John
John Cuspilich, Sr. Consultant
Posts: 229
Loc: NJ, USA
Registered on 10-23-02
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 04-08-05 03:31 AM - Post#1653
In response to Anonymous
You must do 2 things;
1. Properly and formally document all anomalies found during the execution of the OQ phase of the validation, and include these issues in the OQ summary statement (report) prior to releasing the program for use.
2. You must conduct proper risk assessment of all of the known anomalies: (in accordance with your company’s risk assessment policies, procedures (SOPs) and practices). Does the anomalies;
a. Impact the validity, efficacy, stability or integrity of the data?
b. Compromise the integrity of system?
c. Violate requirements set forth in Title 21 CFR Part 11, i.e. audit trails, security, etc…?
d. Violate security, validation, integrety and stability aspects of the individual systems, servers, clients and the network?
e. Require users to document, record or manage associated data in other systems?
f. Require users to circumvent the user requirements, functional requirements or manufacturers (developer) operations and user instructions? Do the anomalies require additional documented procedures to ensure that the anomalies are properly identified and work-around processes are formally trained upon in accordance with formal training procedures?
g. Require short term fixes properly documented and trained upon?
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