Tandem’s offers Commissioning, Qualification and Validation Services to our clients. Our technically strong CQV personnel ensure all CQV activities meet both current regulatory requirements and client needs.
Tandem has extensive experience in the commissioning, qualification and validation of Biopharma, OSD, API, Labs, Warehouses, Med Device, Packaging Facilities, Utilities and Equipment
Tandem’s offering incorporates all elements of the CQV life cycle as outlined below.
Coordination: Management of the CQV phase to ensure full coordination between contractors, vendors, client and the CQV team
- Risk Based Verification: A Risk-based verification approach to the specification, design and verification of all systems and equipment that have the potential to affect product quality and patient safety
- Documentation: A robustly documented CQV campaign that stands up to audit by regulatory bodies
- Scheduling: Development and monitoring of a systems based CQV schedule to include all required test phases and interdependences
- Cost: Controlling and tracking CQV execution costs to an approved budget
- Safety: All systems are commissioned and qualified in a safe manner
- Risk Management: Identification of key risks with mitigations and owners to ensure their impact on successful CQV delivery is minimised