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Although in some areas the regulation is very specific, for example, it not only requires an electronic audit trail to demonstrate data integrity, it also specifies some attributes, but in other areas it leaves a lot of room for interpretations, for example, about the scope of Part 11.

The biggest problem is finding a compromise between doing too much and satisfying minimum requirements.

paper records: tangibly lower space requirements and easier retrieval are just two of those advantages.

Although the rule is well-documented and the FDA gave an interpretation to 130 industry comments in their preamble, corporate IT professionals and analysts in laboratories are often unsure when it comes to implementation.

In many situations using computers cannot be avoided, for example in analytical laboratories for automated data acquisition and evaluation.

In this case the laboratories “must” comply with Part 11. There may come a time when the FDA will no longer accept paper records and; Electronic records have some significant advantages vs.

Learn from FDA 483's and from detailed EIR inspection reports what FDA inspectors look for, what questions they ask and if company's response is satisfactory.Learn from the FDA about Part 11: past, current and future.Learn from FDA warning letters what FDA inspectors look for and what mistakes others make, so you can avoid them.Industry representatives met many times with the FDA's task force under Paul J.Motise to determine how to accommodate paperless record systems under the current Good Manufacturing Practice (c GMP) regulations.




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