Regulatory and Compliance Business Process Management

Systematic Computer System Validation helps to prevent software problems from reaching production environments. Compliance to 21 CFR Part 11 brings significant benefits to Pharmaceutical companies by allowing them for electronic records keeping in GMP, GCP and GLP environment.
FDA regulations mandate the need to perform Computer System Validation and these regulations have the impact of Law. Failing an FDA audit can result in FDA inspectional observations (“483s”) and warning letters. As a component of Consent Decrees, the FDA may request the payment of fines and penalties.  These can run into the millions of dollars.  Individual members of a company’s management team may also be held criminally liable for the actions of their companies. 

Taking you from Business Process to Business Value

Pharmaceutical companies will always want to streamline the process of bringing new products to market, and manufacturing and distributing existing products. However they must also maintain and if possible improve the quality of the products and the processes that make them available for use, and comply with often demanding legislation, rules and regulations.
Achieving High Quality standards and using those standards to support the validation effort. Through the validation of a system and the implicit requirement to use a QMS from the beginning of a project and throughout the life of a system, an organization can reduce or eliminate the risks presented by their computer systems. Used in this way CSV can result in systems that are fit for purpose, satisfy users, are easy to support and maintain, and suffer less downtime. 

Project Transition Methodology
Governance Setup: Reviews the sales and contractual documents, statement of work (SOW), existing service reports and discovers the criteria by which the services included in the service delivery scope are measured.
Staffing:  Raise Resource & Service requisitions to respective providers. Acquire Resources & Services as per requisitions and associated commitments.
Process & Procedure: Establish the processes and procedures required for all parties to deliver the in-scope services. Identify Client's processes applicable to Service Delivery.
Knowledge Transfer: Transfer client-specific knowledge from the current service provider to the Capgemini delivery team.
Infrastructure: Review the technical environments and implement the internal environments/tools needed to deliver the service.
Shadowing and Reverse Shadowing:  Work based learning strategies.
Operational acceptance:  Testing looks at how the system will operate under certain conditions before Go live. 
Go Live

Our Services

Validation Consultancy
Execution of whole or partial validations including:
  • Gathering of User Requirements
  • Risk Analysis
  • Development of: Validation Deliverables like (i.e. VP,  URS, TM, IQ, OQ, PQ, VSR, CC, DC)
  • SOP's.
Quality & Compliance Management Compliance Assessments
  • GxP
  • 21 CFR Part 11
  • Internal
  • External
  • GAMP-Awareness
  • 21 CFR Part 11
  • Audit Readiness
  • Records Management

Why Capgemini? 

With almost 180,000 people in over 40 countries, Capgemini is one of the world's foremost providers of consulting, technology and outsourcing services. The Group reported 2014 global revenues of EUR 10.573 billion. Together with its clients, Capgemini creates and delivers business and technology solutions that fit their needs and drive the results they want. A deeply multicultural organization, Capgemini has developed its own way of working, the Collaborative Business ExperienceTM, and draws on Rightshore®, its worldwide delivery model.
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Rightshore® is a trademark belonging to Capgemini

Dedicated teams of fully qualified Computer System Validation Professionals with multiple country experience, based out of offshore Center.
  • Increase in Efficiency - Effective and Efficient utilization of resources
  • Utilization of best practices across regions and geographies
  • Terrific work ethic – deadlines have never been missed!
  • Process remedial works capability and Continuous Improvement methods

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