Having more than a decade of experience in helping our healthcare and life sciences customers design, develop and market their products, gives us the very important insight into how our teams function and the challenges faced by them, like - meeting the time-to-market pressures and demands of the regulatory agencies with added complexity for addressing the local regulations while expanding into emerging markets. Regulatory Services from Wipro are designed to help our customers address these issues and to standardize and improve the Verification & Validation (V&V) and compliance processes.

We are regulatory compliance experts, and have extensive experience in systems & process validation life cycle management and implementation in compliance with global regulatory requirements, including FDA 21 CFR Part 820 QSR, IEC 62304, ISO 14971, FDA 21 CFR Part 11, US HIPAA/EU Data Privacy Directives and 93/42/EEC (MDD). We are certified for ISO 13485 by notified body.

Wipro has developed a lean, structured, mature and scalable Global Compliance Support Framework that helps our clients meet their regulatory schedules and budgets by utilizing a "Risk-Based, Right Size" approach to compliance, ensure any system or equipment developed/ deployed are compliant with applicable regulations and stand up to any regulatory body inspections.

We offer whole gamut of services including strategic consultancy, tactical services, and validation outsourcing. Our services in the quality and regulatory area encompass:

Quality Assurance & Regulatory Affairs (QARA) Consulting
  • Pre Market Submissions - FDA 510(k), PMA, CE Marking, CCC, MHLW etc.
  • Quality & Regulatory Remediation Services:
    • Implementation of Quality Management System (FDA QSR / ISO )
    • Gap Analysis with regard to regulatory compliance
    • Corrective Action/Preventive Action (CAPA)
    • Supplier Engineering
    • Post Marketing Surveillance Activities
  • Audits and Assessment Services, including
    • Quality Management System Audits / Mock Inspections
    • Vendor Audits
    • Training
  • Strategic IT/IS Compliance Consulting
    • Compliance Gap Analysis & process improvement
    • Implementation of GAMP5-based process model for Compliance
    • Streamlining and harmonizing validation processes and deliverables across multiple sites
    • Data Privacy and Protection (US/EU)
    • Creation of central system inventory and portfolio analysis based on GxP relevance
    • Development of SOP's and process guidelines

Design QA and Compliance (DQAC) Services

Computer Systems Validation & Compliance (CSVC) Services
 
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Jyotirmay Datta, Global Head Medical Devices, Wipro Technologies, talks about the key trends in the life sciences and the medical devices industry impacting the CFO organisations - elaborating on their impact on the healthcare ecosystem and, the opportunities for technology, to address some of the challenges that are an outcome of the change.
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