Pharma and medical devices labeling? We can help!
Why is quality assurance so important?
Across life sciences, the practice of label validation has become vital, as both the United States Food and Drug Administration (FDA) and the European Union’s regulators increasingly require electronic validation of pharmaceutical and medical device labeling solutions to maximize safety and security. Due to the heightened focus on validation, pharmaceutical and medical device manufacturers who do not use validated software, especially those who still rely on manual or paper-based processes, are placing themselves at increasing risk.
At their best, validation processes allow companies to demonstrate when, where and by whom a label was originated and printed, providing more detailed and searchable records, thereby assisting with future audits and regulatory compliance.
Why validate?
In addition to enabling life sciences companies to meet regulatory requirements, validation offers multiple advantages:
How to incorporate validation processes when implementing a label management system
As part of the process of implementing a new global labeling system, pharmaceutical and medical device companies should draw up a validation master plan, with policies and procedures which rest upon objective evidence.
Part of this should be a supplier audit, to ensure that computer systems are compliant with relevant regulations, alongside a risk assessment, test strategy, good document standards, and training protocols. It’s even more important that a company’s labeling systems’ rationale can stand up to the scrutiny of an audit.
Even once a new labeling system has gone live, the process of validation needs to continue, so that a state of control is maintained into the future. Patches may need to be applied to the system for example, with a consequent need for validation. Finally, be sure to document all validation; regulatory bodies may require this.
Altogether, validation performs a crucial function throughout the implementation of any new global labeling system, with major advantages in cost saving, efficiency gains, and regulatory compliance.
Blog post where originally found here: https://www.nicelabel.com/blog/2017-03-21/label-validation-life-sciences/
(Altough it seems they renamed it or archived it I will keep it here for reference)
Read this article to dive into why validation of the medical device labeling si so important
Compare before you approve
We can help you with the labeling part of the compliance, in cloudlabel you invite your co-workers, suppliers, and partners to all be a part of the approval process of your labels. A centralized system that makes it easy to create and maintain a verified labeling solution.
Make it easier to find pending changes
It’s the details that sometimes make the difference, and they are sometimes hard to identify. That’s why we created this comparison view that highlights the differences for you to easily find them.
A powerful tool that saves a lot of time and frustration
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