Qualification and Validation

If your infrastructure doesn’t meet regulatory standards, or isn’t robustly validated at each stage, compliance will become more difficult – and take longer. Galenisys can help your operational, engineering and quality teams establish strict new protocols for the qualification and validation studies of new and existing facilities, equipment, utilities and manufacturing processes.

These protocols will help ensure compliance with both industry and regulatory standards and assure consistent performance in everyday operations.

Galenisys can help you create:

• Master validation programmes
• Protocol definitions
• Qualification definitions
• Report formats
• Approval stages, responsibilities and processes
• Qualification studies for sterilisation equipment and processes
• Calibration programmes and methods

We can also help you ensure you meet your compliance targets through training, project management, quality audits and troubleshooting quality issues.