Recycle to avoid waste on the print production floor

Date: November, 2020 | Category: Quality | Author: Seth Richtsmeier

From a business perspective, it makes sense to avoid waste whenever possible. Print waste in particular costs companies time and money, since any mistakes made during a print run will have to be corrected with additional resources. It’s more than just material waste — there’s also employee labor that must be factored in.

The True Costs of Excess Print Waste in Production

According to studies from Gartner, 50 percent of business waste is composed of paper products, with the average office worker going through 10,000 sheets of paper per year. These numbers alone are staggering and don’t even account for other print products such as boxes and packaging.

There are also other costs associated with printing, including ink, warehousing space, and postage. These additional fees can add up to 30 times the purchasing price of the paper itself – a significant expenditure.

Beyond the financial implications, there’s also the environmental impact of waste. With 40 percent of the world’s timber being cut down for paper production, brands and consumers alike should look for ways to limit excess scrap.

4 Steps to Minimize Print Production Waste

To reduce the amount of print and packaging waste created, there are several steps companies can take. Here are a few key recommendations.

  1. 1. Start with Employee Training

    Digital meetings can help to reduce paper wasteA common factor when it comes to waste is human error. From typos to incorrect colors and fonts to formatting issues, there are many ways things can go wrong. “Mistakes caused by human error can definitely turn into possible reprints and extra platemaking” says John Reinhardt, Marketing Director of Prairie State Group, a leading packaging company in Franklin Park, IL.

    As soon as a new employee joins the team, they should receive adequate training to ensure they know what’s acceptable, how to spot errors, and how to correct those errors. Training should continue on a regular basis to ensure that everyone is aware of best practices.

  2. 2. Review Pre-Press Files with Care

    Avoid waste on the print production floor team collaborationBefore sending projects off to print, run through the files a few times to catch any errors. It’s often best to have more than a single person check for mistakes, as it’s easy for a writer or designer to skip over their own errors.

    Catching typos and formatting issues early on saves time, money, and resources. Always have at least two sets of eyes review each file before sending off any major print job. It may help to have a checklist available with things to look out for, including updated logos, correct color swatches, common spelling mistakes, and anything else that may be looked over otherwise.

  3. 3. Automated Quality Control

    Avoid waste on the print production floorThere’s a reason it’s called human error – we’re all human and we all make mistakes. While it’s helpful to have multiple people review a print file, there’s always the chance of a problem slipping through the cracks. With automated quality control, the proofing process is easier, more efficient, and more accurate.

    Using digital inspections to compare proof documents against original files, conversion errors, and printing defects can be quickly detected and addressed. Users can review inspection reports and approve files for a full print run once ready. This early detection can prevent large-scale misprints, which saves the company from having to toss out entire batches. Again, this saves print materials, ink, coatings, and other costs associated with print waste. It also reduces the company’s environmental footprint (more on that below).

  4. 4. Inventory Management

    Avoid waste on the print production floor through inventory managementWhile printing materials with errors is wasteful, storage issues that can damage products can be just as detrimental. All paper-based products should be stored in cool, dry environments to prevent mildew. It’s also suggested that these products be protected from threats such as fire, water, and contaminants.

    These recommendations should be applied to raw materials as well as finished print products, which can be even more costly to replace due to ink and other coating costs.

Avoiding waste through recyclingMinimizing Environmental Impact

In addition to taking control of the waste stream by minimizing mistakes, companies should also consider the environmental implications of their practices. When choosing packaging materials, prioritize recyclable paper products. This may involve choosing different coatings and ink to ensure the package can be recycled with other paper and cardboard materials.

There are also several packaging materials that don’t involve paper at all. Corn- and mushroom-based packaging are gaining traction as eco-friendly options. A seaweed-based material called agar is in the early stages of development as a viable packaging alternative as well. Keep an open mind about new products and consider how they can fit into your packaging stream.

GlobalVision's digital proofreading of nested sheetsAvoid Print Waste with Quality Control

Ultimately, the best way to reduce waste is to invest in your quality control. Eliminating the risk of misprints and formatting issues will save countless reams of paper and other materials. Automated quality control systems are a necessity for waste prevention. As Sales Manager Dave Mickiewicz from General Converting Inc. says “With [automated quality control], sheets can be quickly inspected to check for smashes, hickeys, content errors. It has definitely helped eliminate lost time and wasted materials”. 

To learn how your company can benefit from significant returns by automating your quality control process, check out GlobalVision’s guide Shifting Gears from Manual to Automated Quality Control.


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Key elements to inspect when creating brand packaging

Date: October, 2020 | Category: Quality | Author: Seth Richtsmeier

When you think about your products, what sets them apart from others in the industry? Are they more durable than the competition? Do they have better features or a more user-friendly design? Why should customers choose you over another company?

