AUTOMATION AND
COMPUTERIZED SYSTEMS

Validera has more than a decade of theoretical and practical experience in the validation of computerized systems and has successfully completed several extensive assignments. Within this field we can offer a full service covering all possible requirements, including, for example:

• Expertise and knowledge on current regulatory requirements and guidelines such as GAMP5 and the implementation of these
• Plan and lead all validation activities within a project related to computerized systems, from design qualification to production start
• Develop Validation Master Plans and Master Reports
• Plan and lead risk assessment and software and hardware classification activities
• Develop validation protocols and reports for all kinds of computerized systems, such as: MES (Manufacturing Execution System), LIMS (Laboratory Information Management System), Automated and computerized systems used within (for example process equipment, HVAC and laboratory equipment), DCS and SCADA, IS/IT and administrative systems
• Execute validation activities from design qualification to process validation