This procedure package includes two documents:
1. Monitoring of Controlled Environments Procedure
Purpose – The purpose of this (3)-page procedure is to define your company’s requirements for monitoring of controlled environments.
Scope – This procedure applies to the regular environmental monitoring of cleanrooms. Additional testing may be required under special circumstances. Monitoring frequency, locations and number of samples shall be based upon reference standards identified in this procedure (i.e., ISO 14644 series of Standards).
This procedure is the primary document meeting the applicable regulatory requirements for environmental monitoring as defined in your company’s Quality System Manual…
2. Environmental Monitoring Record Form
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