S
SpeedRacer24
Hi Folks,
This is my first posting here. As a Medical Device manufacturer we currently have several internally created Access databases that we use for our Quality System. One manages our CAPA system, another Internal Audits and the other for Nonconformance reports. It is a hybrid system in the sense that while the data resides in the databases we print out the records, sign them, have them on file and consider them to be the primary record. As such the databases I have created do not use a true electronic signature system. I have security enabled on both the backends (data on network) and frontend databases (on users PC's). People need to enter their user name and password to logon and I have a VBA Audit Trail to record any and all changes to the records by user including time and date.
I've read and re-read the "General Principles of Software Validation" from the FDA and still cannot determine a clear method of exactly how to validate these databases. I know I need to come up with a Software Requirements Specification for each database and have downloaded several templates from the Internet for use. The next steps I believe would be to come up with the validation protocol, acceptance criteria, test cases with results and finally a validation summary. I was wondering what others here might have done to validate their databases (especially those created with off the shelf software like Access) and if anyone could point to somewhere on the Internet I could go to to look at an actual example validation from start to finish. Any and all help would be very welcome. Thanks in advance.
Roger Tregelles
Quality Assurance Engineer
This is my first posting here. As a Medical Device manufacturer we currently have several internally created Access databases that we use for our Quality System. One manages our CAPA system, another Internal Audits and the other for Nonconformance reports. It is a hybrid system in the sense that while the data resides in the databases we print out the records, sign them, have them on file and consider them to be the primary record. As such the databases I have created do not use a true electronic signature system. I have security enabled on both the backends (data on network) and frontend databases (on users PC's). People need to enter their user name and password to logon and I have a VBA Audit Trail to record any and all changes to the records by user including time and date.
I've read and re-read the "General Principles of Software Validation" from the FDA and still cannot determine a clear method of exactly how to validate these databases. I know I need to come up with a Software Requirements Specification for each database and have downloaded several templates from the Internet for use. The next steps I believe would be to come up with the validation protocol, acceptance criteria, test cases with results and finally a validation summary. I was wondering what others here might have done to validate their databases (especially those created with off the shelf software like Access) and if anyone could point to somewhere on the Internet I could go to to look at an actual example validation from start to finish. Any and all help would be very welcome. Thanks in advance.
Roger Tregelles
Quality Assurance Engineer