Compliance Documentation

The correct documentation is critical in ensuring and proving any changes are in full compliance with the clients quality system therefore regulatory standards and guidelines.

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compliance documentation

life science

risk assessment

The level of documentation required will be determined area by and appropriate for each classification and product risk

Product Risk Assessment
Change Control Documents
Approved Design drawings /schematics
Functional Requirement Specification (FRS)
IQ / OQ
Client SOP changes
Documentation review and Approval carried out by the clients Engineering / Production / Quality Assurance /EHS

Compliance Documentation

The level of documentation required will be determ...