By answering these questions, business leaders can begin to establish a brand identity. Just as people have different personalities, so do brands. Ideally, your brand’s identity should click with that of your customers. It should also be readily apparent in all interactions your audience has with the company – each customer touchpoint must conform to brand identity, from customer support to product delivery.

The Impact of Brand Identity

Proper error-free packaging increases consumer appreciation Many businesses understand the basics of brand identity packaging, which includes choosing the right colors and logos to visually represent the company. While this is a good start, it only scratches the surface of all that’s included when building brand identity.

The brand identity encompasses everything that sets one company apart from another. It’s more than products and services; it’s how a company delivers those services. How a company meets expectations, connects with customers, and defines its values – all these factors define a brand’s identity. A company with a strong identity that is known for providing exceptional service and support and remaining true to its values will make customers feel more confident doing business with them.

Brand Packaging in Building Brand Identity

Approved error-free brand packaging


Have you ever received a package in the mail, only to open it up and discover that the item you purchased was broken? The most important role of packaging is to protect an item during transit, whether it’s being shipped across the world or simply needs to survive a car ride home. Look for options that fit the needs of the product while also fitting in with overall brand values. For example, if your company is committed to sustainability, select materials that are easily recyclable and renewable.

Remember that brand packaging identity is an extension of your product identity. A negative unboxing experience will reflect poorly on the entire brand. Alternatively, a surprisingly positive experience will stay in people’s minds when it’s time to consider their next purchase.

Top Considerations for Print PackagingElements used to ensure packaging integrity

There are many considerations to keep in mind when developing print packaging and branding. Ultimately, the customer and their experience should be top of mind when selecting packaging options.


Since the most important job of packaging is to protect the product, consider the weight of the items being shipped, the durability of materials used, and which types of filler will best protect products without leaving a mess for customers to clean up after opening.


To build a truly inclusive brand identity, think about challenges faced by consumers and how your packaging can solve them. Including braille text on the packaging, for instance, can allow those with visual impairments to read important information on the package. Similarly, large, easy-to-read fonts can help customers know what they’re getting.

Ease of Use

This goes along with accessibility, but each customer should be able to easily open the packaging to retrieve the product inside. Ever wrestled with an item encased in tight plastic like a Jurassic mosquito stuck in amber? Packages should be designed to be easily opened with standard tools like scissors. If a product is too difficult to open (like anything packed in plastic clamshells), this can create a frustrating unboxing experience.

If instructions are necessary to open the package or to operate the product, it’s also important for those instructions to be easy to find, read, and understand.

Brand Identity

Your branding and packaging go hand in hand.

This is a great opportunity to include your logo, company colors, taglines, and any other identifiers. As soon as people see the package, they should be able to recognize where it’s from. Think of the signature smile that accompanies an Amazon box or the nearly all-blue box from A quick identifier that lets customers know exactly where a package is coming from without having to open the box.


Every line of text represents your brand identity, so make sure it’s all accurate! A single misspelling on thousands of boxes can have expensive repercussions. Error-free packaging is vital to maintaining your image as a trusted authority and leader in your industry.

You also must ensure that all information included within the packaging is correct. If there’s a user manual or guide, bullet points should be accurate and make sense.

Cohesive Packaging and Branding Identity

Building a strong brand identity through packaging

Now that you understand the impact of brand identity and how to go about establishing it through packaging, it’s time to put these lessons into practice.

Sit down with team members across the organization to get a sense of how they define the overall brand. Which words, themes, and values stand out the most? Then, gather customer data to see what they prioritize when choosing a company to work with. Finding the points of intersection is the key to building a cohesive identity that connects with audiences and remains authentic to the company.

Your packaging and branding identity should always align with product identity, as well as with customer demands and expectations. Make sure that you see every option from the customer’s perspective to ensure a positive overall experience that reflects well on the entire organization.

Want to overhaul your brand’s packaging but need some help with the details? Request a personalized demo to transform your company’s quality control process.


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Learn How Some of the World’s top Pharma Companies have Cracked the Efficiency Code with Automation

illustration of different packaging

Date: May, 2020 | CategoryqualityAuthor: Luisa Berger

Developing pharmaceutical packaging can feel as complicated and lengthy of a process as developing the product itself.

If left without logical structure, this process quickly becomes vulnerable to inconsistencies and human limitations that can slow down workflows, cause unnecessary reworks, and put companies at risk of a recall. The good news: implementing standardized processes and leveraging automation can protect companies from these vulnerabilities and accelerate their existing workflows. 

Pharmaceutical Artwork Management: A Non-Linear Process

Illustration of a man solving a circle puzzle

The creation of a pharmaceutical label or package would seem to be a relatively linear process as the information moves from regulatory departments and core data sheets to designers and layouts and finally to printers and finished materials.

