We offer a full suite of validation services to meet Health Canada, FDA, ICH and many European Standards to include:

• Process Validation and Validation Master Plan

• Warehouse Validation

• Cold/Wet/Dry Room Validation

• Refrigerator/Freezer Validation

• Incubator and Oven Validation

• Laboratory Instrument and Equipment Validation

• Computerized System Validation

We offer process validation services for EU-GMP to confirm through documented evidence that your manufacturing processes consistently produce a product to meet pre-determined quality attributes. This includes process design, process qualification, and continued process verification.  This rigorous validation process ensures your processes comply with EU-GMP regulations guaranteeing the safety, quality and efficacy of the medicinal product.

EU-GMP standards require that equipment be verified that they function as per their intended use and performing consistently.  The qualification includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

Think of Computerized System Validation (CSV) as a thorough checkup for the software that runs your critical operations. It makes sure your systems are reliable, produce accurate data, and meet strict regulations. This helps protect your products and keep your customers safe.