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Janet Gough on Transitioning to an E-System
Electronic systems require four essentials: validation, security, audit trails, and accountability. None of these is clear-cut, and companies still struggle to make sense of the very vague Part 11 regulation - which itself was slated for revision by 2006 to focus on risk, but industry has yet to see it.
The current, original final rule provides little help in the actual "how to" for bringing a system on board, and more than one company has found itself mired in the transition process after having selected a suitable vendor, agreed to contractual terms, and purchased a configurable off-the-shelf (COTS) software program.
Compliance of electronic documents can be easily and inexpensively achieved through the proper use of Microsoft Word to author documents, combined with the use of templates with electronic submission compliance features built into the template design.
John Avellanet of Cerulean Associates says a collision between technology and regulation will soon be facing FDA-regulated industry. The need to cut corporate expenditures is leading companies to outsource data centers to vendors using computer virtualization. What effect will this have on Part 11 compliance?
Most supervisors would agree that their staff wants to do a good job and that their employees do their best to meet the demands of the highly regulated blood bank industry. But occasionally management has to deal with employee performance that falls short of expectations. This issue becomes increasingly important if the employee has committed an error more than once, in spite of attempts to correct the problem.
Did you know there's more than one way to kill a CAPA? A new approach to QMS and CAPA management isn't necessarily a revolutionized approach from the one your company already employs. Ken Peterson, CAPA expert and founder of Pathwise, Inc., states that "Making a few well-timed changes to build more intelligence into your process by having key questions prompt you from data point to data point can make it easier for those doing the work, as well as for those who need to see the logic."
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