Yet, this relatively straightforward sequence quickly erodes with the countless revision and approval cycles that are introduced as a result of new upstream data or information, regional requirements, regulatory feedback, and many other influencing factors. The development and review of each of these stages can already be a lengthy process, making any additional errors or inconsistencies introduced along these workflows a potential bottleneck or implication further downstream. 

Ideally, at every new version or hand-off, a comprehensive review and comparison of the current version to the previously approved one would take place. The goal is to ensure that by verifying content accuracy and correcting errors and inconsistencies at each stage, the entire process can be streamlined for more efficient and effective work, rather than frequent, easily avoidable reworks.

While, in theory, it sounds great to thoroughly inspect every project and every version like this, in reality, these reviews can take hours, even days when manually checking content that can range from less than 12 words to over 120 pages. Enter automation

Automation for Packaging Artwork Management 

GlobalVision Product comparison tool screenshot

Automated inspection technologies are to these processes what a calculator is to engineering: a tool that quickly, reliably, and with precision performs functions that humans can do, but with significantly more time and greater room for error.

Automation acts as an aid, not a replacement, for human participation. Rather, by allowing computers to do what they do best, teams are actually able to apply their attention and efforts to those actions that, alongside these automated processes, keep projects moving forward and time-to-market speeding up. 

From original source documents and manuscripts to design layouts and graphics to physical proofs and finished materials, automation can quickly and consistently verify the diverse components and elements that make up these projects. With text verification tools, you can ensure that your copy was properly transcribed or conserved across versions and formats, fool-proofing that no errors or inconsistencies slipped through review.

Graphics errors, like missing logos, inaccurate graph drawings, or color inconsistencies, can be instantly highlighted using pixel overlay technologies. Even verification processes that already benefit from some innovation and standardization, like barcode and braille authentication and translation, can be further optimized using automation for faster, more informative results. Automated solutions like these are readily available tools that can be easily leveraged to transform productivity and optimize outputs.  

Bridging the Gaps in Artwork Management 

Illustration of teams working together

While these tools and capabilities can transform traditional processes and manual verification methods, when integrated into existing product lifecycle management (PLM) systems, these solutions can bridge the existing quality gaps both internally, within and across departments, and externally with vendors. 

In today’s context, most pharmaceutical and life science companies utilize software and digital management systems for organizing projects, document management, and other workflows. By seamlessly integrating into these existing platforms, these routine quality checks become an easily accessible and implementable procedure for verifying each contribution that benefits the efficiency and collaboration of everyone participating in that workflow. 

Given that companies in this space outsource those functions that are not within their necessary expertise, whether marketing, printing, or other vendor services, quality standards must also apply to this level. When both company and vendor employ the same quality control tools, there is a common language and agreed-upon standard that both parties are committed to upholding and remaining accountable to. 

Beyond Workflows

Illustration of different types of graphs

While these tools are optimizing the artwork development and review process for faster, more streamlined projects, these integrations also allow businesses to collect relevant data on areas of their workflows, like the number of revisions, common errors, vendor performance, and other relevant metrics. Ultimately, these insights can help inform further strategies and business efforts for optimization and improvement in these areas and beyond. 

Unlike desktop-only or shared, physical verification tools, cloud-based solutions allow teams to work independently and securely wherever they can access an internet browser. Whether integrating with existing systems or opting for a cloud-based solution, companies can ensure that their team’s ability to access their quality control tools and uphold standards is disruption-proof.

With more companies supporting working remotely, or external conditions limiting access to workplaces or tools, these easily accessible solutions allow teams to continue thriving and delivering flawless results, regardless of the circumstances. 

The artwork management and creation process is an extensive undertaking that involves wide-ranging collaborative efforts across and beyond pharmaceutical companies. By implementing coherent processes and leveraging automated solutions, these non-linear workflows can become more streamlined for faster outputs and fewer errors slipping through the cracks.

Curious about what effects this kind of automation could have on your own workflow? Book a process consultation with one of our representatives to explore how automation could work for you.


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Get your Complete Guide to Meeting FDA Labeling Requirements Here

Learn How Some of the World’s top Pharma Companies have Cracked the Efficiency Code with Automation

Diagram showing Digimarc Barcodes

Date: March, 2020 | CategoryqualityAuthor:Kayla Caticchio


A new era of barcodes is here. With big-name retailers and consumer goods companies replacing traditional barcodes with Digimarc barcodes, printers are facing more challenges than ever when it comes to verifying these modern codes. 

GlobalVision’s latest integration, Digimarc Verify, gives users the ability to verify and grade all Digimarc barcodes with or without the use of a scanner, speeding up and simplifying the quality control process. 

Read Now: Digimarc Verify for GlobalVision Press Release

What is a Digimarc Barcode?

