Computer Systems Validation in Life Sciences

Computer system validation is an essential component of risk management in life sciences manufacturing. No software is guaranteed by its manufacturer to be flawless. The more complex the software becomes, the more likely the existence of errors becomes. It is prudent business practice to demonstrate to regulatory bodies and customers that the existing computer systems perform their intended functions both operationally and functionally in pharmaceutical and medical device production. This is the foundation for computer system validation in life sciences.

Life sciences validation software is required by FDA regulations and international quality standards, including: 21 CFR Part 11, 21 CFR Part 820, ICH Q9, ISO 13485:2016, and European Union's Annex 11. MasterControl's life sciences validation software assists companies in meeting these requirements efficiently and effectively.

Key aspects of computer system validation in life sciences environments include:

The importance of computer system validation in ensuring product quality and patient safety.

The FDA's expectations regarding computer systems validation in pharmaceutical and medical device manufacturing.

The utilisation of risk assessment in computer system validation for life sciences.

Potential cost savings that can be derived from vendor validation documentation in the life sciences industry.

Commercial off-the-shelf solutions that can reduce computer system validation time and costs for life sciences companies.

MasterControl's life sciences validation software offers practical strategies for reducing computer systems validation time and costs in pharmaceutical, medical device, and biotech manufacturing. It provides a proven risk-based approach to computer systems validation tailored to the specific needs of the life sciences industry.