Implementation of FDA 21 CFR Part 11 Regulations optimizes an organization's capabilities

Implementation of FDA 21 CFR Part 11 Regulations optimizes an organization's capabilities

Key Takeaway:

On the surface, FDA 21 CFR Part 11 regulations appear confusing, but following a risk based approach to computer systems validation sorts these out, increases the organization's computer systems efficiency and reduces costs

FDA 21 CFR Part 11 regulations have been codified to ensure that companies implement good business practices into their computer systems. Implementation of FDA 21 CFR Part 11 regulations into an organization's computer systems is a sure way of enhancing the efficiency of employees, identifying risks and thereby reducing errors, and thus increasing the productivity in the organization.

Outstanding features of FDA 21 CFR Part 11 regulations

Before the advent of electronic records and approval signatures; these were being done on paper. The purpose of FDA 21 CFR Part 11 regulations is to ensure that an electronic record that replaces a paper record and an electronic signature that replaces a handwritten signature have to be authenticated. Regulatory authorities have to be convinced that these digital formats are as authentic and trustworthy as the physical ones they replace.

• FDA 21 CFR Part 11 regulations are part of the Code of Federal Regulations (CFR)
• CFR contains laws that each government agency has to fulfill
• The CFR has several titles, and each of these addresses a designated, regulated area
• Critical areas of laws under the CFR relate to electronic records and approval signatures.

Three primary areas of 21 CFR Part 11 compliance

Compliance with 21 CFR Part 11 regulations consists of three core areas: