TABLE OF CONTENTS After operational release comes the most difficult part of computerised system validation maintaining the validation status of the system throughout its whole operational life. The key challenge is change control.
211.68(b)12:
Appropriate controls shall be exercised over computer or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Clause 1127:
Alterations to a system or to a computer program should only be made in accordance with a defined procedure which should include provision for validating, checking, approving and implementing the change. Such an alteration should only be implemented with the agreement of the person responsible for the part of the system concerned, and the alteration should be recorded. Every significant modification should be validated.
Table 28 lists some of the items that an inspector could look at during a visit to your laboratory; it is taken from the PIC/S Guidance on Computerised Systems in GXP Environments.31
| 18 Change control and error report system (PIC/S guidance 200331) |
| 18.1 The formal change control procedure should outline the necessary information and records for the following areas:
|
