Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Regulation 21 CFR Part 11 and Aspects of Computer Systems Validation for Pharmaceutical Companies ***

Peter Frank Eggen (Abschlußjahr: 2002)

The computer technology has fundamentally changed the entire framework in almost any industry, transforming the way how the business will operate internally as well as externally, the way how companies interact with their clients and partners, their suppliers and - if regulated - with their regulators.

Computer technologies serve in two fundamental domains. First, they fulfill functions in real time process automation and control as well as in the management of human workflow and interaction. The second primary domain where computer technologies are getting used extensively is in the area of information management. Especially this area has significantly suffered from the rapid pace the computer industry is moving. The rapid growth of computer technology has rendered many electronic data and information - created just a decade ago - to be meaningless and inaccessible for the next generation of computer systems

The idea to move over to a paperless office has been raised many times in history, especially when new electronic successes have been celebrated in the past. On the other hand, the same idea has also been feared in the light of new challenges like information reliability, authenticity, long-term accessibility, usability and privacy. Without an appropriate legislative framework in place setting standards for electronic data reliability, authenticity, accessibility, usability and privacy this idea would never get realized.

In August 1997, the FDA has enacted 21 CFR Part 11 to set out the conditions under which it will accept electronic records and electronic signatures to be the legally binding equivalent for paper documents and handwritten signatures. For FDA regulated companies this is a tremendous opportunity to be able to react quicker and being more accurate than it would be supported by legacy paper environments.

However, this transition is not without any challenges, risks and costs. In order to be eligible to operate electronically, organizations must proof that their processes, their systems and their people are appropriately qualified for the electronic environment. Therefore organizations need to carefully plan for their 21 CFR Part 11 activities and need to establish a corporate program for it - like it has been done being faced with the millennium issue. Unlike Y2K initiatives, 21 CFR Part 11 programs are perceived as being even more difficult and challenging, because of being faced with dynamics such as changes to the business, technology or regulatory environment.

This master thesis discusses the various implications of 21 CFR Part 11 as well as certain pitfalls of the ruling. In addition to that, it provides organizations with a methodology to be followed, which could help to absorb some of the dynamic changes caused by business or regulatory framework changes.

Furthermore it discusses implications of product development suitable for GxP environments as well as aspects of computerized systems validation, which are mandatory required for systems to be used in context of 21 CFR Part 11.

FDA has taken a bold step in establishing one of the first regulations to define legal conditions in context of electronic records and electronic signatures. The same is likely to appear in other countries around the world sharing the same demand for legislative frameworks allowing for being able to move onto an electronic environment with paper no longer being necessary.

Pages: 97