Date: October 5, 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.

Understanding the Impact of Brand Identity

Many businesses understand the basics of branding and 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.

Brand identity encompasses everything that sets one company apart from another. It’s more than products and services; it’s how a company delivers on those services. How a company meets expectations, connects with customers, 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.

The Importance of Brand Packaging in Building Brand Identity

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 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 Packaging

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.

Protection

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.

Accessibility

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 Chewy.com. A quick identifier that lets customers know exactly where a package is coming from without having to open the box.

Accuracy

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.

Building a Cohesive Packaging and Branding Identity

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 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.

Date: September 8, 2020 | Category: Quality | Author: Kayla Caticchio


Printing for the pharmaceutical industry is a complex process that requires skill, knowledge, and trust between both the printer and the pharmaceutical company. More than any other industry, there is no room for error when it comes to printing medical content like labels and cartons. Even the smallest error can be detrimental to a brand’s reputation, in some cases it can even be harmful to consumers. To be successful in printing for this highly-regulated industry, there are several steps that both the printer and pharma client must take to ensure a strong and long-lasting vendor-client relationship.

Establish proper communication

The process starts when the pharmaceutical company selects and evaluates a printer for their work. Quality, as opposed to cost, is at the forefront of the decision-making process when it comes to choosing a printer for pharmaceutical content. It is therefore essential that the appropriate KPIs, like quality, project turnover time, and system requirements are established at the very beginning to maintain the standards and expectations of the client. Pharma companies must openly communicate what they consider to be acceptable versus unacceptable in terms of deviations, giving printers an idea of their unique tolerances (for example, what stops the press). It is therefore critical that pharma companies successfully onboard new printing clients to avoid any miscommunication. Additionally, suppliers must go through several rounds of audits to ensure that they have proper capabilities before they even start to think about printing for pharma. These types of audits include verifying that files are properly saved and ensuring that they have processes in place for transporting packaging. Read Now: Top Tips for Selecting and Evaluating a Vendor

Expect to be scrutinized

So what should a printer expect when dealing with pharmaceutical clients? Simply put, they should be prepared for a much higher level of scrutiny. Putting ink on paper is not enough to successfully deliver a job in this industry. Instead, printers must ensure that they have the proper quality systems, processes, SOPs, and certifications in place that meet their client’s quality and compliance requirements. They must continuously ensure that their systems are validated, calibrated, and re-certified on a regular basis. The speed at which medical drugs must be delivered to market is another factor to keep in mind when printing for pharma. Pharmaceutical printers must be experts at balancing time-constraints while maintaining the highest levels of quality possible. Even the smallest deviation can cause delays in the process, often resulting in re-prints that end up costing the printer money. For production schedules to remain on-track, printers must keep open communication and have experience in dealing with tight deadlines.

Invest in technology

Automation technology plays a big role in helping printers get products out the door faster without sacrificing quality. By implementing a print verification system, the risk of letting a critical error slip by drops significantly. Though errors can occur anywhere in the process, the prepress stage is one of the most common areas where deviations can be introduced. Since pharma companies rely heavily on the expertise of the printer when it comes to ensuring perfect color, barcodes, and artwork, a verification system in prepress would catch any deviations between the customer-approved file and the sample. It is also important that both the client and supplier work together to ensure that the printer has the right PDFs from the beginning. Proper file creation is crucial as repeatedly playing around with a file can lead to an increased risk of introducing an error. In keeping with the strong communication aspect of pharmaceutical printing, these types of tools also allow for inspection reporting and audit trails that give the pharma company peace-of-mind and full visibility. Finally, many printers recommend having a designated middleman on the team to act as a buffer between the printer and the pharmaceutical client.

Understanding the roles and responsibilities

Though printing for such a complex industry can seem overwhelming, the benefits of establishing a successful printer-pharma partnership far outweigh the extra steps involved in managing this process. If a pharmaceutical company properly communicates its expectations while the printer invests in proper technology and quality control processes, long-term relationships can be formed. As long as both parties trust each other and understand the crucial role they play in the process, they can experience long-term growth both independently and together.

