Computerised System Validation & Assurance

A wealth of experience

Providing support

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:

  • Computerised systems and IT Infrastructure landscape
  • Current ways of working
  • Organisational structure and roles
  • Current capabilities

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:

  • Leverage supplier effort
  • Scope the validation based on GxP functionality
  • Scale documentation and records according to system complexity and software characteristics
  • Align validation activities with vendor approaches
  • Utilising application lifecycle management tools and test tools
  • Embracing automation (in particular, for IT Infrastructure)

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:

  • Supplier Assessment
  • Validation Plans
  • User Requirements
  • Functional Requirements
  • Risk Assessment
  • Design Specification
  • Test Plans
  • Test Scripts
  • Test Execution
  • Test Reports
  • Data Migration Plans
  • Data Verification Scripts
  • Data Migration Reports
  • Validation Reports

Our consultants support and advise on the development of processes for maintaining the validated state. These include but not limited to:

  • Change and Configuration Management
  • User Access Management
  • Continuity and Disaster Recovery
  • Incident and Problem Management
  • Deviation and CAPA Management
  • Document and Records Management
  • Training
  • Periodic Review

Integrity provides a range of business-to-business training programs designed for both beginners and experienced practitioners.

These training programs address:

  • Principles of risk-based approach
  • Supplier assessment
  • Validation lifecycle activities
  • Operational controls
  • System retirement
  • IT Infrastructure Management and Control

Our consultants support internal audits, project audits, periodic reviews, and maturity assessment programs to evaluate the current validated state of GxP computerised systems.