produced at such rates and numbers that companies need to turn to technology to help ensure the accuracy of their content and labeling along with all technical documentation. 

In other words, file comparison technology is the ideal solution they are looking for. 

File comparison technology proofreads documents and files in seconds. The software works by overlaying two files to find discrepancies between the two. No matter how small the errors or differences may be, the software will detect them and pinpoint their exact location on the file.

The software can detect errors in copy and artwork that is nearly impossible to see with the naked eye. Using a document comparison tool, errors and differences can be easily found in text, graphics, barcodes, braille, print, and color.  

The result is proofread and error-free labels and packaging in record time – every time. 

By introducing file comparison technology to your proofreading and reviewing processes, quality control departments in regulated industries can avoid unnecessary and hasty product mistakes that can be easily corrected and avoided. 

The technology gives manufacturers confidence that their products and accompanying labels reach the hands of consumers in pristine condition – down to the last period. 

Find out more about how file comparison technology can help quality control teams in regulated industries.

Your New Automated Solution

Many large global corporations in highly regulated industries have yet to implement new technologies that increase workflow efficiency. 

In some cases, many still rely on manual and labor-intensive proofreading and reviewing processes prone to mistakes, leaving huge potential for operations to be optimized and streamlined for maximum efficiency. 

Automated quality control or a file comparison tool inspects content and artwork with complete ease, lightning speed, and increased accuracy.  

To keep up with increasing global consumer demands, regulated industries create an immeasurable amount of products, each with its own packaging, labeling, and documentation. This content must be meticulously reviewed and proofread to ensure that the final product is error-free. 

 Manually proofreading this amount of content is not an efficient solution for companies that need to keep up with growing demands. File comparison software offers a foolproof solution to ensure all this generated content is checked and proofread perfectly. 

 This advancement in proofreading processes eliminates the need for manual document inspections and leaves it up to technology. The software conducts digital checks for discrepancies in text, spelling, graphics, color, and more. 

The software conducts thorough inspections in a fraction of the time and ensures that labels and content are 100% accurate before going out to the hands of patients and consumers. 

 This technological advancement ultimately increases productivity and workflow efficiency and offers endless benefits unmatched by manual inspections. Not only does automated proofreading software help ease the proofreading process, it simply makes proofreading better. 

Keep Up with FDA Labeling Requirements 

If you want to keep up with FDA labeling requirements with complete ease, switch to automated quality control. A trusted technology, GlobalVision’s innovative automated solutions have been solving problems for regulated industries globally for over thirty years.  

By using GlobalVision to eliminate time-consuming and inaccurate manual checks, the largest pharma companies worldwide cut review times by 89%. Just by making the simple switch to automated quality control, top companies got critical healthcare products into the hands of consumers faster and with complete confidence that their labels and content are 100% accurate and FDA compliant.

To name only a few, GlobalVision has helped:

Ensuring that you meet all FDA drug labeling requirements is far from easy. Yet, through the simple introduction of automated quality control, companies can rest assured that they are drastically eliminating the risk of human error, getting their product to market faster with fewer revision cycles, and reducing the risk of costly recalls and misprints. 

Ready to Automate Your Workflows? 

To ensure market success and error-free, perfect labels, regulated industries must streamline their quality control processes. The simple Implementation of file comparison technology helps teams create flawless labels, speeds up the content creation process and revision times, and gets products to market in record time.   

The benefits a file comparison tool brings to manufacturers are countless and, in most cases, are a crucial company resource. The only way manufacturers can be completely confident that their content and products are error-free is through fast, accurate, and trusted software such as file comparison technology.  

Ready to step into the world of automated proofreading? Request a demo of our innovative text comparison software and see how this technology can revolutionize your everyday business practices. Transform your quality control processes with GlobalVision’s cloud-based quality inspection tool. 

Also, to learn more about how technology can help manage regulatory compliance, check out GlobalVision’s guide Digital Transformation for Pharmaceutical Packaging Quality.

Ensure Your Labels Meet all FDA Drug Labeling Requirements with Automated Quality Control

Date: November, 2022 | CategoryQuality Author: Hana Trokic


For highly regulated industries like pharmaceuticals, following FDA drug labeling requirements is one of the most crucial aspects of the product lifecycle. With so many laws, rules, and regulations to follow, the task of creating documentation, labels, and content surrounding a single drug or product quickly becomes stressful and tedious.  

