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What Small Businesses Should Know About 21 CFR Part 11
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By Curt Finch

In 1997, the United States Food and Drug Administration (FDA) overhauled its GMP, or Good Manufacturing Processes. Out of the ashes came 21 CFR Part 11, a regulation that places certain demands on drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries regarding their use of technology—specifically, defining the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

Accuracy and accountability are extremely important with the use of such records, and this strategic initiative is aimed as ensuring that both are upheld in both manufacturing and product quality. The main issues that Part 11 addresses are audibility and the validation of electronic signatures, and it governs much of how pharmaceutical companies document their processes and procedures from research to marketing. Any small business that intends to sell into the pharmaceutical market—through conducting research studies, for example—will fall under the regulatory standard as well.

Luckily, there are employee time tracking software solutions that can help small businesses be Part 11 compliant. The first step is to know what you are looking for. The right solution must exhibit several qualities:

• First, it must meet the most critical requirements of the standard, which are audit trail generation and storage functionality. Historical data is a key functionality of an application associated with audit trails, and your software must capture and preserve all the data associated with adding, changing and deleting time-related information in a real-time database that can be audited.

• Second, as with all technical controls, there must be a management and operational component that ensures compliance with the regulatory standards. Established policies and procedures that provide guidance and control implementation details associated with the authenticity, integrity, and often, the confidentiality of electronic records (i.e. timesheet audit trails) are necessary.

Software alone will not solve your 21 CFR part 11 compliance problem, just as it doesn’t solve Sarbanes-Oxley or DCAA compliance issues. You must also have a third-party validation process for the system, documentation, and configuration to ensure that the processes, policies, procedures and technical controls are in place and are effective based on the regulatory requirements of the organization.

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Curt Finch is the CEO of Journyx. Bruce A. McGraw is the CEO of Cognitive Technologies.
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