FDA Validation & 21 CFR Part 11 White Papers and Technical Articles

Articles relating to FDA Validation, 21 CFR Part 11, Electronic Records, and Electronic Signatures as they relates to automation, process control, and instrumentation applications.

About 21 CFR Part 11 Electronic Records; Electronic Signatures

The pharmaceutical, biotech, and medical device industries have become dependent on computerized systems for every aspect of a drug's lifecycle. Clinical trials are managed using software; New Drug Applications are submitted to the FDA electronically; laboratory assays on a drug's efficacy are performed using computerized instrumentation; and critical parameters in the drug's manufacturing process such as temperature and pH are controlled using automated systems. Labeling, adverse reaction reporting, consumer complaints, and pharmacy controls also depend on various computer systems working perfectly. All these systems now fall under the jurisdiction of 21 CFR Part 11. More Info...

Data Acquisition For Controls and Instrumentation In 21 CFR Part 11 Applications

Regulations pertaining to electronic records and signatures are incorporated into Title 21 of the Code of Federal Regulations Part 11 (21 CFR Part 11)1. This paper explores the effects 21 CFR Part 11 requirements can have for data recording within regulated applications in general and within sanitary environments (pharmaceutical, biotechnology, and food & beverage) in particular.  Read complete paper by Ravi Jethra of Endress+Hauser.

Validation of Automated Systems

Computer technology has changed the framework of business in every industry, transforming the way the businesses operate internally, as well as they interface with customers and external businesses. More Info...