PRACTICAL IMPLICATIONS OF ELECTRONIC SIGNATURES AND RECORDS

David Selby Selby Hope International North Yorkshire, United Kingdom 

Such a momentous event should have lit up the pharmaceutical world, offering us the opportunity to increase the efficiencies of our development and manufacturing processes and the associated recording activities. At the same time, it offered the prospect of exchanging the mountain of paper, which has been associated with such activities, for much more compact and easily manageable electronic files. 

But it didn t. Instead, the new regulation has been the source of much debate, even furious argument. More than two years later, the argument still rages. Why Is this and what can we do about it  

Much dialogue took place between the industry and the FDA during the development of the rule, and the final result is better and more practical as a result. However, there are significant difficulties with the rule as it stands, particularly with its application to noncompliant electronic records generated with systems that were in place when the rule became law, the so-called legacy systems problems. 

---

Selby, D. (2000), Practical Implications of Electronic Signatures and Records, in Validating Corporate Computer Systems Good IT Practice for Pharmaceutical Manufacturers (Ed. G. Wingate), Interpharm Press, Buffalo Grove, IL. 

The final portion of the book looks at operational compliance. Supplier Audits and the practical implications of 21 CFR Part 11 (the use of electronic records and electronic signatures). 

---