• Evaluate
                • Specify

                            • Integrate     

                                           • Verify

             

Validation

Validation activities:

· Validation Master Plan

· Risk Analysis (FMEA)

· Functional Specifications

· Software Design Specification

· Traceability matrix

· IQ/OQ/PQ test protocols

· 21CFR Part 11 compliance

· GAMP V-Model approach

 

Member of the ISPE

Metro’s Automation Group believes that one of the key deliverables for any  automation project is to “provide documentary evidence that the system operates as specified.”

We use a risk-based approach to validation that provides a rational framework for developing an appropriate scope for validation activities, focusing on processes that have the greatest potential risk to product quality.

This risk assessment approach uses a Failure Modes and Effects Analysis (FMEA) to evaluate the impact of potential system or module failures and the likelihood of their occurrence.

METRO MACHINE

8001 WALLACE ROAD

EDEN PRAIRIE, MN  55344-2296

Tel: 952-259-3646 

Fax  952-937-2374

Email:  Automation Group

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