BT validates EQMS for FDA compliance
BT plc, the UK-based leading provider of communications solutions serving customers throughout the world, has concluded its validation process for Qualsys' EQMS systems. This process confirms that EQMS supports compliance with the Federal Drugs Agency's Code of Federal Regulations 21 Part 11(FDA CFR 21 Part 11).
BT has a growing client base in the Pharmaceutical and Medical Device sector, numbering global powerhouses such as Bristol Myers-Squibb and Novartis amongst its portfolio. "Strategic systems provided to these customers must be fit for purpose and compliant with applicable standards and regulations " said Richard Lees, Head of Genesis eService with BT Global Services. Richard's team were guided through the Validation process by Qualsys consultants. "We were clear on what we wanted from EQMS and how we wanted it done. Qualsys provided assistance with documenting our specification, designing our systems and then facilitating our testing plan. This meant that Validation was completed in a few short weeks." said Lees.
"EQMS assists any Pharmaceutical or Medical Device business with cast-iron control over its documentation. Critical documentation such as Quality Manuals, Technical Specifications, Device History Records etc must be carefully managed to ensure compliance with FDA regulations. EQMS takes away all the administrative effort required to control this information and automatically produces the audit trails required to prove compliance." said Robert Oakley, Commercial Director at Qualsys.
"BT can now demonstrate a clear understanding of the compliance issues that impact this business sector and can deliver compliant tools that can be quickly and effortlessly validated." concluded Oakley.
For information about Qualsys contact Robert Oakley on +44 (0)114 282 3338.
Email robert.oakley@qualsys.co.uk
11th April 2008
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