By Doug Bartholomew, Contributing Editor As more pharmaceutical manufacturers strive to improve the quality of their operations and product, corrective and preventive action (CAPA) software is becoming a more important tool. The software is designed to help users respond to adverse events, which can range from a customer complaint about a given product, to raw ingredient non-conformance on the production floor or receiving dock, to an FDA warning, explains Tom Trahan, principal with Trahan Associates (Rosemont, Ill.). This relatively new breed of application software captures data and allows companies to evaluate the information and develop corrective action plans. The best systems, whether database- or process-driven, offer rigorous traceability and documentation as well as visibility throughout the organization. In the relatively short time that CAPA systems have been around, they've forced individual facilities and whole companies to automate systems and processes that had previously been handled manually. Now available in comprehensive product suites encompassing change control, audit management and supplier compliance, CAPA systems can now be used to track documents, foster fail-safe workflow processes, and enable quicker, more certain resolution of errors or unusual production issues. Instead of standalone CAPA systems, more companies now require linkages with change-control, SOPs and site audit management software, Trahan says. The software is also proving important in analyzing trends, allowing companies to take preventive actions. No longer limited to the QA/QC silo, CAPA systems are also commingling with broader corporate information systems. The next stage will be linking them to enterprise resource planning (ERP) systems. "At this point, most manufacturers aren't there yet," says John McLaughlin, principal consultant at Taratec Development Corp. (Chicago). "But in the future, they're likely to demand that their CAPA systems share data with ERP." "They'll want to set up automatic monitors that trigger certain processes, automatically, when some threshold value is
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Topics of Interest
By Doug Bartholomew, Contributing Editor Investigating the cause of a quality failure or other production problem is something that all pharmaceutical companies must do some more frequently...
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