To enable the client’s internal quality standards to be upheld, Enbloc have realised 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 Enbloc provide 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.
Enbloc can design and build your facilities to comply with such regulatory standards as:
BS EN ISO 14644 – Range of cleanroom standards that is produced by the International Organization for Standardisation (ISO).
Fed 209E. This has now been superseded by the ISO 14644 family of documents.
Other guidelines include:
For any new or modified cleanroom facility, Enbloc 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.
Enbloc can assist in the production of User Requirement Specifications and the following essential documents:
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