A Digimarc Barcode is an advanced barcode that can be applied to any print or packaging material. It links interactive content, like product information, when scanned with an enabled scanner or mobile device. Known as the ‘Invisible Barcode’, Digimarc codes on labels and packaging contain the same information as a UPC barcode but generally can’t be detected by the human eye.

Digimarc barcodes offer several benefits over traditional ones. Many retailers are making the switch because they’re faster, more secure, more reliable, and more versatile than traditional barcodes. They also occupy no space on a product’s packaging, giving the company more space to work with when it comes to artwork and branding. Retailers appreciate the fact that Digimarc Barcodes speed up the checkout process as people can scan their products without having to locate a barcode on the packaging.

Inspection report screenshot

The Importance of Barcode Inspections

Although barcodes have significantly evolved since their introduction in the 1970s, the importance of ensuring barcode functionality has never been lost.

First and foremost, barcodes must be checked to ensure that they’re present and scannable. Next, the barcode on a printed packaging material has to match the product inside. Finally, printers must give their clients the assurance that their products will scan at the store. If a barcode doesn’t scan, both the retailer and the brand run the risk of losing money. 

For prepress operators and printers, the main challenge with checking Digimarc codes is that they can’t be located just by looking at the packaging. This makes it difficult for any traditional barcode reader to verify the functionality of the barcode.  

With Digimarc Verify for GlobalVision, prepress operators and printers now have an easy and efficient way to validate that the packaging containing Digimarc Barcodes is ready to hit the shelves. This integration gives them the ability to automatically confirm that the Global Trade Identification Number (GTIN) in Digimarc Barcodes matches the GTIN in the UPC or EAN barcode. Overall, Digimarc Verify is designed to speed up and simplify the quality control process for those in charge of proofreading barcodes.

“The integration of Digimarc’s quality assurance tools directly in our platform will help our customers speed up their production process by streamlining all barcode checks,” says Reuben Malz, Founder and CEO, GlobalVision.

This integration is critical as any errors that occur when printing Digimarc Barcodes can now be caught early on to save money and time for prepress customers.

“Integrating Digimarc Verify into GlobalVision will help operators save time and also ensure the quality of their clients’ packaging, while also enabling further industry adoption of Digimarc Barcode,” says Bruce Davis, CEO, Digimarc.

Running a Digimarc Inspection

Illustration of GlobalVision Barcode inspection tool

To run a Digimarc inspection in GlobalVision’s Barcode Inspection mode, users start by loading their electronic prepress files or printed samples into the software and selecting the Digimarc Inspection mode.

The software will then run an inspection to determine if a Digimarc Barcode is indeed present and to ensure that the enhanced separation values are matching or are similar. Once completed, a comprehensive inspection report will be generated that contains the results of both the Digimarc and linear barcode inspection (if present).

Users can then save the report and share it with the customer for approval, allowing them to sign off faster and with confidence.

Digimarc Verify for GlobalVision comes as an additional tool for the Barcode Inspection mode. For more information regarding this add-on, download the Remote Barcode Inspection whitepaper.

Watch Now: How to Verify Digimarc Barcodes with GlobalVision Webinar


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Laptop uploading account and password info to cloud

Date: August, 2019 | Categoryquality Author: Ryan Szporer

“Just” backing up data isn’t enough to keep data intact anymore. While it’s a necessary step and a good start at that, a backup means little if there aren’t adequate safeguards in place to protect the integrity of the data that might have to be recovered. Even if back-ups themselves are a safeguard, they must be seen as an asset in their own right. After all, it’s estimated 100 mb of company data is worth $1 million on average. Half the firms that cannot recover lost data in 10 days cannot recover themselves.

It just makes good strategic sense to have a backup plan in the most literal sense as a result. Here are the top five strategies to keep data intact, for the sake of keeping your data integrity intact:

1. Know What to Back Up

It’s not only files that must be backed up but programs, including Operating System software as well. After all, if a newer version of a program has been released, it may not be able to read your data.

The fix simply requires that an image, or a carbon copy of all critical information including programs and their data saved into a single file, be backed up. That way no synchronization issues arise, preventing you from using the data even if you may have successfully recovered it. It would be like having the keys to the wrong car. Only this car can’t be hot-wired to run.

There is an admitted caveat: If you upgrade your hardware, the image may no longer be compatible itself. So, an alternative solution would be to just stay up to date with your program versions and continue to back up data as you normally would (i.e., thoroughly).

2. Encrypt Your Back-Ups

It almost goes without saying in this day and age, information must be kept secure for its data integrity to stay intact. One way to avoid confidential information from being compromised is to encrypt it into code, which is of course standard practice. It’s a standard practice for a reason though, namely its effectiveness. As a result, it’s significant enough in importance to rank on this list.

3. Make Regular Back-Ups

You can’t simply back up data before an upgrade. Ideally scheduled for when there is low network activity to prevent slowdown, back-ups should be made every day, with daily snapshots taken as well to monitor performance. Furthermore, at least two weeks of daily backups should be kept at any one time, as it represents a manageable time frame in case a file does get lost or corrupted.

