Increasingly, regulated industries – notably those in the life sciences sector - require organisations to keep comprehensive data and reports showing compliance to regulatory needs. While these must be robust and come from an unimpeachable source, manual record keeping can be easily flawed and electronic record keeping is not foolproof either – although one system now meets the requirements of the most stringent regulations.
This is the main conclusion of ‘Best Practice approach to learning compliance management in regulated industries’ – a new Whitepaper from regulatory compliance systems specialists Cobent Group.
Cobent, a leading provider of solutions for e-learning, training and compliance-led process management across the entire range of international blue-chip companies, fast-growth start-ups, and public sector organisations, claims that its Learning and Compliance System (LCS) is currently a lead product in helping to meet these guidelines.
“Most LMSs employ a process which is open to a number of possible unauthorised interventions,” explained Jordan Ambrose, Cobent’s Sales Director. “Even with electronic automation, the integrity and validity of the training document could be called into question under a compliance audit.”
Cobent, a UK-based company believes that the most stringent compliance regulations in the world are those of the United States Food and Drug Administration (FDA) – especially its 21 CFR Part 11, which aims to achieve more efficient work practices and demonstrate the validity of information where computers were used to replace previously paper based operations.
According to Howard Sears, Cobent’s CEO: “Part 11 was designed to produce a minimum set of standards for electronic records and signatures, making them equivalent to conventional paper records. Importantly, these regulations apply not just to businesses in the US but also to any company internationally selling into the US market.
“Regulation 21 CFR Part 11 is now a benchmark standard for any system which keeps electronic documents or uses electronic signatures.”
Ambrose added: “So, it is no longer enough just to provide an electronic equivalent of the manual process unless the system on which this is achieved passes the requirements of 21 CFR Part 11.
“Since the Cobent LCS system is compliant with the technical controls required for the storage of electronic records under FDA 21 CFR Part 11, the client can be confident that all data changes are recorded and security is assured through a comprehensive permission hierarchy and the administration of e-signatures.
“The area where compliance and learning meet is now one where there is significant need for adherence to regulations. Failing to provide the necessary integrity in the process of training and collecting the required data is a risk that no organisation should take,” said Ambrose.
Copies of the Whitepaper are available, free on request, from Jordan Ambrose at Cobent, from jambrose[.]cobent.com
Based in Oxfordshire, UK, Cobent (cobent.com) provides solutions for e-learning, training and compliance-led process management across the entire range of international blue-chip companies, fast-growth start-ups, and public sector organisations. Cobent enables its customers to achieve regulatory compliance and learning management across the entire organisation, empowering them to manage compliance governance quickly and cost-effectively. Creating reports that are compliance-ready at the outset, Cobent delivers the market’s most reliable, flexible, and compliant solution for distributing organisation-wide learning management via the web. Cobent works with organisations in the life sciences, government, financial services, education, retail and call centre sectors.
Further information from:
Howard Sears, Cobent Group,
T:+44 (0) 845 456 0630