To learn more about printing for the pharmaceutical industry, check out GlobalVision’s webinar Navigating the Relationship Between Printers and Pharmaceutical Clients.

A clip board including a checklist of items
 
 

Date: June 9, 2020 | Category: Quality | Author: Michelle Wong


There are several specific factors to consider when selecting the right vendor for your business needs. It can be a daunting experience with so many vendors offering seemingly similar services. This article will help you determine what you should be looking for when selecting a vendor, and how to evaluate its performance. 

What to look for when selecting a vendor

To start your evaluation, there are four key areas to keep in mind:

1. Is their staff well-trained and kept up-to-date with industry standards?  

The vendor should be able to provide you with evidence proving their level of investment into employee training. It can be in the form of internal or external training. 

Ultimately, you need to be confident in knowing that your vendor is providing the resources necessary to keep their employees up-to-date with technical product knowledge and skills, as well as operational procedures. Employees must be able to operate the technologies competently and identify any issues.


2. Do they follow standard operating procedures (SOP) to ensure safety and security?

The vendor should have SOPs in place that define and document internal processes for each department. There should be clear accountability, such as audit trails and system logs that allow for traceability.

Employees should be following them in the exact same way every time to ensure consistency and a reduction in errors. This is especially necessary for onboarding new employees so that they are able to get up to speed quickly. 


3. Have they implemented a solid IT security policy?

Having a comprehensive IT security policy in place indicates that the vendor takes data security and privacy seriously. If you provide your company data to them, you need to know that it will be used according to the agreed purposes. 

Look for a vendor that has established practices and processes already in place to ensure data isn’t being used or accessed by unauthorized individuals or parties. Their IT security policy should include an acceptable use policy, data security policy, and data classification policy.


4. Are they able to provide quality metrics and key performance indicators (KPIs)?

If you provide the vendor with specific KPIs, they need to have a way to evaluate their metrics to ensure they hit your targets. Ask the vendor what procedures they have in place to measure their operational performance.

Check if they have an internal audit program and if it’s conducted on a regular basis. Procedures need to be routinely reviewed and adapted in order to maintain the standards you require.


How to evaluate your vendor’s performance

To ensure your vendor is providing you with the level of service and quality required, they should be successfully performing against the following factors: 

Quality control 

You need to have a full guarantee that your products are hitting the market consistently and error-free. Any errors on labels or packaging can result in expensive recalls, causing potential harm to consumers and/or damage your company brand. Vendors with quality control procedures in place are far less likely to result in such negative consequences.

Some industries are facing increasingly stringent requirements relating to product packaging, quality, and safety, so it’s absolutely essential that vendors be able to successfully meet regulatory requirements.


Project completion time 

It’s essential that your vendor conducts its operations in the most efficient way possible so your products are able to get to market according to business timelines. A failure to manage time and project management effectively will potentially result in delayed production.

In addition to having SOPs in place, a way for your vendor to speed up production output while reducing quality issues is by using a quality inspection system. This reduces the need for manual proofreading and visual inspection, which is at high risk for introducing errors and rework. 


Innovation and technology 

Your vendor should have top-of-the-line technology and be leaders in innovation. Evidence of this includes practicing continuous improvement and implementation of new innovations to stay competitive. Innovation in packaging design can take many forms, including introducing new technology, changes to the supply chain, and product and process improvements.

By investing in its own business, your vendor is demonstrating their commitment to providing you with the best product and service, which, in the end, benefits your customers. Your vendor will be able to better serve your needs when it comes to faster turnaround times, reduced waste levels, improved product quality, and providing a wider product range.


Tracking and reporting 

All vendor activities related to your business need to be transparent. You should be able to measure and monitor their performance, and they should be able to access the information required for operations. Inspection reports should be easily accessible and communicated between both parties. This includes automated performance tracking and access to a full audit trail if requested. 

Measurement can also go beyond the basic aspects of quality, delivery, and cost. Also, consider measuring the overall success of the relationship you have with your vendor and their level of accountability and responsiveness.