Meanwhile, once-a-month back-ups should be preserved for one year, while annual back-ups should be kept for seven years in case a governmental request is made. In each case, consideration should also be made with regard to how much space is available, with old backups deleted to make room for new ones.

4. Store Your Back-Ups Properly

It goes beyond storing your backups in environmentally controlled facilities, even if that’s admittedly a good practice. You would also want to store your backups off-site, separately from the original data. Every good plan has redundancies built in and a backup/ data recovery plan is no different.

The reasoning is simple, as they represent contingencies in case of disaster. Imagine a worst-case scenario in which a literal natural disaster strikes. You would want as large of a chance as being able to pick up right where you left off as soon as possible. You don’t want to lose your backups and the original data all in one fell swoop. That would truly be a disaster.

5. Validate the Recovery Procedure

Validation can take many forms. With regard to the GlobalVision Quality Control Platform, for example, Installation, Operational, and Performance Qualification procedures serve to verify the application works as it should.

As the definition of validation suggests, it “provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” In the case of backups, the process in question is the recovery procedure. The back-ups themselves are the product.

Verifying the viability of the backup data is critical. Test runs ensure that, in a worst-case scenario like the one outlined in Point No. 4, the data and operations can be picked up in a reasonable amount of time, even if off-site. Restoring back-ups on a regular basis helps validate the recovery procedure. Restoring back-ups to an alternative server before so doing is actually the best practice as it validates the ability of the data to be recovered. Seeing as the data would have just been validated in a new environment, it also provides you with a backup you can be sure is viable, should you ever need to use it. Knock on wood.


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Illustration of quality control process

Date: July, 2019 | CategoryQuality Author: Ryan Szporer


When you hear the word “security,” what comes to mind? Maybe you think of the stereotypical security measures that have crept into our collective consciousness as clichés to show how hard getting into specific places can be.

I mean, when the suave James Bond smooth talks and sneaks his way into a top-secret facility, everyone watches in amazement. It turns out there’s a reason because it’s never so simple. The truth is, however many guards, walls, doors, and Closed Circuit Television (CCTV) cameras there may be, they only represent half the battle. When it comes to data integrity, half won’t suffice.

Physical vs. Logical System Security

Of course, “integrity” here refers to the state of data over its entire lifecycle, during which it must stay reliable and accurate to meet compliance requirements with regulatory bodies like the Food and Drug Administration (FDA). Those aforementioned measures meanwhile make up the physical component of security.

While physical security is undeniably important, so is logical system security, which manages access to computer systems. In fact, the two can actually complement each other in more ways than one. At least if it’s done right.

Imagine a computer system containing confidential data that can only be accessed by entering a valid username and password combination. That’s logical system security at work, at least in one form. It’s nevertheless harder to gain access to the data when there’s a locked door standing between the system and someone with malicious intent, regardless of how difficult it might be for them to simply log in to the computer were the door not there in the first place.

an illustration of a hand writing on a clip board

The Convergence of Physical and Logical System Security

However, what if cybersecurity measures were taken to lock the door instead? In that way, both types of security integrate perfectly with one another to give companies the best of both worlds when it comes to limiting system access. Of course, limited system access is one way to secure data, with at least two unique pieces of information ideally being required (two-factor authentication; username, password, etc.).

Both limited system access and the protection of the physical and logical security of systems are also two ways to help ensure data integrity.

There are undeniable barriers to integrating the two, even if the payoff would theoretically be worth it. The cost of updating systems is huge, while compatibility and communication between systems are just as big of a consideration. However, while costs do loom large, certain industries are being forced into automating and converging their physical and logical security technologies to a greater degree.

Chief among them, for example, would be the banking industry, in which corporations are being held to a greater standard with regard to how they handle client data in a post-GDPR world.

Ultimately, it comes down to whether or not corporations should invest now to update their security systems or pay for it after the fact. Penny-pinching only goes so far when the resulting grainy CCTV footage ends up being worth less than a grain of salt as far as its value in preventing security breaches, even as a mere deterrent.

That goes double for logical security measures. In today’s day and age, you need to keep up with the latest in encryption and/ or login management. The latter of which should feature a hierarchy of access levels requiring unique user ID and password combinations, like in the GlobalVision Quality Control Platform.

The Information Technology Angle to Security

Both of the above features are examples of requirements to comply with FDA regulations. However, just like software itself doesn’t ensure compliance and is only a tool used to achieve it, physical and logical security measures alone are not enough.

It takes a concerted effort on the part of a company to not only oversee the implementation of proper security protocols but enforce them to boot.

