Computerized System Validation
A great experience in qualifying pharmaceutical equipment and systems
Currently most of the pharmaceutical equipment is managed and controlled by computerized systems that have to be designed, developed and validated according to stringent quality standards defined by International Regulatory Bodies and Organizations like FDA, ISO and GAMP. Quality requirements impose the need for specific controls and procedures throughout the Software Development Life Cycle and the documented evidence, as stated by FDA, that “Computer Systems will consistently produce results that meet its predetermined specification and quality attributed”.
Acting in compliance with the most updated regulatory normative requirements, DOC has the Know-how and the Expertise to plan and execute Static and Dynamic Testing necessary for a successful Computer System Validation.