Computerised System Validation

Broad experience in qualifying pharmaceutical equipment and systems

 

Currently, most pharmaceutical equipment is managed and controlled by computerised systems that must be designed, developed, and validated according to stringent quality standards. These standards are defined by International Regulatory bodies and organisations, like FDA, ISO, and GAMP. Quality requirements demand specific controls and procedures throughout the software development lifecycle, plus documented evidence, as stated by FDA, that “Computer Systems will consistently produce its specified results and level of quality'.

 

Acting in compliance with the most updated regulatory requirements, DOC has the knowledge and expertise to plan and conduct the static and dynamic testing necessary for a successful computer system validation.

For more information, please contact:

Manfredi