Strategies for Bringing Existing Systems into Compliance

STRATEGIES FOR BRINGING EXISTING SYSTEMS INTO COMPLIANCE 

Whilst compliance with the rule is not without its challenges for new systems, they are small by comparison with those involved in bringing existing (sometimes known as legacy) systems into compliance. 

The regulation does not apply to records created before 20 August 1997. However, those same systems that were perfectly satisfactory on 19 August 1997 were in most cases producing noncompliant records on 20 August when the rule came into force. The FDA wants to see plans to ensure that all records are compliant. The complexities of achieving this have been the source of 

The situation is closely paralleled by that in the early 1990s when regulators in both the United States and Europe started enforcing the validation of computer systems the industry had to work its way back into compliance. The solution is similar too. 

A ring fence has to be drawn around the noncompliant systems, and a methodology worked out for bringing them back into compliance. There are five strategies available to us  

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