From an IT departmental perspective, enforcement implies a whole lot more than keeping up with software updates and patches. Strengthening security depends on a variety of methods available to IT professionals, including:

  • Permissions, whereby users are allowed to perform tasks in specific applications based on their responsibilities and
  • Detective controls, like anti-virus and/ or error-detection software to help improve response time when something is actually determined to be amiss.

Obviously, technology, by its very definition, is ever-changing. All the precautions and security requirements that go into protecting it and assets like data must evolve at the same time. Otherwise, however secure they might have been yesterday won’t matter.

It’s not about thinking outside the box to keep people from getting in, but keeping up on trends to make sure you and everyone else who’s been granted access stay one step ahead instead. It can get tiresome, but it beats the alternative: an unavoidable degree of uncertainty with regard to the future of your business prospects. Insecurity comes in many different forms, after all.

Related articles:

The Top Back-Up Strategies to Keep Data Integrity Intact

3 Ways Error-Detection Software Ensures Data Integrity

Monitor with data integrity checklist

Date: June, 2019 | CategoryQuality Author: Ryan Szporer

Consistency is a trademark of both validation and data integrity. In fact, without validation and the consistency for which it strives, forget data integrity. It’s like there is no data at all.

What Is Validation?

To be clear, validation is defined as, “evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.” The “consistently” is key. There is no good use for a system that cannot do what it promises every single time.

Think along the lines of a phone that only dials the right number four out of five times. Eighty percent is a good mark on a test, but not so much in case of an emergency when you need to call 9-1-1 and you get the local pizza place instead. That’s in large part why system validation is so thorough, with Installation, Operational, and Performance Qualification processes entering into the equation.

For its part, data must be consistent throughout its entire lifecycle for it to have integrity. It plays into the need for data to also be accurate, which is one of the Food and Drug Administration’s expectations for Good Manufacturing Practices. Altogether, data is expected to be “Attributable,” “Legible,” “Contemporaneous,” “Original,” and, of course, “Accurate,” or “ALCOA” for short.

Data itself can be validated too. For example, to achieve compliance with the FDA (21 CFR Part 11, specifically) in pharma and life sciences, companies must ensure integrity is maintained with regard to drug safety data as it is collected, stored, and transmitted. This is done through preliminary planning, risk identification, and testing. After the fact, everything is regularly verified as working as expected, while regular audits and reports are made to improve processes after the fact.

What Must Be Validated?

In essence, while validation is an admittedly and justifiably complex process, it boils down to that same simple premise: It all has to be verified as working as expected. Anything less and the resulting data can’t be trusted. It would be useless and just as good as if it were non-existent.

Now, confusion may admittedly arise over what exactly is being validated. In a word almost “everything.” For example, in pharma, every piece of equipment that touches or impacts the development of a drug during the manufacturing process must be validated.

While equipment validation is nothing specific to pharma and is important in other industries, IT systems and processes also qualify as requiring validation here. Even proofreading software like GlobalVision, which helps to verify packaging as being accurate but may not actually come into physical contact with the product itself, would fall into this category.

Audit trails and the like within applications are generally designed to keep excellent records. And, if they are validated as being reliable without fail, it’s safe to operate under the assumption the data they keep is as well. And, as mentioned earlier, the data must be validated too.

Data Integrity vs. Data Validation

Data integrity and data validation are two separate concepts, but they effectively have the same end goal. Data validation covers the testing and processes that lead to data complying with regulations put in place by the FDA (for example). Data integrity is what you get once it has been deemed to be secure as a result, along with several other qualifications.

In other words, much like data security is a basic tenet of data integrity and not vice versa, the same goes for data validation. If your data has been validated and/or you have proper security precautions in place, the threat of a breach or malicious attack has been mitigated. There has been no such breach with regard to data that has integrity. It has to be kept that way.

It’s similar to how a ship’s hull has integrity until it hits an iceberg. Steps are taken to avoid contact or keep water from breaching. Since there are measures in place and the ship is afloat, to begin with, it means the ship is secure. Meanwhile, validation determines how effective those measures are. If they aren’t any consistency, the ship shouldn’t have even made it out of the shipyard.

In that sense, the ship is like any other manufactured product. Only its best possible, viable version should be made available. Validation helps ensure that is the case. Consistently.


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Error detection of quality control software ensuring data integrity

Date: June, 2019 | CategoryQuality Author: Ryan Szporer


There are many ways to ensure data integrity. As automation becomes increasingly prevalent in the 21st century, software, especially on the back end, is as important as ever. Not only does it serve as the driving force behind technology in all of its incarnations, but it can also act as a fail-safe. As the term implies, “error-detection software” is one viable way to catch and stop errors that risk corrupting data in their tracks.

So, how can you ensure data integrity? We give you three ways error-detection software can help you out. 

