CAPA Software Comes Out Of Isolation

PharmaManufacturing.com

Once Locked in the QC Toolbox, Corrective and Preventive Action Systems Are Now Improving Processes Company-wide

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 reached," adds Trahan.

Quality Improvement Still Driving Force

Quality improvement is still the key driver for installing a CAPA system. At Bristol Myers Squibb (BMS), for example, the company's Flow Path system ensures that employees follow up on errors or quality issues more promptly than they'd been able to do with paper-based processes. The system maintains "follow-up" metrics that employees can meet or exceed, explains Susan Kenney, manager of lot release documentation, quality assurance systems, and training, based in Garden City, N.Y.

"With our new system, we created an automatic metric to work toward for both minor and major errors," she says. The CAPA system requires employees to record errors by category, product, and lot number, allowing for automatic trending. "There is no way to know that a trend is occurring with a manual system," she says. Trending also gets management involved, Kenney says. "They can watch the flow of each product and see the trends online."

BMS is also using CAPA software to track how each product was developed and produced, and to manage all supporting paperwork. "Our site director felt that the documentation associated with the product was just as important as the product quality or getting the product out the door."

Developed with the software vendor, Invistics (Atlanta), the company's CAPA software works hand in hand with its inventory tracking system. "Invistics developed a front-end piece for us that shows a web page for each shop order, so that anyone using the system could see where we were," Kenney points out.

"We can instantly see whether we are on time, behind, or late with the order." Before installing this system, she says, employees used paperwork to keep up with each shop order, a cumbersome process at best. BMS also uses the system to track the status of process changes. "After installing the CAPA system, BMS had 32 consecutive months of on-time product delivery," Kenney says.

She believes that an effective CAPA system is a necessity for a smooth operation. "I'm amazed at the number of pharmaceutical companies that don't want to take the time to automate their systems," she says. "My sense is that the industry is just not moving fast enough."

User Base Extends Beyond QA

Watson Pharmaceuticals, a $1.5-billion maker of branded and generic drugs, is also a believer. "CAPA is essential should anything ever occur out of the ordinary," says Phil Lofty, manager of computer systems for corporate quality assurance at the Corona, Calif.-based firm. "You need to keep track of the information and you want to be very timely," he says. A built-in timer alerts users to deadlines, so that action items can't sit in anyone's virtual inbox for too long. "This CAPA system reduces our cycle time for making the corrections," he says.

Watson had been using a CAPA system from Sparta Systems (Holmdel, N.J.) at one plant and decided to expand its use throughout the company's operations. "This electronic-based system enabled us to work through our various site-based differences, so that we were able to roll it across all sites," Lofty says. "With electronic signatures, we don't have to track down paper related to quality issues anymore. We've gained a considerable amount of time not having to track paper."

The web-based system has proved a boon to management, too, he says, since they can monitor the progress of quality-oriented fixes. "It gives management a tool to see how long it takes to make a correction at a particular site," Lofty says. "We use the CAPA system broadly, for any corrective action."