The Center for Devices and Radiological Health (CDRH), in cooperation with the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), is preparing to release new guidance from the FDA in late 2020 for Computer Software Assurance (CSA) for Manufacturing, Operations and Quality Systems Software. The updated guidance from the FDA will provide guidelines for streamlining documentation with a focus on critical thinking, risk management, patient and product safety, data integrity, and quality assurance.
So, the big question many life sciences companies that produce FDA-regulated products are asking themselves is this:
How can we ensure we’re aligned with the FDA’s new best practices for software validation (which the FDA is now referring to as “assurance”)?
As the FDA prepares to release its new guidance later this year, life sciences companies should take a proactive approach for transitioning their current software validation methodology to one that more closely adheres to the tenets of a Computer Software Assurance approach that focuses on quality assurance, patient and product safety, and data integrity.
As we await the FDA’s release of its updated guidance, here’s some steps life sciences companies can take now:
Why Continuous Software Validation is Important for Life Sciences Companies
Digital transformation has kicked into high gear for most life sciences companies, and in this modern era, working with cloud vendors who can support a continuous software validation framework is no longer a “nice to have” – it’s a “we must have it.”
Cloud solutions must be validated for life sciences companies to use them, and every time a cloud vendor makes an update to their software (which can be frequently), it needs to be re-validated. Unfortunately, many life science firms still conduct validation testing manually, which is time consuming and prone to error.
Continuous validation approach alleviates the pain often involved with meeting validation requirements and helps provide the path to a smooth, secure, and compliant move to the cloud. There are numerous reasons why life sciences firms should commit to a continuous validation approach:
How is it Done?
In a nutshell, here’s the continuous software validation process:
Digital transformation is proliferating in the life sciences sector as new technologies and validation approaches are delivering heightened levels of quality and assurance. Now is the time to modernize your firm’s software validation and assurance approach!
To learn more about continuous software validation, check out the xLM and AODocs How to Navigate 21 CFR Part 11 Compliance in the Cloud webinar recording, or download our infosheet, AODocs for Life Sciences Continuous Validation.