In response to sdnare
Dear sdnare,
Part 11 is to be part of computer validation. So your question is a bit difficult. Part 11 focusses on records and signatures, there retention and integrity.
All depends on the type of system, how it generates and stores data,how you will use the system, and what you want to do with the raw data generated by the system.
This is what is written in the pretext of part 11. You need to decide how you want to meet the predicate rules with your IT system.
What you would like to start with is some assessments of your system. A part from the functionale analysis, try to have a picture of the dataflow as well. Point out what data is relevant for you, at which given states signatures are needed. (General rule of thumb is that all procedural signatures you used to put on papers, need to be done in the IT system as well. But sometimes some signatures can be left out because of the particularities of the IT system)
Once you know functionalities, critical data (=ER: electronic Records), signatures (= ES: Electronic signatures), you need to define how you will catch and retain this data and signature (event log, audit trail, database).
As a last you need to know how you want to have your final reports/trends that they can reproduce a correct comprenhensive reports.
Now you have all parts of the system you want to qualify and validate.
An top of this all you have other topics that are more IT management related, but some do touch part 11 issues:
- BCP (business continuity) -> record integrity
- Backup-restore -> record retention (retrieving and reporting of histrorical data)
- Datamigration -> critical data
- and especially change control!!!
All depends of what kind of system, cause a weighing system is in almost nothing comparable to an ERP system.
I suggest you start reading the GMP's on part 11 and try to establish how your company wants to interpret them. Your company may already have procedures telling you what the company considers as source GMP data (paper or electronic..)
Cheers
Edited by JohanJ on 03-31-09 07:32 PM. Reason for edit: No reason given.
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