Closing IT Gaps to Achieve Audit Readiness
Brevitas executed a risk-based GMP IT audit readiness assessment across a regulated vaccine and biologics environment. The engagement focused on identifying control weaknesses across infrastructure, validation, and data integrity while aligning systems to Health Canada, 21 CFR Part 11, and EU EudraLex Annex 11 expectations.
The team assessed end-to-end IT architecture across network, compute, storage, and platform services to establish a defensible compliance baseline and inspection-ready state.
Business Challenge
A global vaccine and biologics manufacturer required an independent assessment of IT controls supporting high-stakes manufacturing and cold-chain storage. Operating within a complex regulatory landscape governed by Health Canada, the US FDA, and EU EudraLex, the environment spanned multiple frameworks relying on a hybrid infrastructure combining on-premises data centers and cloud platforms. This complexity required the client to identify critical non-conformances across their IT landscape and define a focused, risk-based path to inspection readiness. Additionally, the client required a structured remediation strategy supported by technical evidence and aligned with regulatory expectations.
Our Approach
To perform a risk-based GMP IT audit-readiness assessment across governance, infrastructure, validation, and data integrity, the Brevitas team:
- Reviewed quality and governance controls, including QMS, SOPs, supplier oversight, and training records.
- Assessed data lifecycle controls, with a focus on governance, disaster recovery, and business continuity.
- Evaluated IT infrastructure for GxP compliance across network, server, and platform environments.
- Reviewed computerized systems lifecycle controls, including CSV, CSA, change control, and periodic review.
- Conducted on-site walkthroughs, SME interviews, and risk-based reviews of validation packages to verify end-to-end data integrity.
Results Achieved
- Identified high-priority regulatory risks and data integrity gaps across 6 control domains, including security and environmental controls, operations and maintenance, configuration and change management, incident and problem management, backup and disaster recovery, and infrastructure qualification.
- Delivered a prioritized remediation roadmap aligned to risk and operational impact, establishing a clear path toward improved data integrity, enhanced traceability, and more resilient IT controls.
- Advanced readiness for upcoming US FDA and EU Eudralex inspections.
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