New Systems—The Practical Implications

Whatever one s opinion of the rule, this is a much easier situation to manage than that of bringing legacy systems into compliance. However, it is not without its challenges. The interpretation of the rule for each organization needs to be worked out, and, as in other GxP areas, each organization will develop its own, sometimes unique interpretation. 

This section suggests some pragmatic interpretations that may be applied to the clauses in the rule, although the detail will inevitably be modified by current policies, procedures and practices in your organization. 

For the FDA, the key issues surrounding electronic records are those of authenticity and integrity. Consequently, the rule sets out a series of conditions that are designed to protect these principles. Many of them are not new to us, at least in part, since they are practices already adopted by many organizations to protect their data from corruption or loss for sound commercial reasons— what might be called Good IT Practices . 

It is no surprise to find that systems generating electronic records should be validated, staff should be trained, access must be controlled and many 

This brings up issues of archiving and retrieval. As long as the system is running, this is not problematical. However, when the system is retired, provision needs to be made to continue to retrieve the records for the requisite period. System retirement is not a trivial task, and procedures need to be developed for this activity if they do not already exist. 

---