The phrase, “You’re getting audited” causes stress no matter what business you’re in. But even in the Life Sciences, where audits are just part of everyday life, it can cause extreme amounts of stress. The work that needs to go into prepping for an audit differentiates the Life Sciences. Even internal audits require a mountain of work when you have a legacy or paper-based system. Rounding up the key players and finding out what they did with the paperwork or where they saved something in the system is a monumental headache! That is where audit management comes in.
Your QMS should Shrink the Audit Management Burden, not Enlarge It.
Ready to use QMS solutions help both large and small life science manufacturers simplify and organize the entire audit management process. They allow manufacturers to prepare for and conduct audits and implement internal/external audit directives and observations correctly.
- Eliminating paper trails with an “audit ready” anytime, anywhere electronic solution
- Streamlining scheduling, tasks, and audit documentation
- Facilitating regulatory compliance
- Easily establishing audit processes for the entire organization and 3rd parties
As those of you in the Medical Device world may know, ISO 13485 represents an essential level of standardization and certification for QMS in the medical device manufacturing industry. It stipulates the requirements needed With the right QMS, a medical organization can track, maintain, and even improve processes related to applicable audits and regulations.
So, for example, in Section Four of the regulations, you should include general QMS expectations, requirements, and documentation in your process. With a cloud- based QMS, a company can include and maintain requirements for the quality manual, medical device files, control of documents, and control records so that everyone who needs it can access it in an instant from almost anywhere.
Or, in Section Seven where Product Realization is the focus, your ready-to-use QMS can have at the ready every aspect of a product’s life cycle from details about the planning phases all the way to the with delivery and servicing. Allowing you to automate notifications and grant access to all essential parties so that no event in the product’s life cycle is lost.
An ISO 13485 audit helps determine the status and health of your current QMS and processes. The purpose of an audit is to ensure that manufacturing, product development, and other related processes meet current good manufacturing processes (GMP), as well as conform to the commitments of ISO 13485. Having these safeguards and processes in place in a reliable and easily manageable system can revolutionize a medical device manufacturer’s workflow. You can achieve more with improved workflow, save money , and make product deliveries more effective. And that was just one example.
In Pharma, cGMP is the standard the FDA uses to monitor drug manufacturing. A ready to use QMS allows you to ensure that you are not only meeting but exceeding cGMP standards. You can do this by organizing all the data around the manufacturing process in an optimal way for FDA submission and review. This leverages your QMS for audit management.
This comes in handy specifically when talking about PART 314. In part 314 the requirements and guidelines are set forth by the FDA for procedures and requirements for submissions for new drugs.
With a ready-to-use QMS you can organize any and all new drugs by any number of requirements. So if you are releasing a new pediatric drug and need information organized for that specific drug to comply to section 314.55, the way you’ve organized information for other drugs that don’t have a pediatric use but are being petitioned as a change from a currently listed drug covered in section 314.93 won’t won’t impact it.
With the cGMP being incredibly flexible for each company’s specific needs, as discussed here, it is essential that your QMS can be just as flexible. This ensures you have all the information you need accessible when you need it.
We can apply the same principles to all the other Life Science industries with similar results and consistency. That is the beauty of the ready-to-use QMS system. It is, as stated, ready-to-use. Whether you are in Pharma, Biotech, MedTech, or Medicinal Cannabis, there are auditing regulations that must be met and those can be greatly simplified with the right QMS.
All in all, these kinds of automations and accountability features ensure that the auditing process is no longer a stress mine field of “did we’s or didn’t we’s.” Every aspect and feature auditors care about can be tracked, monitored, and verified with ease and efficiency. Getting a powerful modern cloud-based QMS takes all the power out of the phrase, “You’re getting audited” by empowering your audit management capabilities.
If you want to learn more about how a Ready-To-Use QMS can dramatically shape and improve the speed of your business, download our most recent eBook, The Need for Speed. It takes a deeper dive into how a Ready-To-Use QMS differs from a standard legacy or paper-based solution.