Data integrity transformation: 700+ global systems
Pinnaql partnered with a top 10 global CDMO to assess, remediate, and standardize data integrity practices across laboratory and manufacturing systems—avoiding costly 483s and elevating compliance.
Case study higlight
Case study highlight
Key outcomes
- 420+ lab systems supported under full GxP lifecycle management.
- 100+ CSV projects completed across complex instrumentation.
- 60+ GMP chamber relocations & requalifications.
- Maintained zero 483s and regulatory citations.
- Embedded team seamlessly integrated with scientists and vendors.
- Enhanced data integrity using ALCOA++ principles.
Challenge overview
Background:
The client’s biologics development site had a growing inventory of complex lab systems, but internal teams were focused on research, not GxP equipment qualification, compliance, or data integrity.
Key challenges:
- Over 400 systems across diverse categories.
- Data integrity gaps and regulatory risk exposure.
- Limited internal resources for qualification, change control, and documentation.
- Need to scale while ensuring uninterrupted lab operations.
Our approach
Full-service embedded lifecycle program
- Embedded a cross-functional team (validation, lab ops, QA)
- Supported 420+ systems and >400 annual lifecycle service requests.
- Delivered over 60 GMP chamber qualifications and 100+ CSV projects.
Equipment qualification & lifecycle management
- Authored and executed CC, IQ, OQ, PQ.
- Managed system onboarding, decommissioning, relocations, and upgrades.
- Implemented asset tracking, eCMMS compliance, and chamber requalification.
Compliance oversight & change control
- Led Nonconformance and Quality Event resolution.
- Standardized change control processes and aligned with site quality systems.
- Remediated DI gaps in line with ALCOA++ principles.
System integration & support
- Supported LIMS and IT integration (e.g., balance-to-printer, pH meter setup)
- Troubleshot qualification issues and partnered with system owners for readiness.
Results & measurable impact
Pinnaql’s embedded lifecycle management model bridges the gap between scientific innovation and regulatory compliance. This case proves how external teams can integrate seamlessly to reduce risk, scale operations, and deliver long-term modernization across complex lab environments.
Key results
- 420+ systems managed across equipment families.
- 100+ computer system validation projects delivered.
- 60+ GMP chamber relocations and requalifications executed.
- Maintained zero 483s or warning letters.
- Strengthened cross-system data integrity and audit readiness.
- Accelerated system onboarding and improved change resolution timelines.
