Qualsys provides FDA compliant document management services to support BT contract with Novartis
Earlier in the year, BT plc, the UK-based leading provider of communications solutions serving customers throughout the world, validated Qualsys' EQMS systems for 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, including Novartis, the Basle-based global pharmaceuticals giant. BT quickly introduced EQMS as the mechanism for controlling and sharing contractual documentation with Novartis. "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 has now enlisted Qualsys’s help to build and maintain the system over the next twelve months. Qualsys will optimise the configuration of EQMS to ensure that content is compliant, not only with the stringent requirements of the FDA’s CFR 21 Part 11, but also with BT’s own internal standards. “Qualsys has the unique combination of expertise in document control and experience in compliance with FDA regulations. We are pleased to have them on board as part of our team.” said Lori Mariano, Document Manager for BT’s Compliance Office based in Princeton NJ.
For information about Qualsys contact Robert Oakley on +44 (0)114 282 3338.
Email robert.oakley@qualsys.co.uk
16th September 2008
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