The number of recalls is growing. Over 50% of those recalls are related to the labeling or to the packaging artwork. Over 60% of all recalls are caused by human error.
A lack of an established process within the business is often cited as a source of errors. No wonder then, that these companies are looking for fail-safe solutions: software that can help them maintain GMP packaging and labeling guidelines.
Most companies strive to be Good Manufacturing Practice (GMP) compliant. GMP is a system that ensures that products and packaging are consistently produced and controlled according to a certain level of quality. With GMP, there must be written procedures and systems in place for every step of the manufacturing process for each product. GMP compliance helps minimize the risks in Pharma and Life Science product packaging and is widely accepted as the best way to conduct business.
Good manufacturing practices for pharmaceuticals require that highly regulated companies use software that is validatable (often referred to as ‘GMP compliant’), specifically against regulations set out by the FDA governing electronic systems known as 21 CFR Part 11 and the European Commission’s Annex 11 guidelines.
An audit trail is an essential part of any brand’s packaging — especially for those in the Life Science and Pharma industries. An audit trail is a way to make all electronic data traceable across the entire packaging process. An audit trail shows a record of who accessed the packaging project, as well as the date and time they accessed it. Under 21 CRF part 11, an audit trail must be protected and accurate should only be accessible by authorized personal only and should record the date and time of entries and actions, as well as modifications and deletions of records in the system. EU Annex 11 also requires that any relevant changes or deletions be tracked and monitored regularly.
In addition to being needed to remain compliant with those regulations, an audit trail can also help you improve your packaging process.
In regards to your packaging, you should always be on the lookout for inefficiencies and preventable errors. With these errors comes a laundry list of repercussions, including recalls, broken trust and declining loyalty with your consumers, as well as a negative brand image. Not to mention it can take up to 180 days to make packaging change — which will cost your business time, effort, and money.
For brands operating in the Life Science and Pharma industries, making sure your packaging has the correct information is mission-critical. Otherwise, you may be looking at big fines from the Food and Drug Administration (FDA).
But, but turning to your audit trail, you will be able to determine who touched each part of the process, when changes were made, and when changes were approved.
In this post, we’ll break down how exactly an audit trail can help you with your packaging.
Ensure User Accountability
Hopefully, you’ve surrounded yourself with a team that you trust. However, that doesn’t mean that the occasional slip-up doesn’t happen.
Using an audit trail allows you to go back and find the source of an error (like a grammatical error or typo on a package), you can trace the mistake to the root cause.
An audit trail essentially adds a level of accountability to your overall packaging process and its’ presence will help your team be extra diligent when making revisions to the label and artwork files.
Catching an issue is one thing, but being able to reverse the errors is another way to leverage your audit trail to improve your packaging process.
Packaging management software saves older versions of a nutritional facts table or label and artwork file, regardless of what type of change was made. So, if you ever do happen upon an issue, you’ll not only be able to identify where the issue occurred, but you can also easily reverse the error.
Use WebCenter For Your Packaging Management Needs
Packaging is more complicated than ever, with everything from logos and colors to ingredients and dosage guidelines needing to be accurate. As a result, having a packaging management solution you can rely on day in and day out is a must.
Any software solution provided to a company in these industries must be GMP validatable, specifically ERES (Electronic Records, Electronic Signatures) regulations, and the vendor must be able to demonstrate that the software has been developed to contain all the necessary technical controls to ensure it meets these requirements.
If you’re looking to streamline your packaging review and approval process, reduce the number of errors, and increase the overall speed-to-market of your products, WebCenter is the solution for you.
Specifically, in terms of GMP packaging and labeling requirements, Esko WebCenter has been developed according to GAMP5 (Good Automated Manufacturing Practices) guidelines with all the necessary technical controls in place to ensure it is fully validatable.