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Computer system validation or CSV validates automated systems and provides producers of pharmaceutical products the security that their computer-operated processes and systems function in a consistent manner and in accordance with the valid regulations.

Computer system validation practice

Automated systems within the pharmaceutical industry must comply with strict regulations, including USA FDA 21 CFR part 210, 211 and 11, GxP and EU GMP volume 4, annex 11. This is essential in order to prevent deviations during a later stage of the system development life cycle (SDLC) and to ensure a solid quality, security and operational reliability.


The objective of automated system validation, also known as computer system validation or CSV, is to ensure that an automated production system or process will deliver a specific result or product in a consistent manner, which complies with the predetermined specifications and quality requirements, and that this is fully documented.

In general, computerized system validation includes five phases:
  • validation master plan (VMP): documents the validation strategy
  • Design qualification (DQ): defines the system requirements and specifications
  • Installation qualification (IQ): verifies the installation requirements and design specifications
  • Operational qualification (OQ): verifies the functional specifications
  • Performance qualification (PQ): validates the user requirements

Brisk Technovision PVT LTD.

  • 20 years plus in corporate IT services
  • Employees around 150
  • Office in Mumbai, caters PAN India
  • Servicing Pharma Companies for 2 decades
  • Created New Division for CSV Services for Pharma Companies
  • Already completed many Projects in the new Domain
  • and having more projects in the pipeline.

Present Skills

  • EMPOWER Validation
  • PLC Validation
  • Instruments Validation
  • Instrument Software Validation
  • Having their own Tools & Instruments & CSV Formats for MOST Pharma Requirements that are must for FDA Regulators across the World. (US FDA, UK FDA, etc.)