2012-11-13 13:27:26 - Secure, online and compliant training environment with traceable course participation unveiled
Notts., UK (13 November 2012) – Global compliance specialist GXPi has today announced the availability of its highly anticipated training platform – X-train™.
Built on the company’s X-docs™ platform, X-train™ has been designed to deliver automated and recorded training in an environment that will suit even the most regulated industries – such as life sciences or pharmaceutical sectors. The new system provides a range of options for positive measurement of competence and the ongoing management of training requirements on an individual and organisational scale.
X-train™ is expected to solve an age-old problem for compliance managers, as GXPi Product Director and Principal Consultant Jonathan Burd explains: “Many organisations operating in a regulated environment regularly have to demonstrate the competence of staff to
perform the tasks that they are recorded as undertaking. Auditors are particularly interested in following the trail back from a documented process to confirmation that the individual who undertook that process was certified as competent to do so.
“Traditionally this is managed through a range of paper and spreadsheet records distributed across the organisation, requiring the urgent ‘rounding-up’ of these records to meet the auditor’s requirements. X-train™ enables this information to be centralised, easily accessible and constantly maintained and updated as training and retraining takes place, driven from a staff profile and associated role-based training plan. This provides an efficient way of tracking training to meet both audit and resource planning needs.
“X-train™ creates a fantastic central resource for employee information capable of automatically distributing tasks, monitoring results and repeat cycles, and issuing certificates, training reports, retests and updates. Knowing the pain this causes within organisations we are expecting a lot of interest in this simple-to-use solution.”
GXPi has ensured that X-train™ will meet the needs of its customers by using their feedback at every stage of the development process. Real-life data sets, third party focus groups and anecdotal observations were all considered and used in the design, development and testing process, aimed at ensuring X-train™ is a well-rounded and comprehensive solution.
The resulting system is compliant with the training record requirements of the GxP good practice codes, as well as CFR 21 Part 11 and EU Annex 11 making it the ideal solution for deployment in the pharmaceutical and life science industries - as well as many other regulated environments where records of achievement are necessary to demonstrate compliance.
If X-train™ is teamed with X-docs™ for the management of controlled documents, automated alerts are instantly generated when documents like SOPs linked to training skills are changed, enabling the timely updating of the skill and significantly reducing the risks of falling into a non-compliant state.
At a recent event GXPi found that health authority auditors are looking for competency assessment rather than tick lists of ‘read and understood’. So with the provision of positive measurement of understanding being particularly important at this time, the new X-train™ system offers a number of stronger competence evaluation methods, including multi-choice tests and skill or management based assessments along with ‘read & understood’, which may still suit some training.
For more information on GXPi’s products and services go to www.gxpi.com. Or meet with them at the 13th DIA Conference on European Electronic Document Management on 28th November at Sheraton Munich Arabellapark Hotel Arabellastrasse 5 81925 Munich, Germany.