How to Ease the Labeling Proofreading Process for Medical Devices Blog Post

Date: November, 2022 | CategoryProofreading Author: Hana Trokic


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. 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. 

While there is a long list of requirements to meet to even be classified as a medical device by the FDA, once labeled, there are strict rules and regulations put in place to ensure its proper use along with patient and consumer safety. These rules surround all documentation associated with the device, including labels, packaging, and technical documentation.  

A long and tedious process, FDA labeling requirements for medical devices is rigorous for good reason. The detrimental consequences that can come with the improper use of devices are extremely high risk and companies make sure to take every precaution possible to avoid irreversible and potentially permanent problems. 

One way medical companies ensure the safety and quality of their products is through precise checks, reviews, and thorough proofreading. Every aspect of the device is inspected and reviewed to ensure no mistakes have slipped through and that the final product is error-free.

Yet, when companies rely on manual methods as their primary approach to proofreading and quality control, they are increasing their chances of producing faulty products, labels, and packaging, due to the heightened likelihood of human error. 

Luckily, pharmaceutical companies and medical device manufacturers don’t have to rely on manual methods anymore to ensure their label and content accuracy. They can now turn to automated quality control as their secret to flawless labels, artwork, and products. 

Types of Medical Devices and Their Regulations

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Medical devices can range from simple to complex. 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 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. 

Keeping up with these regulations is already an extremely complicated process, but simplifying workflows and streamlining processes to increase efficiency is very much possible. 

Once you ensure that your medical devices and labels are following all regulations and standardizations how can you ensure that the written, printed, and graphic matter of your products are error-free

A document comparison tool is the natural next step in your regulation and standardization process that enhances your labels and artwork and makes keeping up with regulations easy. In a fraction of the time, you will be able to check and inspect entire files and documents and increase the accuracy of labels while easing the FDA labeling requirements put in place for medical devices.    

Making FDA Labeling Requirements a Breeze

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While traditionally manual checks were the method by which medical device labels, packaging, and graphics, were inspected, in today’s modern, globalized markets, demand is too large to rely on outdated methodologies. 

Devices and accompanying content are being produced at such rates and numbers that companies need to turn to technology to help ensure the accuracy of their products along with all technical documentation. 

In other words, a text comparison tool is the ideal solution they are looking for. 

A text comparison tool 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. 

To avoid unnecessary and hasty product mistakes that can be easily corrected and avoided, introduce text comparison technology to your workflows to ensure your medical devices and labels reach the hands of consumers in pristine condition – down to the last period. 

Ready to Simplify Your Processes?

In an already complicated and highly regulated industry, keeping up with regulations can be complicated and hard to follow. 

Pharmaceutical companies and medical device manufacturers should search for solutions to help ease the FDA labeling requirements for medical devices while simultaneously increasing the accuracy of their labels and the efficiency of creating and printing them. 

Through the use of the right technology, such as text comparison technology, companies and manufacturers can see increased benefits in their workflows that result in better and more accurate products.  

Using trusted automated proofreading technology like GlobalVision, companies in regulated industries can automate their quality control and get products to market faster, with complete confidence.

To learn more about file comparison technology and how it can benefit your company, request a demo of GlobalVision today!

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 

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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 

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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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