The FDA has issued final guidance on “Computer Software Assurance for Production and Quality System Software” that modernizes how manufacturers validate software used in GxP operations. The shift from traditional software validation to risk-based computer software assurance offers manufacturers more flexibility while maintaining regulatory compliance – but it also clarifies what regulators expect from your software vendors.
The guidance explicitly addresses cloud computing (IaaS, PaaS, and SaaS) and emphasizes that manufacturers can leverage validation work already performed by their vendors. However, this isn’t a free pass – the FDA recommends thorough vendor assessments, including review of software development lifecycles, quality management systems, cybersecurity practices, and data integrity capabilities. For software directly used to maintain quality records, the requirements remain stringent: audit trails, metadata, secure data storage and transfer, and validated migration procedures must all be demonstrated.
GXP-Storage® operates at the intersection of these requirements. Our GXP-Guardian® platform was designed with 21 CFR Part 11 and data integrity principles embedded from the ground up, not retrofitted. We maintain comprehensive vendor qualification packages that clients can leverage in their risk-based assessments – including our software development practices, ISO 9001 and 20387 certifications, and validated data migration procedures. When you store quality records or biological materials with GXP-Storage, you’re not just renting freezer space – you’re partnering with a vendor whose systems have been validated to support your regulatory obligations.
As the FDA guidance makes clear, the rigor of your vendor assessment should match the criticality of the function. For long-term storage of materials and records that support product quality and patient safety, shouldn’t that assessment be thorough?
Contributed by: Kate Peters, Director, Quality Assurance
About GXP-Storage
GXP-Storage is the trusted partner for regulated material management in life sciences. Combining purpose-built facilities with the validated GXP-Guardian® digital platform, the company delivers total custody, real-time visibility and audit-proven compliance across every temperature—from controlled ambient to cryogenic. Trusted by global pharma, biotech, CDMO and healthcare organizations, GXP-Storage transforms storage from a compliance risk into a strategic advantage.
Learn more at gxp-storage.com