Zenosis achieves 21 CFR part 11 Validation

We are pleased to announce that our world class regulatory & compliance training and knowledge support system has completed its rigorous compliance process.

We can confirm that the Zenosis system was developed and implemented in line with the following regulations and guides:

Code of Federal Regulations Title 21, Part 11, Electronic Records; Electronic Signatures.
PIC/S Guidance 'Good Practices For Computerised Systems in Regulated GxP Environments' (August 2003).
GAMP 4 – Good Automated Manufacturing Practice (ISPE, December 2001).
General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002).
EU: EudraLex Volume 4; Annex 11.
Current Good Regulatory Practices (cGxPs).

The final validation of this compliance process is just another major benchmark in the continual evolution and development of the Zenosis system, ensuring a world class solution for the demanding regulatory landscape that is the global life science industry.

Our solution is rigorous, able to record and manage training records and provide comprehensive training for staff of different skill levels and disciplines within your organisation. It incorporates the following vital components:

Instructionally designed e-Learning courses that ensure that the learning objectives of the organisation are fully met.
A growing international curriculum that is supported and endorsed by the appropriate industry experts, regulators and leaders in their fields.
An Ergonomically designed user interface, intuitive and flexible interface and navigational design that empowers users of all technical skill levels.
A highly secure infrastructure, including encrypted password access, back-up systems, powerful firewalls and disaster recovery services.
A robust support service, with analysts available online.
An administration and reporting interface that enables line managers to ensure that change management is facilitated and the system itself is being used efficiently within the organisation.

Around the world, thousands of Life Science professionals are experiencing a paradigm shift in the quality, efficiency and ultimately the performance of their training and knowledge support resources, by using the Zenosis system.

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