GAMP Sciences offers a complete suite of Computered System validation and compliance services led by a core team of highly qualified, scientifically trained Control System Validation specialists capable of delivering:

  • Process control systems
  • Manufacturing equipment
  • Water Systems
  • Manufacturing Execution systems
  • SCADA Based System
  • DCS Based System
  • PLCs Based System
  • Automated packaging equipment
  • Labeling equipment & Packaging System
  • Visual Inspection System
  • Building management system
  • Environment Management System
  • FMS
  • Track and Trace System
  • Robotic system

Our Approach to Implementing a Compliant CSV Program

  • Supply a standard suite of Software Quality Assurance SOPs, such as Risk-Based Validation, System Change Control, Incident Management, and Internal Audits
  • Adapt the standard SOPs to integrate with your existing SDLC, QMS, and technologies
  • Provide a standard suite of Software Validation Templates, such as the Validation Plan, User Requirements, Test Protocols, and the Validation Report
  • Train your staff in the use of the Software Quality Assurance SOPs and Validation Templates
  • Deliver ongoing support throughout your first validation project with training Module.
  • Dramatically shortened timeline for developing your computer system validation methodology and software quality assurance processes
  • Confidence that your validation approach meets industry standards and will withstand the scrutiny of regulatory inspectors and customer audits
  • Reassurance that your staff has been trained in best practices and is capable of successfully validating your systems
  • Conduct gap analyses of your systems against regulatory requirements (e.g., Part 11), and advise you on what to address first
  • Develop practical, customized, and appropriate approaches to your computer system validation (CSV) efforts and documentation
  • Review/revise your vendor qualification SOP
  • Bridge the gap between IT, business units, QA, and vendors by addressing expectations and responsibilities
  • Assess risks to data integrity as your data flow through your systems
  • Write validation plans and summary reports for your systems
  • Identify system relevance, system and vendor risk, and interpret audit findings
  • Provide validation document templates to make your processes efficient and repeatable
  • Work with your business units to define and document requirements for new computer systems