The US Food and Drug Administration's principal measure for regulating electronic records, FDA 21 CFR Part 11 holds companies to the highest and most stringent standards in documenting their processes and procedures.

In 1997, the FDA started an overhaul of its Good Manufacturing Processes. It was an effort that resulted, early in the 21^st century, of FDA regulation 21 Code of Federal Regulations (CFR) Part 11.

Previously, various efforts of FDA insiders (in addition to high-profile audit findings on computer system compliance) had resulted in many companies trying to fight rule enforcement that they were unprepared for – procedurally and technically. In fact, many software and instrumentation vendors released "Part 11-compliant" updates – only to be discovered that they were not really fully compliant. Because of complaints regarding wasted resources and confusion about the true scope and enforcement aspects of Part 11, the FDA released the FDA Guidance for Industry Part 11, Electronic Records: Electronic Signatures – Scope and Application. In May 2007, the FDA issued their final version of their guidance on computerized systems in clinical investigations.

FDA 21 CFR Part 11 requirements. This regulation requires that, in their use of technology, drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries adhere to certain standards and specific criteria in ensuring that their electronic records and electronic signatures are trustworthy, reliable and equivalent to paper records.

Part 11 demands that they implement controls, including audits, validation systems, and documentation for software and systems involved in processing many forms of data as part of business operations and product development.

One company that has taken this to heart is AlpVision. It just recently announced that AlpVision Krypsos™, an open platform to combat counterfeits, meets rigorous software and quality requirements of the pharmaceutical industry and health authorities.

A server-based online authentication system that only requires standard ink and standard printing processes (offset, rotogravure, laser, inkjet, etc.), Krypsos manages the Cryptoglyph packaging covert security solution as well as Fingerprint™, the AlpVision detection solution based on intrinsic characteristics of the product.

The Krypsos solution enables branded product manufacturers to provide their supply chain with a single point of contact for both fraud detection and genuine product authentication. It also provides valuable logistics data, such as gray market consolidation, and can generate helpful online notifications for mobile commerce.

In anticipation of major deployments which will bring covert protection to over a billion products worldwide by the first quarter of 2008, AlpVision Krypsos has achieved compliance with the FDA 21 CFR Part 11 requirements for Electronic Records and Electronic Signatures (ERES) issued by the Department of Health and Human Services of the US Food and Drug Administration (FDA).

This means Krypsos meets FDA regulation’s requirements by providing the following functionalities:

·         Audit trail documentation

·         Electronic records

·         Advanced security controls and password protection

·         Event reporting and notification, including times, actions, users and more

·         Central data storage in a single SQL database

The Computer Systems Validation (CSV) was performed in compliance with the V-Model, which defines the relevant project documentation under the supervision of either the customer or AlpVision.

AlpVision also has a comprehensive Quality Assurance (QA) system in place that includes development standards, document management, operational handbook, network and security management, risk analysis and contingency planning.

Setting an example. If “quality is job one” can be translated in the world of security solutions, then AlpVision Krypsos’ achievement – mastering complex software development in compliance with stringent QA standards established in the environment of large multi-national firms – can  certainly be an example.

 A steady flow of new anti-counterfeiting technologies achieving FDA 21 CFR Part 11 compliance can only benefit the customer and propel the IP agenda faster toward success.