Wipro works with pharmaceutical clients to ensure they stay compliant and reduce operational inefficiencies. Our Compliance-as-a-Service (COMPASS) mitigates risk across the pharmaceutical value chain by addressing operations and product quality, infrastructure and applications portfolio, validation, regulatory information management and patient safety and pharmacovigilance. COMPASS provides:
- Computer System Validation (CSV) solutions that meet FDA and GAMP guidelines
- Pharmacovigilance (PV) solutions for safety monitoring and the timely generation, review, assessment and evaluation of Individual Case Safety Report (ICAR) and other aggregate reports
- Regulatory Information Management (RIM) services and drug safety services covering KPO, consulting, IT and analytics
Clients using COMPASS benefit from exceptionally well-managed and streamlined risk, compliance and safety processes.