Date: July 28, 2020 | Category: Quality | Author: Kayla Caticchio


Now more than ever, the demand for safe and effective medical drugs is increasing on a global scale. This means that regulatory affairs teams are working overtime to interpret, apply, and communicate the guidelines received from governing bodies like the FDA and EMA when it comes to developing new drugs. And when medical drugs are approved, they must then be made available for use on a global scale. As a result, all content must be adapted to meet the legal and cultural requirements of markets beyond the country in which they were produced.

As market sizes expand, pharma companies must coordinate localization for every product they release. More than just translations, this includes adjusting elements like color, date formats, units of measurement, and artwork to reflect various markets. All content like leaflets, cartons, inserts, and legal documentation must also be fully adapted, creating challenges for regulatory teams when combined with the speed in which products must be released.

Technology for the pharmaceutical workflow

A key way to effectively manage the increasing workloads as a result of globalization is to harness technology that allows regulatory affairs teams to operate at scale. When it comes to proofreading, manual processes are no longer efficient given the speed and complexity in which products must be delivered.

With a digital quality control system, proofreaders and RA teams can verify content accuracy on digital files and printed packaging components, eliminating inefficiencies at every stage of the pharmaceutical workflow. To begin, product requirements are submitted to regulatory bodies who then compile the information into briefing documents. At this stage, a digital quality control system would ensure that all copy documents are error-free and accurate for internal revisions.

At the artwork creation stage, artwork files can be automatically inspected to make sure that no errors were introduced during the file creation process. Examples of errors that could be created during this stage include logo errors, incorrect product information, and barcode defects. At the final stage, a digital quality control software can automatically compare approved files to supplier proofs before going to print, ensuring that products make it to market with packaging that is entirely error-free.

Foreign languages & data compliance

Managing content in foreign languages is another challenge for regulatory teams in the pharmaceutical industry. As medical products make their way into foreign markets, all materials and content must be properly translated into multiple languages which creates significant room for error. Technology solutions can help effectively manage this by improving document management, version control, and quality assurance through automated proofreading that supports many foreign languages. 

Along with accurate foreign translations, following compliance and data integrity guidelines is essential in the pharmaceutical industry. Digital quality control tools utilize audit trails and reporting features to track all activities, ensuring compliance with bodies like ISO certifications, 21 CFR Part 11, and Annex 11. These tools help protect data integrity by providing full traceability on who ran an inspection, the inspection results, and what changes need to be made.

As the nature of regulatory standards continues to evolve, so does the need to effectively implement technology solutions like automated quality control. These technology solutions not only improve processes between teams, but they also increase cross-functional collaboration and give pharmaceutical companies the tools they need to operate on a global scale.

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

 
 

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.

Date: May 4, 2020 | Category: Proofreading | Author: Kayla Caticchio


Once upon a time, in a land far far away (well, in the midwestern USA), there was a printer who was anxiously awaiting the final decision of a potential client. If things went well, this would be their biggest deal to date. But the days went on and on until they finally received the long-awaited email. “We’ve decided to go with someone else” the email read. How could this happen? they asked themselves. “Although we were impressed with your facilities, we feel as though your methods of quality control are not at the level we would like ” the email continued. “We’ve experienced recalls in the past and we just can’t risk them”. 

Unfortunately, situations like this are not uncommon in today’s supplier landscape. As competition between brands increase, so does the demand for high-quality labels and packaging. This means that companies are expanding their requirements when it comes to selecting suppliers or manufacturers for their jobs. Aside from the obvious requirements like cost and turnaround time, many companies look for the added assurance that extensive quality checks are being conducted in the production facility.

We’ve highlighted 3 ways suppliers can use automation to secure customers:

1. Show them you care about their quality 

Having an extra layer of security goes a long way when it comes to quality control. By implementing a secure and verified quality system, you’re showing potential clients that you’re willing to invest in technology that helps ensure that their products are of a high standard. You’re also helping them uphold their reputation and brand integrity by helping them get their products to market without any errors. In fact, we’ve had GlobalVision customers tell us that having a revision system in place has helped them gain customers just by having it visible on their production floor. Having a reliable quality system, like GlobalVision, in place provides peace-of-mind that the supplier can be trusted to produce the best products.

2. Reduce the risk of costly errors 

With digital proofreading, suppliers gain a competitive advantage due to the fact that their content is less likely to have errors than competitors who rely on manual proofreading. The customers appreciate the extra sense of security in knowing that their labels and packaging are accurate, potentially saving them from costly and detrimental recalls. For a printer, as an example, even one missed error can cost them a customer, especially if the error goes public or ends up costing their client a lot of money. Prior to using GlobalVision, a customer had lost tens of thousands of dollars by accidentally producing batches of products that were missing their client’s logo.

3. Use it as a unique marketing and sales tool

More and more, we’re finding that suppliers are using their automated proofreading systems as a marketing and selling point. Today, brands are placing ever-growing importance on automation, integration, and innovation. They’re therefore looking for suppliers who’re also leading the charge when it comes to implementing modern technology in their production process. By showing potential customers that they’re willing to innovate to meet the demands of their customer base, they’re opening doors for new business opportunities from industries they otherwise wouldn’t have broken into. In fact, one of GlobalVision’s printer customers was able to land a $2 million dollar deal by having an automated quality control process in place. Their commitment to high-quality production set them apart from the competition and made them the obvious choice.

Acquiring customers with today’s level of competition is no easy affair. It’s imperative that suppliers continue to ride the technology wave and make use of the automation tools that are available to them, especially when it comes to quality control. By doing so, they’ll be able to increase their customer base and ensure continuous growth that stands the test of time.

