Qualifications and Validations
Skandanana Pharma - Confidence beyond Compliance
Qualification and validation (Q&V) is one of our biggest areas of business. As a process primarily used within the biopharmaceutical & pharmaceutical industry, Q&V ensures systems, facilities and equipment meet the design standards required for the end user. We are an authority on industry standard validation. Our expertise allows us to offer a solution to all your validation needs.
- Equipment software Validation (PLC, HMI, SCADA, Network along with excel sheet & all types of Calculators of both soft & Physical units).
- HVAC Performance Qualification (PQ) and also execution of IQ & OQ Validation of New as well as existing Air Handling Systems as per Regulatory standards.
- Equipment Qualifications (IQ/OQ & PQ) of new and existing units as per Regulatory compliance or Client In-house approved procedures as applicable.
- Utilities cum Gases Ara Qualification as per best of industry practices.
- Development of URSs for facilities, equipment and utilities as per Clint Specific.