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The Year 2000 came and went without too many catastrophes, even though at the time Y2K compliance was the theme on everyone’s lips. And as industry breathes a sigh of relief – glad that they have escaped that potential nightmare – another challenge emerges to take over as a main concern for many organisations; primarily those companies that develop new food and drug products for human consumption. That challenge is the complexity of ensuring 21 CFR Part 11 compliance.

The regulation has been in the draft stage for some time, but the final version is now enforceable. Section 21 Part 11 of the Code of Federal Regulations establishes the standards by which the Food and Drug Administration will accept electronic records and electronic signatures. The rule governs electronic records throughout their lifecycle from creation through modification, storage, and final transmission to the FDA.

With the aim of becoming 21CFR Part 11 compliant, many organisations are having to rethink their R&D or production processes and turn their attention to knowledge management and data security issues. In many cases the activities that were considered to be ‘normal’ practice before the rules came into existence will no longer be acceptable under the new regulations.

Important issues for compliance are the ability to identify anybody creating or modifying data records and the facility to track any data on its path through collection, creation, management and delivery to the end destination. Due to sheer quantities of information accrued year on year, for most organisations this implies the use of software and computer systems to provide adequate security, protection, and audit trails for collecting and managing data.

Some of the technical software solutions that can help your organisation work towards 21CFR Part 11 compliance are available from Adept Scientific plc. The full statements for each relevant product can be found at our website http://www.adeptscience.co.uk, but you can also find a summary below:

GRAMS/AI version 7
The latest version of this leading desktop spectroscopy software contains features to help your laboratory achieve a state of operation that is compliant with 21CFR Part 11. Proper use of GRAMS/AI 7 provides comprehensive audit logging, system security, and data security. And even if 21CFR Part 11 doesn’t directly affect your company yet, the features in GRAMS/AI version 7 are ideal for helping you comply with Good Laboratory Practices (GLP).

CambridgeSoft Chemistry Software
Chemistry applications, such as E-Notebook Enterprise and Document Manager allow for corporate knowledge management inline with 21CFR Part 11 regulations. So as any organisation reviews and updates its processes, the software can support this. Major requirements of 21CFR Part 11, such as electronic signatures, audit trails, and long-term archiving, are incorporated within the routine workflow to generate the critical information required by research, development and production.

NWA Statistical Process Control Software
When configured and applied correctly, NWA’s current products enable customers to meet the most important requirements of 21CFR Part 11, with full compliance across the product line expected by the end of 2002 or early 2003. These SPC products tend to be used as part of larger integrated information systems; so to be fully compliant the other aspects of your whole system must be equally geared inline with the new regulation.

The above software products are all supplied and supported in the UK and Ireland by Adept Scientific plc, Amor Way, Letchworth, Herts. SG6 1ZA; telephone (01462) 480055, fax (01462) 480213, email info@adeptscience.co.uk; or see Adept’s World Wide Web site http://www.adeptscience.co.uk/. Adept Scientific is one of the world’s leading suppliers of software and hardware products for research, scientific, engineering and technical applications on desktop computers.

With offices in the UK, USA, Germany and throughout the Nordic region, Adept Scientific is one of the world’s leading suppliers of software and hardware products for research, scientific, engineering and technical applications on desktop computers.