1. Enhances Security

While data security is different than data integrity, the two go hand in hand. Like data quality, data security is a single facet of data integrity (but not vice versa). Nevertheless, without the proper degree of security, data can become compromised due to breaches, among other threats. In other words, for data to have integrity, it must first be secure.

As a result, error-detection software can be considered a key component of any complement of tools designed and implemented to enhance the security of data. Errors are simply outliers or anomalies, which are defined as observations that lie outside of norms. Error-detection software can build baselines of systems, their users, and the data they create, leading to the easy detection of behavioral deviations, whether there is malicious intent or not.

2. Reduces Human Error

There’s an inherent risk whenever you rely on human resources. There are some things a machine will likely never be able to do as well, but analyzing data is not one of them. It’s similar to the situation with manual proofreading, where, the longer the process is, the less likely errors are to get caught. Fatigue sets in eventually and the effectiveness of proofreaders declines over time.

In much the same way, the automated analysis of unstructured data saves time, thereby improving the overall efficiency of the process. Employees wouldn’t be replaced, either. There would still be a need to oversee the analysis. The right error-detection software would all the while keep all relevant parties apprised of how the data behaves. As described in Point 1 above, that’s critical.

3. Prevents Issues from Recurring

It isn’t just the errors software might catch, but the ones in the future that would otherwise slip through the cracks. Consider digital proofreading software as an example. A form of error-detection software, GlobalVision features an audit trail for compliance with FDA 21 CFR Part 11.

So, the platform doesn’t just go over the document pixel by pixel or character by character to detect graphics and text differences (among other types). The application tracks parameter changes and log-ins, so data becomes “attributable” (which is one of the five principles of data integrity). The others are “Legible,” “Contemporaneous,” “Original,” and “Accurate” (spelling ALCOA).

The End Result?

Error detection or detected differences between master and sample files from the printer can be tied to individual departments and testers. The exact origin of any error can be easily discovered and addressed. Similar errors can be prevented in the future. In that way, the number of potential mistakes gets dwindled down. Proper company quality standards get corrected and set moving forward.

As another example, a Corrective And Preventive Action (CAPA) system prevents the recurrence of product and quality problems. In manufacturing, it can become a vicious cycle of sorts. If high-quality products aren’t routinely manufactured, there is pressure to falsify data so that it passes. That leads to a lack of data integrity. So, it can be argued, a lack of data integrity is a sign of a lack of quality.

In contrast, verifying all possible data sources for the root cause of errors keeps the chances of them recurring low. From a data integrity perspective, that means fewer lapses. Product quality and customer satisfaction, whatever the industry in question, can only improve as a result.


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Cartoon computer work on the digital inspection fast and efficient comparing to manual work

Date: April, 2019 | CategoryQuality Author: Mike Malz

Regardless of the industry, all companies have the same goal in mind: to provide high-quality products to keep customers loyal and attract new ones. To accomplish this, each product must go through a strict proofreading process to ensure the accuracy of all labeling and packaging.

This can be time-consuming. As a result, some early adopters have switched to proofreading software due to time constraints. In fact, sticking with human proofreaders has proven to be a potentially costly mistake, one that may even lead to expensive recalls.

Avoid Manual Errors

Although they do their best, human proofreaders are not able to catch all errors that can be found on a label. In a North Carolina State University article about errors in food manufacturing, 25% to 50% of recalls were due to human error. There are many reasons why these errors were missed; For one, a proofreader could have been tired or simply unfocused.

With new technologies continuously introduced into every aspect of our lives, people can be distracted by an email alert or text message. When an error is detected in packaging, companies must issue a recall on their product, costing them thousands of dollars and leaving them with a ton of unsellable inventory. Fortunately, there are measures to ensure each packaging component is error-free. These measures can be combined into a single solution: an automated proofreading platform.

Proofreading That Checks Every Word

Human brains are trained to skip words. So, no matter how fluent they are in a language, they can overlook one that’s misspelled. Most people use spell-checking software such as the spellcheck feature in Microsoft Word or maybe even an online solution like Grammarly. These tools help catch those mistakes, but they do have flaws. For example, some English words are spelled differently, such as “color” and “colour.” One solution would be proofreading software that automatically detects errors in a loaded file.

Catch Discrepancies in Color

Despite evidence to the contrary, some may argue human proofreaders do catch misspelled words. Nevertheless, color differences are a different kind of animal. It’s important that the labels of packaging have a consistent color pattern. This helps promote brand awareness and identity. If the color has faded or the hue is slightly different, the product will come off as rushed. Color-detection software is one way to identify any issues before the file gets sent to the printing press.

A+ Barcode Grading

Every company wants to send out Grade “A” barcodes and nothing less, as recalls can be issued if they will not scan. And, yet, despite the very real need, human proofreaders are unable to tell if a barcode will scan properly when it reaches the customer. Leveraging technology is the only option here, and it makes sense to opt for the best solution possible. Having a process in place to digitally check barcodes saves you time and money. This is especially true when it comes to consumer goods.

