What We Do
Commitment to Compliance
SSS delivers comprehensive consultancy and validation services to Pharmaceutical, Biotech, Medical Device, and Healthcare industries, ensuring compliance with global regulatory standards such as USFDA, EU-GMP, MHRA, WHO-GMP & 21 CFR Part 11.
We support customers with end-to-end qualification, validation, and third-party regulatory services.
SERVICES
COMPUTER SYSTEM VALIDATION (CSV)
- GxP software validation (ERP, LIMS, MES, SCADA, PLC, BMS etc.
- URS → Risk Assessment → IQ/OQ/PQ → Traceability → Final reports
- Data integrity audits (ALCOA+
- 21 CFR Part 11 / Annex 11 compliance
EQUIPMNET QUALIFICATION
- Installation, Operational & Performance Qualification (IQ/OQ/PQ)
- Qualification of manufacturing, packaging, laboratory, and utility equipment
- Lifecycle documents: VMP, FAT/SAT, Validation Protocols & Reports
PROCESS VALIDATION
- Stage 1: Process Design | Stage 2: PQ | Stage 3: Continued Process Verification
- Cleaning validation & verification support
- Risk-based sampling & acceptance criteria
HVAC & CLEAN ROOM QUALIFICATIONS
- Air flow pattern study, particle count, pressure differentials
- Recovery time, filter integrity (HEPA validation)
- Room classification ISO & EU GMP standards
VENDOR & COMPLIANCE AUDITS
- Supplier audits for RM/PM, APIs, service providers
- Gap assessment & CAPA effectiveness
- Ongoing vendor performance evaluation
TEMPARATURE MAPPING & THERMAL MAPPING
- Warehouse, cold rooms, stability chambers, transport vehicles
- Real-time monitoring setup & qualification reports
- Autoclave qualification and Validation