Automation
Difference Between 21 CFR Part 11 and Annex 11
Chief Pharmacist
21 CFR Part 11 and Annex 11 are both regulatory guidelines that provide requirements for electronic records and electronic signatures ...
Software Development Life Cycle in Pharmaceutical Industry
Chief Pharmacist
In the pharmaceutical industry, the software development life cycle (SDLC) consists of several phases that ensure the proper development, validation, ...
Computerized System Validation (CSV)
Chief Pharmacist
Computer system validation (CSV) is the process of documenting that a computer system meets a set of defined system requirements. ...