Global Frameworks

Specialized Processing

Complete Verification

Implementation in strict compliance with Health Canada, FDA, and EU regulations, meeting Annex 11, Annex 22, 21CFR11, GAMP, and ISO standards.

Decades of direct expertise with PAT coupled with parametric release in terminal sterilization environments. We also have experience in filter-sterilized aseptic filling operations.

Full qualification lineage covering; Validation Plans Risk Assessments, URS, CS, DQ, FAT, SAT, IQ, OQ, and PQ documentation for complete regulatory audit readiness. We can also help with operational & maintenace SOPs and vendor qualification.

System Qualification Steps

Define & Specify (URS & CS)

Design & FAT (DQ & FAT)

Install & SAT (SAT & IQ)

Validate & Release (OQ & PQ)

Establishing precise user requirement specifications and configuration specs aligned with operational quality attributes.

Executing rigorous design qualification and factory acceptance testing prior to site delivery.

On-site installation and site acceptance testing protocols ensuring seamless mechanical and data integration.

Operational and performance qualification proving process requirements and continuous efficiency are satisfied.

Enhance Process Efficiency and Compliance

Share your process specifications with our validation team to design, configure, and qualify your automated system.