Computer System Validation (CSV)
Wipro has developed a Computer System Validation (CSV) methodology, which centers on the FDA, GAMP4 computer validation guidance. Our critical objective is to meet all regulatory constraints associated with a computer system validation, as painlessly as possible, by utilizing a risk-based approach and generating the optimum documentation. The quality of our service helps lowering risk and helps ensure that all projects cost-effectively meet your validation requirements.

21 CFR Part 11 Compliance
Wipro has extensive experience in implementing the requirements of 21 CFR Part 11 in new as well as exiting systems. We provide consultancy services like gap analysis, risk assessment, and remediation plans for helping life sciences clients to be compliant with the regulations.

Regulatory Best Practices Consulting (GxP)
Wipro helps customers to implement best practices in the areas of manufacturing (GMP), clinical research (GCP), laboratories (GLP) and IT governance (ITIL) through a standardized and proven methodology. Our consultants ensure compliance to the regulations and guidelines using various tools such as risk assessment plans, checklists, validation protocols (IQ / OQ / PQ protocols), traceability / functionality matrices, etc. In addition, we provide consulting services in the areas such as manufacturing process automation, document / record management, clinical trial data handling and submission.

HIPAA Compliance
Wipro enables compliance to HIPAA regulations by focusing on system / environment assessment, analyzing security and transaction gaps and providing suitable remediation. We also provide the security framework design for a HIPAA compliant system development and implementation.

Medical Devices Validation Services
Wipro offers full range of medical device regulatory service offerings to cover the entire life cycle of a medical device right from the concept phase through post marketing compliance. Our services cover regulatory impact assessments, compliance with quality system regulation, product verification / validations, field complaint handling, and Corrective Action Preventive Action (CAPA) programs.

SOX Compliance
With its structured and modular approach and methodology, Wipro assists clients to overcome the challenges, design document / test IT internal control framework, establish monitoring mechanism and comply with SOX (Section 404) requirements. Wipro also provides end-to-end solution or can partner with the client for any specific area(s) wherever the need be.

ePedigree Consulting
Federal regulations (Prescription Drug Marketing Act 1987, FDA 21CFR Part 203.50) and state regulations (Florida, California) have created an urgent necessity for the companies to implement electronic pedigree across the pharmaceutical supply chain.

In order to ensure the right solution, Wipro provides process and technology consulting. This ensures that the customer is clear about key value drivers underlying the ePedigree initiative.

After an in-depth feasibility study, we provide a comprehensive roadmap for ePedigree solution and implementation.