To learn more about acquiring customers through automation, check out GlobalVision’s Guide: How Automated Quality Control Helps Printers Secure Customers

Date: April 21, 2020 | Category: Company | Author: Kayla Caticchio


A special note from Reuben Malz, Founder and CEO of GlobalVision

Not everything is broken

It’s during times like these that we must look at our situation from all perspectives.

Just because everything looks dark, doesn’t mean that there is an absence of light.

Yes, many things we took for granted in our personal and working lives have come to an abrupt halt. Even our freedoms have been reduced.

However, not everything is broken. 

The supply of energy like gas for your car and electricity for your home has never been interrupted. The internet, cloud, and Netflix are working, but maybe a little slower. Cell phones. Facetime, Facebook, and Twitter still work. The food supply chain is intact. Farmers are working, greenhouses are growing vegetables, and soon seeds for the fields will be planted. In short order, all the store shelves will be replenished after the buying frenzy abates. The sun still rises and sets every day. 

Not everything is broken, but change is occurring at lightspeed. We have no choice but to give in and adapt to it. The office, the plant, the conference room, trade shows, and meetings have become uprooted and relocated – to your house. 

Services and products still need to be delivered as consumption continues. The way it’s done has just gone remote.

We must be grateful that technology is sufficiently advanced for us to jump tracks. These technologies are what allows us to work from home and ensure that services and products are being delivered.

I remember a time when the internet was born and many companies didn’t trust it with their corporate assets. Everything remained in hardcopy form for many years. It was believed that anything on the world wide web was visible to the world. We think back and laugh. It seems so silly now.

Now, we’re moving to the cloud and working remotely for the first time. We’re still in the early days, but working, schooling, and entertainment is on a rapid evolutionary track. Yes, it was happening anyway, but the world has been forever changed. 

When we arise from this chaos, everything will have changed. But not everything will be broken.

Welcome to the cloud, earthlings!

Reuben Malz

April 2020


Remote work tips from our kitchen table to yours

There’s something comforting about Reuben’s message in a time when the world is noisier than ever. His message reminds us to cut through the noise and focus on the potential for growth and evolution in the midst of a worldwide standstill. Though it may not seem like it, these unprecedented times have created an opportunity to use social isolation to our advantage. Beyond Netflix-binging and the endless DIY projects we’ve been putting off, this time can be utilized by stepping back and benefiting from more focused work.

The team here at GlobalVision has put together 5 of our best tips to help stay productive and make the most out of remote work.

1. Use this time to evaluate your current strategy

From product planning to long-term strategy building, being away from the hustle and bustle of the office can create a quiet environment to focus on your team and company growth. With the world changing the way it does business across all industries, now is the perfect time to start planning how you’re going to implement the changes you’ve been thinking about. Maybe it’s dreaming up a new product feature, or implementing a quality control software, using this pause in time to plan for the future is never a bad idea.



2. Use technology to stay connected

At GlobalVision, we pride ourselves on being collaborative in many ways. Every product, new feature, and piece of content we put out into the world has touched multiple departments within our walls. And it’s no different when it comes to our digital walls. We’re lucky to be in an age where technology is so available to help us with our daily tasks. There are tons of great softwares out there to help facilitate communication between team members and departments. Our favorites include Slack, ZOOM, and Google Hangouts (especially for those after-work virtual cocktail hours). We also suggest a collaborative database like Airtable to help keep track of projects and eliminate any blockers in the workflow. These platforms provide project visibility and make it easier to collaborate with others. Bonus – they’re also great for sharing memes and pictures of your pets.

3. Continue with (or introduce) team meetings

Team meetings (virtual of course) are a great way to highlight key areas of focus for the week ahead. The frequency of these meetings depends on your team’s unique needs, but the majority of us at GlobalVision find that having a check-in every week or every few days helps everyone stay on track. Team meetings also allow each member to pinpoint personal goals while keeping track of how everyone is progressing with their projects. They’re a great way to give feedback and boost morale by encouraging others. If standup meetings aren’t something you’re used to, remote work might be a great time to test them out! 



4. Stick to a routine

Creating a ‘work-from-home’ routine is a key factor in ensuring productivity while away from the office. Since the morning commute now consists of moving from the bed to the kitchen table, there’s no more sitting in traffic each morning mentally preparing yourself for the day ahead. We find that diving into your to-do list early in the morning helps the mind wake up and puts us into a work-based mindset. By structuring your day down to the last task, you’re fully committing yourself to your projects while minimizing distractions. Be sure to schedule some break time as well.

5. Take regular breaks

Our final tip is to take regular breaks that allow you to reset and refocus your mind. Have lunch and coffee breaks away from your computer, and schedule some time to call or video chat a friend. Give your colleagues clear indications of when you are and aren’t available to answer messages and emails (and be sure to respect their availability as well). There’s nothing wrong with snoozing message notifications for a while if you need some time to recharge. Finally, we suggest letting others know your preferred method of communication, whether it be instant messaging, email or phone calls. This helps avoid the frustration of not having messages replied to in a timely manner.

We hope these tips have given you some inspiration on making the best out of this remote work situation. We encourage you to not lose sight of accountability and motivation even when times are tough. The human ability to adapt to new situations is incredibly important in times of crisis. Use this time to lock in a vision and direction for your team and company, and make sure you use all the tools at your disposal to communicate these goals thoroughly.

During this time, GlobalVision is committed to helping our customers account for the surge in remote work. For more information regarding our 60-day free license offer, contact us here.