With 25 years-experience across clinical systems, manufacturing automation, laboratory systems, supply chain solutions, pharmacovigilance, quality systems and IT infrastructure (including cloud environments), Integrity is best placed to support your Computerised System Validation program.
The computerised system validation strategy establishes a balanced approach to quality and compliance by embedding a mindset of risk-based approaches supported by critical thinking.
Our consultants support the development of your computerised system validation strategy by understanding your:
Validation planning ensures a risk-based approach that’s based on patient safety, product quality and regulated data integrity.
Effective validation planning should seek to:
Our team of validation leads will ensure that all members of the computerised system project fully understand their roles and expectations.
Close collaboration with suppliers and system integrators is essential to ensuring synchronisation of solution delivery and validation activities. Early engagement will ensure everyone has a common understanding from the outset.
Identified risks and deviations are actively managed to avoid impacts to the overall program.
Our managed team will support the development of system lifecycle documentation including but not limited to:
Our consultants support and advise on the development of processes for maintaining the validated state. These include but not limited to:
Integrity provides a range of business-to-business training programs designed for both beginners and experienced practitioners.
These training programs address:
Our consultants support internal audits, project audits, periodic reviews, and maturity assessment programs to evaluate the current validated state of GxP computerised systems.