Our IQ OQ PQ qualification and validation programs help your company assess, develop and implement regulatory compliance at the level you need, including the FDA’s Rule 21 CFR Part 11 and the EPA’s CROMERRR.
As your partner, we can determine the level of compliance and validation appropriate for your company. We then customize our services to compliment your in-house compliance and qualification/validation programs, allowing you to optimize resources. Our compliance consultants and engineers are experienced in Quality System:
- Assessment and Evaluation
- Development and Planning
- Master Plan Implementation and Review
And as your regulatory compliance partner, we will design a solid strategy for future regulatory compliance objectives as well as provide comprehensive support in meeting instrument validation/qualification and regulatory documentation needs, such as Temperature Mapping and Validation services.
Our qualification/validation offers:
- Complete maintenance history, system history, and inventory of components and documentation.
- Universal IQ, OQ, PQ template format.
- Verification of components’ installation including electrical, plumbing, and communication connections.
- Verification of components’ functionality, operation, and conformity to manufacturer’s specifications.
- Performance verification of laboratory equipment for routine R&D, QA/QC, EPA, FDA, and client-compliance operation.
- Pre-scheduled and annual instrument qualification/validation programs matched to your company’s needs and budget.
- Cost effective and fast turnaround for your laboratory equipment IQ, OQ, PQ verification.