Cobent has published a Whitepaper which examines the increasing regulatory requirements placed upon HR/Training directors and suggests a best practice method of providing tamper-proof training records
United Kingdom of Great Britain & N. Ireland (Press Release) December 11, 2007 --
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: “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."
Copies of the Whitepaper are available, free on request, from Jordan Ambrose at Cobent (www.cobent.com), on jambrose@cobent.com
Ends
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: “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."
Copies of the Whitepaper are available, free on request, from Jordan Ambrose at Cobent (www.cobent.com), on jambrose@cobent.com
Ends
Email
Print
SPAM
LEAVE A COMMENT
