Validation and Qualification
"Outsource or in-source validation?"
It's a common question compliance executives face when a new validation project arises. There is no easy answer. Sometimes performing a project in-house just isn't feasible due to:
- Insufficient resources caused by diminishing departments,
- The high cost of production delays which could occur if the project stalls, or
- Lack of experience with the subject equipment or systems, especially when it comes to the requirements of Computer Systems Validation or satisfying 21 CFR Part 11 Electronic Signatures; Electronic Records.
Tanis Technical's team of expert Validation Services Specialists have world-wide experience helping our customers in the Pharmaceutical and Nutraceutical segments with their Validation challenges. Our breadth of experience in dozens of facilities around the world means we have likely validated your equipment or system previously.
We provide the following validation services, including protocol generation and implementation:
- IQ (Installation Qualification)
- OQ (Operation Qualification)
- PQ (Performance Qualification)
- CSV (Computer Systems Validation)
- FAT (Factory Acceptance Test)
- SAT (Site Acceptance Test)
We have strong partnerships with equipment manufacturers who service Life Sciences, giving us superior insight into equipment qualification requirements.
We cover the complete spectrum of equipment, including:
- Packaging Equipment (tablet counters, liquid fillers, cappers, vision systems, labelers, clamshells)
- Process Equipment (fluid bed dryers, spray dryers, coating pans, tablet presses)
- Utilities (USP water, DI water, Clean Dry Air, Dust Collection, HVAC, Gas Systems, Building Automation Systems)
- IT Systems (routers, servers/services)
We also generate all necessary compliance documentation including SOP, URS, FRS and DDS. Our extensive technical writing services save you valuable time – and money – and ensure that your systems’ validations and processes are always compliant.
Contact us to learn more about our comprehensive Validation services and Qualification services.
