Services
Our Services
System Validation
Equipment Qualification.
1. Complete Equipment, Facility, Utility Qualification life cycle (URS, IQ, OQ, PQ)
2. Quality risk management
3. Robust & Comprehensive documentation of validations
4. Gap Analysis & Regulatory compliance
5. Risk mitigation strategies
Computer System Validation
1. Targeted risk assessments & Risk based validations
2. Validation life cycle management
3. System specific validation plans, testing and reporting
4. Thorough test scripts, detailed documentation and reports.
5. Gap Analysis & Regulatory compliance
GMP & GEP Compliance Services:
1. Quality risk management services
2. CAPA Implementation and remediation
3. Risk based approach to validations
4. Gap assessment and remediation
5. PLC & SCADA Programming services
6. SCADA Upgradation services to meet with 21CFR requirements.
7. TPM (Total productive maintenance) methodology implementation
8. OEE (Overall equipment efficiency) methodology implementation
9. Temperature mapping services.
Industries Support
Pharmaceuticals
Biotech
Clinical
Healthcare
Medical Devices Industries