Axentis LLC Enhances Application To Comply With 21CFR Part 11
The application, which is the first and only solution to comprehensively address the seven steps of an effective compliance program, as determined by the federal government and the U.S. Sentencing Commission, has enhanced its already robust capabilities with the addition of a custom-configurable electronic signature feature and a comprehensive, all-encompassing audit trail. Axentis Enterprise can now be used to electronically log and track audit observations, changes and modifications, deviations and instances of non-compliance, investigations, and any resulting corrective and preventive actions. "These enhancements improve efficiency and reduce costs by automating manual tasks and streamlining processes that are currently duplicated in the traditional paper routing process," said Gary M. Fingerhut, Axentis Senior Vice President and Chief Technology Officer.
The FDA issued a final rulemaking for Part 11, electronic records and electronic signatures, in the Federal Register of March 20, 1997 (62 FR 13430). 21 CFR Part 11 went into [[Page 8670]] effect on August 20, 1997and is intended to create criteria for electronic recordkeeping technologies while preserving the agency's ability to protect and promote the public health; e.g., by facilitating timely review and approval of safe and effective new medical products, conducting efficient audits of required records, and, when necessary, pursuing regulatory actions.
21 CFR Part 11 describes the technical and procedural requirements that must be met if an organization chooses to maintain records electronically and use electronic signatures. It applies to those records and signatures required by FDA predicate rules, as well as signatures that are not required, but appear in required records.
Axentis' application, Axentis Enterprise was recently audited by an independent third-party and declared a qualified 21 CFR Part 11 application. This is a significant milestone for Axentis as it continues to develop best practices in governance and compliance for companies in highly regulated industries, particularly pharmaceutical companies who make up a large portion of Axentis' current clients and where managing FDA regulations are a constant challenge.
Since its inception, Axentis has successfully helped organizations manage their governance and compliance initiatives using its closed-loop, rapidly deployable solution. Axentis Enterprise is already an ideal, cost-effective, comprehensive governance and compliance solution. "With this enhancement Axentis is now able to more efficiently address the seven steps of effective compliance, particularly high-level oversight and auditing, monitoring and reporting," said Fingerhut, "and, at the same time, meet a number of rigorous quality and control requirements, including ISO and QS standards."
Compliance is just one of the benefits gained by implementing 21 CFR Part 11 requirements. These powerful enhancements yield many other benefits as well. Authorized users can now view the activity history and not only quickly determine the current state of a problem, but also exactly who is involved and what has been accomplished. "This is critical for FDA regulated and non-regulated organizations," said Fingerhut. Organizations of all kinds will also benefit from:
· Improved efficiency by maintaining version control and quality standards
· Faster time to market by avoiding the costly time delays associated with lengthy approval cycles
· Risk avoidance helping organizations prepare for third-party audits and FDA inspections
· Improved workflow and automation of processes by migrating from paper to an electronic-based environment
· Cost effective solution that comprehensively addresses quality assurance, quality control, regulatory issues and manufacturing challenges
"This is a very exciting time for us and for the FDA regulated industry as well," said Fingerhut. "As it stood, a product like ours wasn't available to a whole group of people because companies that are FDA mandated have to use Part 11 compliant solutions, even if the implementation has nothing to do with the manufacturing requirements. As we expand our functionality to address Part 11, we're expanding our ability to provide our solution to a whole new group of clients."