21 CFR Part 11 Takes Center Stage at Interphex

Erik Swain

Interphex always provides a good indication of current hot-button issues in the pharmaceutical industry. Judging from the presentations and displays at this year's show, held April 15–17 in New York City, there is no hotter issue than compliance with 21 CFR Part 11, which covers electronic records and signatures.

Lengthy workshops were devoted to it. Software manufacturers peddled new systems purporting to make firms comply with Part 11, or programs designed to bring older systems into compliance. Even packaging equipment vendors touted their machines with "Part 11 compliant" posters.

For many pharmaceutical and medical device firms, the regulation does affect packaging operations, but only by choice. Part 11 covers any aspect of operations for which the company wants to employ electronic records and signatures. For some, that can cover every function they perform; for others, only certain operations; and for others, none at all.

But, software vendors and others said, FDA has begun to regulate Part 11 very tightly in recent years, so implementation of electronic records and signatures must be done with great care. While the regulation emerged in 1997, FDA was more concerned with Y2K compliance in the first years of Part 11's existence. Now that Y2K concerns are over, FDA has turned its attention to Part 11 enforcement.

Keith Chambers, senior product evangelist for Intellution Inc. (Foxborough, MA), told attendees at one workshop that, despite all the regulatory pressure, firms should look at implementing Part 11 on the plant floor as an opportunity.

"The manufacturing floor presents a major opportunity for productivity gains and cost savings by using electronic records to meet the requirements of CGMPs," he said. Among its potential benefits, he noted, is the simplification of the reconciliation of materials, including packaging materials.

The steps to efficiency, he said, include recording temperatures, pressures, and other parameters automatically; and enforcing the correct sequence of operator workflow, capturing deviations, and maintaining an audit trail to show that everything was performed as expected. These can apply to all steps of the manufacturing operation, including packaging.

One crucial aspect all compliant systems should have, he said, is "point verification" for electronic signatures. That verifies who is requesting an action by asking for a password at the time of the action, to prevent an unauthorized person from doing an unauthorized task on someone else's workstation.

Another essential feature, he said, is to store each electronic record with its audit trail, to show when and why each change was made. Audit trails should show a full user name, time stamp, reason for change, and specific "from-to" change information. In addition, he said, passwords should be changed routinely to prevent sabotage, but each person should not have a whole lot of passwords, lest they forget any of them.

It is also important, especially when bringing old systems into compliance, to have a plan to show FDA, said Alexander E. Abramov, MBA, an information manager at Bristol-Myers Squibb Co. (New York City) and another presenter at the workshop. "You must be clear about who is responsible for what," he said, suggesting that most duties should be split between the quality assurance and information management departments.

The range of software applications that can assist with Part 11 compliance is staggering. Some providers, such as Werum America Inc. (Towaco, NJ), offer "total information integration" systems. Werum's PAS-X, for example, incorporates production planning and scheduling, material flow control, warehouse management, dispensing operations, packaging-line control, and calculation of key performance indicators, among other functions. Werum has also collaborated with Uhlmann Packaging Systems Inc. (Towaco, NJ) on its Netmaker 5.1 production software package, which automatically downloads all product and production data required for process optimization.

Another software suite, the Regulus 3.0 from Decision Management International Inc. (DMI; Bradenton, FL), provides a configurable and integratable set of Web-based applications that requires no software customization, and purports to enhance Part 11 compliance through electronic document management, equipment and calibration records tracking, order management, and other features.

"Over the next two years, FDA will be adding a lot more inspectors, and this is one of the issues they will be taking a hard look at," says Charles Norz, process marketing specialist for Rockwell Automation (Milwaukee), whose divisions also offer software packages to enhance Part 11 compliance. "The pharmaceutical companies are demanding that the issue be solved, and we are working to meet their needs."

The rule, and documents related to it, can be viewed at www.fda.gov/ora/compliance_ref/part11/.

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