Lab lifecycle management: 420+ systems
We managed end-to-end lifecycle services at a leading biologics hub, supporting 420+ lab systems with full GxP oversight, data integrity remediation, and seamless lab continuity.
Case study higlight
Case study highlight
Key outcomes
- 700+ systems assessed across global sites.
- 50+ equipment families evaluated and classified.
- 135+ SOPs, protocols, and system docs revised.
- Enterprise-wide access controls and audit trail standards implemented.
- Elevated inspection readiness and regulatory compliance.
- Powered by cross-functional collaboration between QA, validation, and automation teams.
Challenge overview
Background:
A global CDMO needed to address widespread data integrity risks tied to obsolete software, inconsistent access management, and lack of audit trail controls across hundreds of systems.
Key challenges:
- Fragmented system documentation and validation practices.
- Lack of standardized audit trail, backup, and access controls.
- Increased regulatory scrutiny across US and EU sites.
- No consistent governance model for ongoing data integrity.
Our approach
System inventory & risk classification
- Evaluated 700+ systems and categorized by equipment family.
- Used GAMP 5 risk-based methodology to prioritize remediation.
Cross-functional collaboration
- Partnered with SMEs, IT, QA, and operations teams.
- Developed 50+ detailed data lifecycle flow diagrams.
Technical & procedural review
- Reviewed SOPs, access management, audit trail capabilities, backup/restore processes.
- Assessed gaps in validation, documentation, and electronic records compliance.
Governance & remediation
- Updated 135+ procedural documents and protocols.
- Implemented enterprise-wide policies for audit trail, access, and system validation.
- Established sustainable governance framework for ongoing compliance.
Results & measurable impact
As life sciences companies grow and digitize, fragmented data practices can introduce massive regulatory risk. This case shows how Pinnaql helps organizations take control of system-level compliance, implement sustainable data governance, and stay audit-ready across global operations.
Key results
- 700+ systems brought under a standardized, inspection-ready DI framework.
- Eliminated regulatory risk from outdated practices.
- Strengthened compliance posture across global manufacturing and lab operations.
- Created a scalable model for future system onboarding and validation.
- Improved confidence during internal and external audits.
- Avoided costly remediation efforts and regulatory citations (483s, warning letters)
