Computerised systems are widely used in the pharmaceutical industry for early development, clinical trials and manufactures. An effective CFR ensures that companies and organisations implement good business practices by defining the criteria under which electronic records and signatures are considered to be accurate, authentic, trustworthy, reliable, confidential, and equivalent to paper records and allows any handwritten signature to be replaced by an electronic one.

21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) guidelines on using electronic records and electronic signatures (ERES). The scope of 21 CFR Part 11 includes operational areas of pharma, biotechnology or medical devices company such as: — manufacturing, maintenance and laboratory. Leading pharma, drug discovery and development companies are aggressively investing in quality management systems through initiatives that assurance compliance with company and regulatory procedures and guidelines provide release and approval of all cGMP documentation, including Standard Operating Procedures (SOPs).

TEN CHAPTERS OF 21 CFR PART 11

SUBPART A - GENERAL PROVISIONS

Sec. 11.1 Scope

Sec. 11.2 Implementation

Sec. 11.3 Definitions

SUBPART B - ELECTRONIC RECORDS

Sec. 11.10 Controls for closed systems

Sec. 11.30 Controls for open systems

Sec. 11.50 Signature Manifestations

Sec. 11.70 Signature record/linking

SUBPART C - ELECTRONIC SIGNATURES

Sec. 11.100 General Requirements

Sec. 11.200 Electronic signature components and controls

Sec. 11.300 Controls for identification codes/passwords