Media
Centre
Cobent
Master
List
PRESS INFORMATION ISSUED ON
BEHALF OF:
Cobent Group
The Guildhall, Chipping Norton, OX7 5NJ
Tel +44 (0)845 456 0630; Web
www.cobent.com
12th December 2007
Highlighting compliance for HR
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.
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 (
www.cobent.com ),
on jambrose@cobent.com
Ends
Notes for Editors
Cobent (
http://www.cobent.com )
Based in Oxfordshire, UK, Cobent 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, +44 (0) 845 456 0630;
hsears@cobent.com
Bob Little, Bob Little Press &
PR, +44 (0)1727 860405/ + 44 (0) 7850 508201