Anyone involved in medical device manufacturing knows that their industry is highly regulated. Almost every medical device manufacturer or pharmaceutical supplier uses materials testing systems in their quality control and research laboratories or outsources their testing to approved third-party laboratories. Though there are several different regulatory standards that testing laboratories often need to meet, the two most common are 21 CFR Part 11 (Electronic Records; Electronic Signatures – Scope and Application) and 21 CFR part 820 (Quality System Regulation/Medical Device Good Manufacturing Practices). Although these standards have broad-ranging requirements, materials testing suppliers offer products and services that focus on the specific elements associated with testing in these regulated environments.
21 CFR Part 11 was first introduced in 1997. Although comprehensive, the standard created a great deal of tension within the medical device and pharmaceutical industries, with the most common concern being the potential cost of achieving compliance. Furthermore, there was considerable confusion regarding implementation processes and procedures. Several guidance documents were written by the FDA in 1999 (Guidance for Computerized Systems…), 2003 (Guidance for Industry Part 11, electronic Records: Electronic Signatures), and 2007 (Guidance for Computerized Systems replacing the 1999 version) in hopes of clarifying the situation.