Yet, drug label requirements are in place for a reason – and a good one at that. The accuracy of drug labels ensures that patients and consumers are being given proper instructions and dosages of a prescribed drug. Label accuracy also ensures that pharmaceutical companies avoid life-threatening side effects for their consumers, large recalls, and colossal financial downfalls.

With so much on the line, pharmaceutical companies cannot risk label errors slipping through.    

Thankfully, software shortcuts such as automated quality control is a one-stop shop for your compliance needs that makes sure your labels meet any and all FDA drug labeling requirements. 

Automated quality control is an easy solution that allows you to proofread labels and content in record time. Not only does it decrease proofreading and review times, but it also decreases errors while increasing the efficiency of your workflows. 

With this comprehensive software solution, you can ensure that all of your labels follow FDA requirements while being accurate and completely error-free.    

The Highly Regulated Pharmaceutical Industry 

Spell Check image
When it comes to drug labeling, the FDA’s primary purpose and concern are to ensure patient safety and provide healthcare professionals with information about the drug and how it should be prescribed. Some of the
FDA’s drug label requirements include

  • Highlights (a concise summary of label information)
  • Full prescribing information
  • Recent Major Changes 
  • Indications and Usage 
  • Dosage & Administration 
  • Dosage Forms & Strengths 
  • Contraindications 
  • Warnings & Precautions 
  • Adverse Reactions (listing of most common adverse reactions) 
  • Drug Interactions 

With so many regulations to follow, it’s no surprise that such heavy importance is placed on label accuracy. Even so, it is estimated that over 50% of medication use errors are associated with poor drug labeling. Though this includes patient misunderstandings, it is generally believed that implementing standardizations such as text, language, typography, and other display standards will drastically reduce errors in drug labels. 

Along with patient safety, it is also important to note that labeling errors lead to significant recalls and financial losses, which are more frequent than you would think. Clinically important drug recalls occur approximately once per month in the United States. For perspective on just how significant these financial impacts can be, Johnson and Johnson lost roughly $600 million in sales after closing a distribution site due to a recall.

To avoid the detrimental consequences that label errors bring, pharmaceutical companies need to implement a functioning proofreading and reviewing process. They must inspect labels, artwork, and content at every step of production, ensuring the accuracy of the complete file. 

Innovations in automation, such as GlobalVision’s file comparison software, allow pharmaceutical companies to implement an all-in-one quality control platform that inspects complete files, including text, spelling, artwork, graphics, braille, and barcodes, at every stage of production. It allows for label standardization as it detects discrepancies no matter how small, making it easier for companies to ensure their labels are following the standards set in place.

Through automated quality control, companies can be sure that their labels are consistently accurate, and meet all standards and compliance guidelines, while meeting FDA drug labeling requirements with increased ease and efficiency. 

The Benefits of Automated Quality Control 

Spell Check image
Many large global pharmaceutical companies have yet to implement new technologies that increase workflow efficiency. 

In some cases, many still rely on manual and labor-intensive proofreading and reviewing processes prone to mistakes, leaving huge potential for operations to be optimized and streamlined for maximum efficiency. 

The solution, thankfully, is simple. Automated quality control inspects content and artwork with complete ease, lightning speed, and increased accuracy.  

To keep up with increasing global consumer demands, pharmaceutical companies are creating almost immeasurable amounts of products, each with its own packaging, labeling, and documentation. This content must be meticulously reviewed and proofread to ensure that the final product is error-free. 

Manually proofreading this amount of content is not an efficient solution for companies that need to keep up with growing demands. Automated proofreading software offers a foolproof solution to ensure all this generated content is checked and proofread perfectly. 

This advancement in proofreading processes eliminates the need for manual document inspections and leaves it up to technology. The software conducts digital checks for discrepancies in text, spelling, graphics, color, and more. The software conducts thorough inspections in a fraction of the time and ensures that labels and content are 100% accurate before going out to the hands of patients and consumers. 

This technological advancement ultimately increases productivity and workflow efficiency and offers endless benefits unmatched by manual inspections. Not only does automated proofreading software help ease the proofreading process, it simply makes proofreading better. 

Keep Up with FDA Drug Labeling Requirements 

Spell Check imageIf you want to keep up with FDA drug labeling requirements with complete ease, switch to automated quality control. A trusted technology, GlobalVision’s innovative automated solutions have been solving problems for pharmaceutical companies globally for over thirty years.  

