Access Control and Password Security Management in Pharmaceutical Industry

Abstract

Access Control and Password Security Management plays a vital role in most of the pharmaceutical industry. It is a critical requirement of electronic record compliance, as described in the Food and Drug Administration (FDA) 21 CFR part 11.10 (a) and European Medicines Agency (EMA) Annex 11, section 4.  Due to increasing scrutiny and inspection from the FDA and other regulatory bodies as well as need comply with the industry standards such as Good Manufacturing Practices (GMP), Good Distribution Practice Standards (GDP), Good Storage Practices (GSP) and other relevant standards set by the WHO. Therefore, pharmaceutical industry needs to implement and enforce consistent security practices. The purpose of access control and password management is to define minimum computer security requirements to protect application data and resources with respect to confidentially, integrity and availability for computerized systems. To lay down a procedure for access control and password security management of the equipment/instrument/system facilitated with password control. This is relevant to all the systems, software’s, programmable logic controllers and other electronic devices used in the pharmaceutical industry.