Evaluating your vendor saves you time and money

Doing your due diligence in selecting the right vendor and conducting a thorough evaluation of their performance is critical in achieving high-quality servicing and production. By selecting a competitive vendor that has strong quality control measures, effective project management, and invests in new technologies, you are creating a partnership that will support the long-term success of your business. 

Not only are you ensuring that your packaging is created efficiently and correctly, but benefits also include saved time and costs, which then transfer to your customers and create a better experience with your brand.

illustration of different packaging

Date: May 19, 2020 | Category: Quality | Author: 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. 

A Non-Linear Process

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 as an aid

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

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 along 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

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 are 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 creation and management 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 what affects 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.

 

Date: August 22, 2019 | Category: Quality | Author: Ryan Szporer


When it comes to automation, 4D stands for something other than four dimensions. The benefits of going digital instead of sticking to manual processes can be just as impressive, especially with regard to updating your proofreading process and introducing a digital platform into your workflow.

The Pitfalls of Dirty, Dangerous, and Dull Work

The first three Ds instead stand for “Dirty,” “Dangerous,” “Dull”. The acronym implies automated solutions can add value to tasks previously completed using manual labor, in large part because workers may not want to do them. To at least a certain extent, it’s accurate. This may include jobs like mine exploration (dirty), delivering pizza (dangerous), or being a teller behind the counter at a bank (dull).

With specific regard to the latter, Automated Teller Machines (ATMs) are commonplace and serve as proof that robotics can make companies more profitable without sacrificing employees’ jobs. The number of ATMs and human tellers in the United States have both increased since the former were first installed. ATMs have allowed banks to open more branches, leading to more positions and actual bank tellers, with their job descriptions evolving in the process.

A recent series of essays from the Vancouver-based Fraser Institute, a self-proclaimed independent think tank, argues much the same thing: “While automation, artificial intelligence, and robotization will eliminate or change the nature of some jobs, these technologies will also create many new jobs at a time when [the retirement of baby boomers] will reduce the labor force as a share of the population,” says one of the essay’s author’s, Steven Globerman.

Digital vs. Manual Proofreading

In any case, on the subject of tedious tasks, proofreading has been proven to be more effective when it’s done digitally instead of when manual labor is used. Inspection results must still be verified by someone in the quality control department in question. However, whereas avoidable errors slipped through the cracks before due to inevitable drawbacks like proofing fatigue, now a digital system is ideally put in place and made responsible for running the actual inspections.

The platform in question, like GlobalVision, would draw attention to potential issues when comparing master and sample files. A quality control technician then determines which differences must be addressed before the hypothetical print job is finalized. It may sound like an additional step, but when digitally proofing a single leaflet takes mere seconds instead of hours, the time savings after having moved to a digital solution cannot be denied. Combined with the heightened accuracy, packaging gets to market faster, still in pristine condition.

In fact, automation has been proven to reduce human error by as much as 50%, improving overall efficiency by 75%. Speaking of which, the fourth “D” has been said to stand for “Delicate.” It remains relevant to proofreading, with lost lab samples due to human error being estimated as costing $20,000 in losses over a four-month period.

Preserving Your Brand Through Effective Quality Control

Printing samples are similar, as they must be handled with care. When all is said and done, they amount to product packaging in the hands of consumers, after all. If there’s little debate that typos and errors, in general, must be weeded out before that point to preserve brand integrity, the same argument holds true for the overall condition of the packaging. Automation is less of a wild card in that context and is a better bet to keep shipments from the printer in good shape.

In the end, proofreading manually isn’t necessarily a job no one wants to do, but it is one that has its fair share of pitfalls. It’s dull and delicate and even dangerous, in the sense that one wrong typo can lead to serious health consequences for consumers if they get the wrong dosage information on their medication. The fourth “D” in the case? Just “Digital”.

Going digital helps eliminates all those concerns, enabling companies to focus more attention and resources on developing the product itself. After all, it’s what’s inside the packaging that keeps customers coming back. All (hopefully pristine) packaging does is hook them to start.