By using GlobalVision to eliminate time-consuming and inaccurate manual checks, the largest pharma companies worldwide cut review times by 89%. Just by making the simple switch to automated quality control, top companies got critical healthcare products into the hands of consumers faster and with complete confidence that their labels and content are 100% accurate and FDA compliant.

To name only a few, GlobalVision has helped:

Ensuring that you meet all FDA drug labeling requirements is far from easy. Yet, through the simple introduction of automated quality control, companies can rest assured that they are drastically eliminating the risk of human error, getting their product to market faster with fewer revision cycles, and reducing the risk of costly recalls and misprints. 

Ensure Consistent Quality 

With endless benefits and countless advantages to your company’s revision processes, automated quality control is the leading solution for pharmaceutical companies that wish to ensure the quality of their labels and content. All the while ensuring they meet all FDA labeling requirements. 

Enhance your proofreading practices and make the switch today. See how automated quality control can streamline your business’s workflows by allowing you to proofread critical content at scale while maintaining the complete accuracy of your labels and content.   

Discover firsthand the benefits of automated quality control. Request a demo of GlobalVision, and get started today

6 Ways Businesses Can Overcome Data Integrity Issues
 
 

Date: September 14, 2021 | Category: Compliance | Author: Kayla Caticchio


In today’s digital age, a new threat presents itself to businesses that are heavily reliant on data. Many data-driven organizations rely on data integrity to be able to conduct their business operations without issues. These businesses must take great care to ensure the consistency, accuracy, validity, and safety of data. Failure to do so can result in the corruption of information that can negatively affect all aspects of a business. To avoid being put in a vulnerable position, there are many steps that can be taken to help overcome data integrity issues.


What is Data Integrity?illustration of a lock

Data integrity refers to the reliability and trustworthiness of data over the course of its lifecycle. Data can be either valid, invalid, or in the process of becoming valid. Error-checking and validation processes are methods often used to ensure data integrity.

 

Why is Data Integrity Important?

illustration of security windows

Data is perpetually vulnerable to corruption of any kind. The degree of its vulnerability depends on the efforts taken to preserve its original state over time. These efforts exist to preserve the reliability and trustworthiness of data to ensure proper decision-making within an organization. Any impactful decision within a business requires data to be accurate and consistently valid in order for any progress to occur.

 

What Are the Threats to Data Integrity?Illustration of a person facing data integrity issues

Threats to data integrity can appear in many different forms. Threats can be accidental or voluntary, taking the form of cyber attacks with the intent to alter or destroy data. Some of the most common threats, however, are often internal. Examples include:

  • Human error
  • Unintended actions
  • Security errors
  • Malware
  • Compromised hardware

 

How Can Businesses Overcome Data Integrity Issues?

  1. Validate Input: Documented evidence of validation is a crucial way to ensure that input data is accurate. Once a data set is received, it should always be systematically verified.
  2. Validate Data: Ensuring data meets pre-determined specifications and key attributes is crucial to ensuring its validity and the system in which it passes through.
  3. Remove Unnecessary Data: Duplicate files and unidentified data can potentially open doors to unwanted intruders set on exploiting or corrupting information.illustration of security process and checklist
  4. Data Back-Ups: Permanent data loss is a real threat to businesses. Staying on top of routine backup checks is crucial to avoid losing critical information. Businesses should be proactive in creating a recovery strategy in the event of an unexpected data loss or application error. This will help to restore any losses that could potentially occur.
  5. Manage Access Control: Setting limits and controls on who can access certain information within an organization is crucial in protecting data from unauthorized users, including intruders and impersonators. Actions must be taken to ensure that the unwanted spread of sensitive information is limited. Furthermore, the importance of physical access controls must not be neglected. Businesses should take care to protect places like server rooms that can be especially vulnerable to corruption.
  6. Traceability: Data integrity relies heavily on the ability to track down the source of a breach at any point within operations. Ensuring that audit trails are consistently in place helps to provide security in the event of a breach and allows organizations to identify the source.

 

Overcoming Data Integrity IssuesIllustration of someone using GlobalVision to address data integrity issues

Data is useless without the underlying assumption that it is reliable and accurate. Management is dependent on the accuracy and integrity of data to be able to make decisions. In addition to the methods mentioned above, automation technology can help businesses secure their data and other information. GlobalVision’s inspection technology features audit trails and other controls developed to meet compliance and data integrity requirements for regulated industries. To learn more, visit globalvision.co.

 

 


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