We have recently completed the validation of a computer system which has given rise to numerous minor snags, non conformances which we discovered during OQ. However from a GXP viewpoint these snags have no effect on the overall function of the system and are not considered critical to our process. Our vendor correcting these snags and they will be delivered with an upgrade of the MES system in the future. Is it acceptable to proceed and qualify the system with these issues outstanding or should we wait for the upgrade and requalify? My intention is to qualify on interim basis but i would be grateful for any views
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?
Sincerely, John F. Cuspilich, Sr. Consultant RA/QA
FDA.COM
The Auditing Group, Inc.
GMP Publications, Inc. jcuspilich@auditing.com jcuspilich@fda.com
856-596-2333 - 866-GXPNews
It all depends on the snags. If they are not life threatening as I am assuming from your description, you can continue with validation by doing two things:
1. Document all snags in the issues log including its disposition and or resolution. Attach the issues log with final compliance report.
2. Create the Modification requests and provide their dispositions along with any solution if there is any. Attach all modification request numbers with the final compliance report.
Worthwhile looking at the details in the GAMP4 guide from ISPE. A great resource for all computer system validation. Additionally GAMP staff are now training FDA inspectors in CSV and ERES details.
04-01-05 03:40 AM - 