“Just” backing up data isn’t enough anymore. While it’s a necessary step and a good start at that, a back-up 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 who cannot recover lost data in 10 days cannot recover themselves.

It just makes good strategic sense to have a back-up plan in the most literal sense as a result. Here are the top five strategies to make it happen, 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 relatively 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, but 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 back-ups 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 back-ups deleted to make room for new ones.

4. Store Your Back-Ups Properly

It goes beyond storing your back-ups in environmentally controlled facilities, even if that’s admittedly a good practice. You would also want to store your back-ups off-site, separately from the original data. Every good plan has redundancies built in and a back-up/ 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 back-ups 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 back-ups, the process in question is the recovery procedure. The back-ups themselves are the product.

Verifying the viability of the back-up 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 back-up you can be sure is viable, should you ever need to use it. Knock on wood.

 

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.

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 pay-off 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 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.

Technology continues to advance at breakneck speeds. Whatever your industry, there are definite advantages to riding the wave, even if only to keep pace with everyone else. That includes the often-forgotten quality-control sector, which can be very competitive.

That’s not just in reference to external competition among fellow solutions providers, but internally as well. There’s always going to be the pressure to improve upon set processes for greater error-finding efficiency. It only makes sense then to embrace automation, which has proven incredibly beneficial in that respect, especially when it comes to proofreading solutions.

Here are a few of the top benefits:

Prevent Avoidable Errors

One misconception revolving around automated solutions is they only serve to replace workers. That’s not necessarily true relative to digital proofreading solutions.

In fact, generally speaking, automation can actually help employees. With specific regard to proofreading, it makes employees’ jobs easier, preventing proofing fatigue and avoidable errors from slipping through the cracks. It’s been proven that manual proofreading is simply less effective and shifting gears to an automated solution is an obvious choice. With fewer errors, less pressure is put on employees to consistently perform “above their heads.”

Truth be told, a company is financially healthier and in a better position to keep more workers the fewer errors that result in costly recalls. Automation lets companies allocate human resources to other departments in greater need. And, contrary to popular belief, there will always be a need for technicians to physically check automated inspection results, even if they’re not the ones performing the actual inspections. Put another way, workers control the helping hand digital solutions lend to the overall operation, at least in this case.

Instant Detection and Verification

Companies can shave time off their manual proofreading processes to a greater extent through the sheer convenience of an all-in-one solution. High-quality digital proofreading platforms don’t just look for typos. However expensive one small misplaced decimal point can end up being for the company in question, the right application can pay for itself in other ways too.

A system like GlobalVision offers inspection modes for artwork, color, barcodes, and Braille (in addition to text). Regarding barcodes and Braille regions, the system instantly recognizes each one to be graded or translated/ compared. There’s no need to select anything except the desired mode unless it’s to conduct a partial inspection on a specific portion of the loaded files.

In the case of graphics, you can similarly choose a shape for extraction on the loaded Master instead of opting to inspect the entire file. This just serves to instruct the application to automatically locate all the repeats on a sample press sheet (for example). The benefit here far outweighs any additional steps that need to be taken.

Ultimately, inspections go much smoother and faster, with up to five different types able to be run at once in a matter of seconds or minutes instead of hours or days… a fraction of the time it takes to proof the same materials manually… more effectively too.

Get to Market Faster

Not only does a digital proofing platform translate into error-free packaging on store shelves and artwork files in general. Fewer mistakes also mean fewer revision cycles, which translates into an accelerated time to market and bigger bottom line. That’s in addition to the money saved implementing a quality-control system that’s more efficient and the recalls that will be avoided as a result. Going digital pays for itself over time.

If it’s not the improved speed at which you get to market, it’s the improved speed at which inspections are run and errors get detected. Adding an automated element, such as a digital proofreading platform, to your quality-control process means keeping pace with technological change and competitors alike. That’s undeniable, but it’s the internal performance improvements that make automation a trend that should not and cannot be avoided. Much like the errors the right system so effortlessly and inevitably detects.

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 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 with 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.

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, 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. This is how:

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? 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.