Cleanroom Design and Validation Procedure
The Cleanroom Design and Validation Procedure governs the design, build and validation of cleanrooms to ensure compliance with User Requirement Specification (URS), DQ, IQ, OQ, PQ, and certification activities, per applicable standards and regulations, and to ensure the facility is fit for its intended purpose.
- ISO 14644:2015 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
Cleanroom Design and Validation ProcedureThe Cleanroom Design and Validation Procedure governs the design, build and validation of cleanrooms in accordance with ISO 14644-1:2015, ISO 14644-2:2015, and ISO 14644-4:2001 and other applicable standards and regulations.
Cleanroom Design and Validation Procedure - OverviewThe cleanroom design and validation procedure governs cleanroom installations from concept through certification. The procedure provides instruction on the development of a User Requirement Specification (URS) that is the foundation to any cleanroom installation project.
The cleanroom design and validation procedure includes instruction on the entire qualification process including required content for:
Cleanroom Design and Validation Procedure - ComplianceThe cleanroom design and validation procedure complies with ISO 14644-1:2015, ISO 14644-2:2015, and ISO 14644-4:2001, ISO 13485:2016 and FDA QSR.
For more information about our Cleanroom Design and Validation Procedure contact us at [email protected] RELATED LINKS |
Cleanroom Validation Procedure
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- ISO 14644-1:2015 Compliant
- ISO 14644-2:2015 Compliant
- ISO 14644-4:2001 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Includes Related Forms
- Digital Content - Instant Download
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