Commissioning, Qualification & Validation
Robust, well documented verification of system installation and operation.
Commissioning, qualifying, and validating all systems, equipment, and processes to operational readiness.
Tandem’s CQV services are tailored to meet the specific needs of our clients. Our technically strong CQV personnel utilise proven procedures to meet both current regulatory requirements and your needs.
Tandem’s extensive experience spans the CQV of Biopharma, OSD, API, Labs, Warehouses, Med Device, Packaging Facilities, Utilities and Equipment. Our expertise identifies and reduces CQV related risks to minimise any unexpected setbacks.
Tandem’s offering incorporates all elements of the CQV life cycle as outlined below:
Safety
All systems are commissioned and qualified in a safe manner.
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.
For robust, compliant, well planned and well executed Commissioinng, Qualification and Validation services, please contact Tandem Project Management today.
