Originally Published MPMNMay2003

PRODUCT UPDATE

Applying 21 CFR Part 11 to Medical Plastics Processing

A paperless records-management system can give manufacturersa competitive advantage

byNorbertSparrow

When PCs began to settle into the workplace, pundits far and wide proclaimed the dawning of the age of the paperless office. Reality intruded, and those prognosticators subsequently went into hiding, joined recently by the new-economy gurus and the Dow 30,000 crowd. All of which is a roundabout way of saying that one might be inclined to take the latest bout of paperless cheerleading--focusing on the manufacturing sector this time--with a grain of salt. Skepticism is healthy, but there are ample reasons why processors of medical plastics and other materials should, in fact, listen up.

For one thing, establishing a paperless records-management system puts the manufacturer in harmony with the precepts of FDA's 21 CFR Part 11. According to Serge Jonnaert, executive vice president in charge of marketing for American MSI Corp., which has developed the CellTrack Pro production records-management system, that is but one of the compelling reasons why medical molders and extruders should kick the paper habit. He recently published a white paper on the topic, titled 21 CFR Part 11 for MedicalPlastics Processors.

Medical device manufacturers face increasing FDA oversight related to the documentation and tracking of recipes, processes, and production data, writes Jonnaert. Most companies have long maintained a paper record of basic equipment and process data. This practice is tedious and time-consuming and makes it challenging to adequately meet FDA reporting requirements, according to Jonnaert. It also hasa significant impact on overhead and efficiency.

"The cost increases exponentially as paper production records are archived and grow in size," writes Jonnaert. The inherent inefficiencies of paper-based systems are difficult to justify by today's standards, he adds. Increasing federal oversight and product liability issues should also give manufacturers pause. "A paperless batch records-management system provides instant access to detailed production data," writes Jonnaert, enabling a company to respond faster and more comprehensively to product quality and safety issues. Indeed, a paperless system can contribute to an improvement in product quality, he argues. Real-time visibility into all aspects of production can lead to improved employee monitoring and a reduction in operator errors, writes Jonnaert.

An effective production records- management system, according to Jonnaert, should capture batch, equipment, and operator data. 
"The batch information is a given. 

The equipment information should be captured as it relates to the production of a batch. And the operator information should focus on who did what, where, when, and even why, as it relates to equipment operation," stresses Jonnaert. Plastics processors should strive to correlate these requirements with FDA's definition of electronic records, he adds. Jonnaert describesthis process in great detail in his white paper, which can be downloaded at www.americanmsi.com/celltrackpro. 
 
A summary of the points he raises in the document follows.

Aspects of compliance

Electronic records. The system must be capable of recording raw data as well as so-called meta data (raw data translated into a table, graph, or other semantically friendly format). A good batch-recording system should allow the manufacturer to segregate active and completed batches, capture the various steps of downstream processing, and account for partial batches temporarily placed in a staging inventory.

Closed and open systems. The FDA rule defines a closed system as one in which "system access is controlled by persons who are responsible for the content of the electronic records that are on the system." Jonnaert concedes that bringing a manufacturing shop floor into a "closed system" can be a big challenge--industrial equipment was not designed to be part of a larger closed network. It's not impossible, however, and he lists centralized user-rights management, database alteration alerts, automatic and secure time-outs, and algorithm-based record validation as some of the key features of a closed manufacturing system.

Conversely, an open system is one in which access is not controlled by persons responsible for the content of the electronic records. This requires the implementation of additional controls to ensure a record's authenticity, integrity, and confidentiality.

Electronic signatures. The definition of the term in 21 CFR Part 11 makes it very clear as to what an electronic signature is and how it should be used, writes Jonnaert. To quote from the rule, "each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else" and it must "employ at least two distinct identification components, such as an identification code and password." Just as handwritten signatures can be forged, so can electronic signatures. FDA expects paperless systems to meet today's recognized industry-standard security measures. If a system is built on a platform with outdated security safeguards, it should be remedied immediately, suggests Jonnaert.

User rights management. Modern network operating systems already provide the means to manage user rights, which is described as a continuous process that maintains and verifies user identities and passwords. Jonnaert suggests considering adding features such as settings specific to each production cell, role templates that can be customized to grant specific access rights to an individual, and an active/inactive-user function. The rule stipulates that no user information can be deleted, so that an audit trail can always tie a record to an individual. By distinguishing between active and inactive users, writes Jonnaert, a change of status can be logged into the system.

Records management. To best meet the requirements detailed in 21 CFR Part 11, Jonnaert recommends storing the raw data as well as the meta data for each record, ensuring that records cannot be erased or overwritten, separating active from archived data, and choosing a system that can log almost all relevant activities. Flexibility is key when deciding on the means of storing the data. "The application architecture needs to be able to accommodate the various storage media available today including storage area networks, CD-ROMs, and DVD-ROMs, as well as technologies that may become prevalent in the future," writes Jonnaert.

Audit trails. Described as the raison d'être for production records management by Jonnaert, audit trails should include every data point that could be considered relevant to the quality of a part complete with a signature, date, and time stamp. "This includes but should not be limited to cell and equipment configuration changes, changes to recipe and process parameters, personnel activities and changes, batch records, and any reporting activities," he writes.

Reporting. A minimum system requirement should be the ability to output a report in an FDA-approved electronic file format. The ubiquitous Adobe PDF format is perfectly acceptable. Again, advanced security features need to be in place. Generating and printing reports should be limited to authorized users only, and the system should disable the Windows copy, paste, and screen-capture functions.

Data collection. There are few guidelines in the FDA rule relating to data collection on the shop floor. The primary challenge, according to Jonnaert, will be linking a 21 CFR Part 11-compliant application to the end points on the shop floor. "This requires the ability to communicate with both state-of-the-art machines that use complex data interface protocols as well as older equipment that is controlled and monitored using analog gauges and dials," writes Jonnaert. It's not impossible, but it requires a carefully thought-out strategy.

People and procedures. Retrofitting machinery, however, can be a cakewalk compared with changing staff habits. To enlist your employees' help in implementing compliant operating procedures, Jonnaert advocates taking a direct approach. Develop an information strategy early in the process with regular briefings on how the regulation applies to an operation and what the compliance initiative entails, he suggests. Don't neglect to provide plenty of advance warning to staff on what they should expect in terms of new policies, procedures, and management guidelines.

Validation. Once the system and accompanying policies and procedures are in place, FDA requires an audit by a third party to validate systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. Validation is a challenging and time-consuming process that should not be underestimated, stresses Jonnaert. The user is also required to show that a "specific electronic signature is the legally binding equivalent of the handwritten signature of the person using the electronic signature."

Achieving convergence

To his credit, Jonnaert doesn't sugarcoat the pill when he describes the challenges involved in implementing a paperless records-management system. "The path to compliance is riddled with many challenges that need to be addressed individually and, in the end, converge into a cohesive solution," he writes. "This implies selecting a solution that was designed first and foremost to meet compliance, and [partnering with] vendors that understand medical plastics processors and the framework of regulatory compliance in which they operate," he writes. Most important, don't lose sight of why you are doing this: to document your company's commitment to quality. Keeping thatin mind will help you to get through the inevitable rough patches.

Companies that embark on this mission, stresses Jonnaert, will benefit from an unquestionable image of quality in the marketplace. Implementing a paperless production records-management system that dovetails with CFR Part 11 requirements comes at a substantial cost, both financial and in terms of resource utilization, acknowledges Jonnaert. But the question is, can you afford not to do it?

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