Document management aids FDA compliance

Edited by the Engineeringtalk editorial team Aug 28, 2006

Cyco Software has teamed with a global alliance of its solution partners to promote the new Cyco AutoManager industry module for the pharmaceutical industry.

Cyco Software has teamed with a global alliance of its solution partners to promote the new Cyco AutoManager industry module for the pharmaceutical industry.

Developed by DataCore Technology, the out of the box FDA module provides the technical controls needed for compliance with FDA 21 CFR Part 11 to properly manage cGMP engineering documentation throughout the enterprise.

Major global pharmaceutical companies have selected Cyco Software's solutions to bring products to market faster.

This boosts revenue and reduces costly errors while enhancing compliance with FDA Rule 21 CFR Part 11 and other government regulations.

"Cyco Software delivers solutions that enable organisations to access up-to-date engineering information anywhere in the enterprise at any given time", says Bert Janssen, Vice President of Sales, EMEA.

"The FDA module for the pharmaceutical industry is a proven business solution that adds specific features to our core technology that enhance compliance effectiveness, reduce validation efforts and improve document workflow throughout the enterprise".

DataCore Technology, a long-standing Cyco Software solution partner, developed the FDA module for the pharmaceutical industry to address specific data management needs among pharmaceutical customers.

The module provides the technical controls needed for complying with FDA 21 CFR Part 11, including audit trails, electronic signatures, workflows and lifecycles, controlled printing and bullet proof security.

A global alliance of Cyco Software solution partners, including Fenix Consulting, UK, Pentagon Solutions, Ireland, MicroPartner, Denmark, One Team, Italy, and DataCore Technology, USA, will now offer the FDA module to customers worldwide.

DataCore Technology trained this select group of resellers to provide expert consulting services in combination with the software technology.

Consulting activities include working with the complete lifecycle and validation documentation templates that are available to help validate the system, drastically reducing the time and cost of validation.

Fenix Consulting in the UK is one of the Cyco Software Partners that is offering the FDA module to its pharmaceutical clients.

"The team at Fenix has worked very successfully with a number of pharmaceutical clients in the UK for over 10 years".

"The FDA module brings an extra string to our bow, which has been immediately well received within our client base", says Brian Robertson, President of Fenix Consulting.

"For these clients, they can now see that Cyco AutoManager Meridian can be implemented at a range of levels, from low to high level, and even if they chose not to adopt the FDA Module initially, they have the comfort to know that Cyco AutoManager Meridian is a solution that they can grow into".