The FDA requires Good Manufacturing Practice (GMP) to ensure that products manufactured by the pharmaceutical industry meet its quality requirements. GMP regulations are specified in 21 CFR Part 210 (Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General Part) and 21 CFR Part 211 (Good Manufacturing Practice for finished Pharmaceuticals).In order to ensure compliance with the GMP standards, companies are required to record, monitor, manage and store a range of production documents and their version history:

• Standard Operating Procedures
• Master Production Batch Record
• Production Batch Record
• Equipment Log Books

Historically, companies retained all quality documents on paper in order to ensure compliance with GMP the standards. The Code of Federal Regulations (CFR), Part 11, was implemented in 1997 to authorize the FDA to accept electronic records and signatures in place of paper documents and handwritten signatures in order to check document validity.

Since then, 21 CFR Part 11 has set out a number of requirements (reliability, authenticity and permanence) for electronic data processing systems such as software, applications, and databases. These requirements must be met in order to achieve compliance.