We can define the validation approach and methodology to be followed, establish document deliverables, specific responsibilities for the departments/personnel, and completion criterion during the lifecycle for the implementation and
maintenance of your computerized systems
• Documenting the intended use of the computerized system(s)
• Assessing the compliance and business risks
• Demonstrating adherence with applicable regulations through objective evidence
• Ensuring the system’s integrity throughout testing
• Establishing operational controls necessary to maintain the systems in a validated state
We are here to help with the validation of software, both Commercial off-the-shelf (COTS) and custom-developed applications that interact with regulated operations or provide data or reports that are reported to regulatory agencies.