Gael News

Today, we announced the release of the latest version of our compliance management software. Q-Pulse is an integrated compliance management solution that helps Life Sciences organisations to proactively manage regulatory activities such as Auditing, Document Control and CA/PA in compliance environments including GxP and ISO.

Q-Pulse Version 5.2 provides enhanced functionality that helps organisations in the Life Sciences sector to comply with the US Food and Drug Administration’s (FDA) 21 CFR Part 11 requirements for electronic records and electronic signatures, by enabling detailed audit traceability and electronic record and signature management.

In addition, Version 5.2 expands Q-Pulse’s web functionality with point-of-need access to Documents, CA/PA and Audit records through a secure web interface, offering centralised and customisable access to compliance activities and actions in all areas of the organisation.

Our customers in the Life Sciences sector require high levels of traceability to comply with 21 CFR Part 11,’ said Paul Callaghan, Gael’s Product Director, ‘and Q-Pulse Version 5.2 delivers enhanced functionality for electronic records and signatures, from robust passwords, intruder lock-out and password expiration, to additional electronic signatures and a full audit trail in creating, editing and deleting records.

Users can now more easily control the conditions under which they should receive email notification of activities and actions with conditional messaging. Users can also access overdue or upcoming actions directly from notifications, with enhanced email integration that closes the loop on messaging to encourage ownership and interaction throughout the organisation.

"Q-Pulse now gives Life Sciences organisations all the technical controls required to put a 21 CFR Part 11 compliant system in place," said Martin Bowman, Gael’s Sales & Marketing Director, "Version 5.2 will help organisations to move their management systems to one central streamlined system, laying a foundation on which they can build the administrative and procedural controls for compliance with 21 CFR Part 11."

In addition, Q-Pulse is a cost-effective solution for the Life Sciences sector that is available at an extremely competitive initial outlay compared to functionally similar systems, which increases resources available for implementation and training.