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7.5.2.1 General requirements :
General :
Version:
1.0
Project :
Author:
Wolfgang Kern
Created:
07.03.2014
Modified:
13.09.2017 11:07:26
Diagram Elements :
Do Performance Qualification (PQ)
Performance qualification (PQ) report
Do Operational Qualification (OQ)
Do prototype transfer (Process development)
Production staff instructions
Specify instructions for production staff
Production area
Specify production environment
Process qualification review report
Review and mark production process as approved
Do pilot serie transfer (Process validation)
7.5.2 Validation of processes for production and service provision : 7.5.2 Validation of processes for production and service provision
7.5.2.1 Procedures for validation of computer software
7.5.2.1 e) Revalidation
7.5.2.1 d) Requirements for records
7.5.2.1 c) Specific methods and procedures
7.5.2.1 b) Approval of equipment and qualification of personnell
7.5.2.1 a) Criteria for review and approval of the processes
7.5.2.1 Validation shall demonstrate the ability of these processes to achieve planned results
7.5.2.1 Validate any processes for procuction and service provision where the resulting output cannot be verified
