Regulatory Compliance
Reports & Documentation
To enable the client’s internal quality standards to be upheld, PSK have realized the importance of producing high quality reports and validation documents, which will provide the client with evidence of the continued performance of the facility.
The documents provided give a clear and comprehensive guide to the current standard of the facility. Detailed methodology, Acceptance Criteria, Results and Summary Conclusions are provided, along with all relevant supporting documentation including facility drawings, calibration certificates, equipment and location reference drawings and raw data collected during the validation exercise.
PSK can design and build your facilities to comply with all regulatory standards
Protocols
For any new or modified cleanroom facility, PSK understand that it is essential to have a structured system in place to ensure your facility is designed, built and performs to the required standard.
PSK can assist in the production of User Requirement Specifications and the following essential documents:
- Design Qualification (DQ) : Used to provide documented evidence that the proposed design of the facility meets with the user requirements and cGMP.
- Installation Qualification (IQ): Gives the documented evidence that the facility has been installed in accordance with the agreed design.
- Operational Qualification (OQ): Provides evidence that the installation operates as specified and within the agreed specification parameters.
- Performance Qualification (PQ): Gives a documented programme that the facility will perform consistently within the pre-determined parameters, during periods of operational use.
