Managing the many regulatory demands involved in the validation process often leads to significantly increased project costs. To simplify the process while ensuring full compliance with all regulatory requirements, we take a well-defined approach based on LEAN principles.

From the initial analyses until the system is live, we follow LEAN principles and wherever possible make use of our in-house off-shoring resources to reduce the time and costs involved. Our team of validation experts is experienced with all aspects of the process – from process consultancy to project management. Furthermore, we draw on our extensive experience to prepare validation activities on a need-to-have basis which makes the process faster, as well as significantly more cost-effective.

The benefits of using LEAN principles when working with validation include:

• Shorter system implementation time
• Fewer resources required
• Reduced fail rate due to process control
• Less regulatory risk
• Consistent quality through standardised templates and processes
• Improved overview of the validation process
• Aligned approach for new IT systems integration or upgrades