Checking Labels Even After Printing

There is still a chance some errors or color differences will slip through the cracks even after the job is done and the labels are printed. The best way to review your printed files is by reverifying them, using proofreading software. This way the user can find any differences and decide to reprint if necessary.

It’s important to make sure that, even when the final label is produced, it remains error-free. It would be infinitely preferable to find errors in labels immediately after they’ve been printed instead of having a customer find them while in line at a store.

Making sure your products are high-quality extends to the packaging. Errors are not only costly but embarrassing. People are far from infallible, and companies that rely on human proofreaders risk having their products recalled and losing customers.

Making the switch to automated proofreading, like with GlobalVision, can save you time and money by sparing your firm from having to issue recalls. Businesses should consider spending a little more money now on solutions that help maintain their reputation and brand integrity. It’s not about short-term gains, but rather the long game, in which everyone is a winner.


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Man working on compliance with a laptop

Date: January, 2019 | Categoryquality Author: Ryan Szporer

In spite of the term Software Development Lifecycle (SDLC), there aren’t concrete steps to follow when coding. Each case is somewhat different, even if there is one universal truth: Certain standards apply across the board. Data integrity is one such standard.

The Ultimate Software Development Lifecycle Goal

It may not be the ultimate goal, as that would be releasing a functional piece of software. However, as a key consideration of any successful Software Development Lifecycle (SDLC), data integrity is a requirement that must not be ignored. That goes for GlobalVision’s proofreading software, which follows an SDLC approach, too.

The term “data” is relatively straightforward: information collected and potentially used by the application. “Integrity” is, of course, the end result achieved through the process of keeping that data uncorrupted and unchanged. It goes hand in hand with the concept of data security, which is sought after through the act of taking the necessary measures to protect it.

For example, individual lifecycles have proper security precautions built into them and controls added at each step. One precaution would be the act of defining early on the sensitivity of the data a given system will require. As James E. Purcell writes in his paper, “Defining and Understanding Security in the Software Development Life Cycle”, this enables the security needs of the firm to be considered come the time for decisions to be made later on in the process. Failure to do so leads to potentially unforeseen consequences and add-ons and patches after the fact. Almost by definition, those should be the last resorts.

The Software Development Process

Taking the development process one meticulous step at a time is a way to avoid them. As alluded to earlier, there is a variety that can be followed, but, generally speaking, as a list, it looks like the one below:

Analyze and Plan, which should include preliminary risk assessment. Relevant regulations that will come into play should be looked at and a plan of action as to how to address them should be devised. This should be reflected in the resulting software-requirement-specification document that comes out of these two phases.

Design, where whatever needs to be in the software gets included in the design specification document. Depending on the system being designed and compliance considerations, it may end up including failsafes with regard to the database, so it is easily backed up and restored. Furthermore, as a security precaution to protect against data being stolen or corrupted, encryption, if applicable, is identified as a necessity at this stage.

Build the Software, presumably using secure code to eliminate any potential vulnerabilities that may surface.

Test, with regard to all aspects of the software in a thorough, structured fashion. Testing is as universal as it gets and becomes a focal point of a product’s development regardless of the industry. When it comes to software though, aspects like code quality and security testing are just two of many that should be considered here, ideally by a dedicated quality-assurance team.

Unit testing, where the smallest testable parts of an application are verified for bugs and vulnerabilities independently, is also a popular pre-emptive strike against breaches but can be automated. Meanwhile, black-box testing, which places the application under the microscope of a tester who does not look at its internal workings (as if it were in a black box), seeks to test a variety of things, including external database access and the software for data-structure errors.

Deploy or Release, finally. That’s assuming all tests have passed and any security shortcomings that had been documented during the testing phase have been resolved. As part of the final quality checks of the software, further security testing may actually be done.

Maintain and Evaluate, which translates to updating the software via security upgrades and improvements whenever necessary. It turns out, sometimes there are good reasons behind those Apple iPhone updates.

Dispose, as, even in obsolescence, software must be handled with discretion. If the software is in the midst of being replaced, caution must be exercised to ensure any sensitive data is archived securely or disposed of in its entirety.

After all, any SDLC seeks to create software that is useful to the organization. Logically, software that can be superseded by a newer version has outlived that usefulness. By the same token, an application without the appropriate level of security is relatively useless, to begin with.

The Importance of Data Integrity

As a result data integrity becomes increasingly paramount, depending on the industry in which the software will be used. Expensive changes may be called for at a later date by auditors, but that’s only if the organization in question is relatively lucky.

In a worst-case scenario, hackers could find a way in, compromising not just the integrity of the data but the brand equity of the company too. That could cut any software development cycle drastically short. It doesn’t have to be that way, as the above steps show.