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
- 6 months shaved off the original 15-month project timeline.
- Millions in revenue protected through on-time product launch.
- Delivered full OSD line from design through PQ in 9 months.
- Operated a 24/7 validation schedule to prevent delays.
- Coordinated with OEMs to accelerate equipment delivery.
- Achieved GMP readiness with zero compliance issues.
Challenge overview
Background:
The client faced pressure to commercialize a new oral solid dosage (OSD) product within a condensed timeline—reducing a 15-month project to just 9 months.
Key challenges:
- Accelerated project lifecycle.
- Vendor coordination and equipment procurement.
- Full GMP compliance under time constraints.
Our approach
Program acceleration & project management
- Built a critical path for design through PQ in 9 months.
- Led capital approval process.
- Managed 24/7 validation schedule.
Process design & vendor integration
- Delivered full clean room and utility upgrades.
- Fast-tracked equipment sourcing using OEM relationships.
Commissioning & qualification (C&Q)
- Executed IQ/OQ/PQ aligned with site and GMP standards.
- Synchronized FAT/SAT and delivery schedules.
Results & measurable impact
This case shows how integrated CQV, project management, and vendor orchestration can compress timelines without compromising compliance—an essential capability in today’s competitive market.
Key results
- On-time commercial launch.
- Delivered 6 months ahead of schedule.
- 24/7 qualification schedule mitigated potential delays.
- Preserved millions in revenue.
- Zero compliance issues at go-live.
