Gael Ltd looks at the proposed changes to EU GMP Annex 11

As the NHS celebrates its 60th birthday, healthcare organisations need to keep abreast of changing statutory health and safety compliance requirements both in the NHS and internationally.

In April 2008, in response to the increased use of computerised systems in the healthcare industry and the increased complexity of those systems, the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated healthcare organisations on the EMEA’s proposed changes to EU GMP Annex 11.

In response to this and as part of an NHS at 60 campaign, Gael Ltd, a market leader in the design, development and delivery of compliance software, has created a white paper examining what the proposed changes to Annex 11 mean to EU GMP Rules and Guidance, and how it affects healthcare organisations.

The white paper will outline the proposed changes to Annex 11, highlighting what impact they will have on healthcare organisations, and how compliance is achieved. It will examine how these changes will affect those with computerised Quality Management Systems, and offer a proposed solution.

Martin Bowman, Sales & Marketing Director at Gael Ltd said, ‘We thought it was important to inform organisations of these proposed changes to EU GMP Annex 11 as many do not realise the impact they will have on their current systems. By reading the white paper, organisations will be aware of what they need to do to enable compliance with existing and proposed changes to GxP guidance.’

Request your copy of the white paper now, and please forward onto a colleague if you think it may be of interest.

For more information about how your organisation can achieve regulatory compliance and to discuss your future plans for Annex 11 compliant software for Quality Management, contact us now, or telephone +44 (0) 1355 593400.

Notes for Editors

Q-Pulse from Gael Ltd is a fully integrated compliance management solution that covers key regulatory functions such as Auditing, Document Control and CA/PA Management, in compliance environments.

Currently installed in over 250 NHS hospitals and departments, and internationally in companies such as, Astra Zeneca and 3M, Q-Pulse provides a single central environment for Healthcare Quality Management.

Contact Details – Michele Agnew, Marketing Manager,
Gael Ltd, Tulloch Gael, Scottish Enterprise Technology Park, East Kilbride, G75 0QR

T: +44 (0)1355 593400 F: +44 (0)1355 579191 E: W:

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