The pharmaceutical industry plays a critical role in our society. From research and development to production and marketing, many people are involved in the process of getting life-saving drugs to market.

Over the years, the pharma and life sciences industry has modernized itself through various technological advancements. These upgrades have been nothing short of a blessing, especially in difficult times like the COVID-19 pandemic.

With the rise of technology, it becomes imperative to ensure their safety and accuracy for patients and end-users. Computer system validation (CSV) plays a crucial role in it. CSV in pharma is purposed to ensure that a computer system performs according to pre-defined standards and processes.

What is CSV Validation in Pharma?

Here’s how the American FDA and UK MHRA have defined Computer System Validation (CSV):

“Confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”

In simpler words, Computerized system validation (CSV) is the process of validating a computerized system so that it consistently works to produce effective and safe results.

The FDA requires pharmaceutical companies to perform CSV for systems that are involved in the production of the following products:

  • Pharmaceuticals
  • Biologicals
  • Medical Devices
  • Blood and blood components
  • Human cell and tissue products
  • Infant Formulas

Why is CSV Validation Crucial in Pharma?

CSV Validation has become an essential part of the pharmaceutical and life-sciences industry due to the following reasons:

Compliance with legal requirements: Computer System Validation is a mandatory legal requirement. Companies can provide all required documentation to regulatory bodies after completing Computer System Validation.

Detecting system flaws can be life-saving: The software, hardware and digital processes used in the pharma sector impact the drugs and the medical devices produced. CSV enables companies to know any potential defects that could cause issues to patients.

Helps you avoid legal troubles: Having evidence that your computer system works as expected is helpful during inspections by regulatory bodies. It helps you avoid unnecessary lawsuits and legal procedures.

Boosts system efficiency: Validated systems can help companies improve the efficiency of their systems and processes. It can result in reduced labor and operating costs over the long term.

Constant performance enhancement: Companies that are constantly expanding and adding new features need to perform regular validation. It helps you prevent technical debt from building up.

What is GAMP 5 Computer System Validation?

GAMP 5, a Good Automated Manufacturing Practice Guide, is currently in version 5 and was published in 2008. It has been a revolution in Validating Computer Systems.

GAMP 5 computer system validation outlines the principles and procedures that ensure pharmaceutical and life science companies meet the defined quality standards. It also details a standard for Computer System Validation. A technical subcommittee within the International Society for Pharmaceutical Engineering sets guidelines for users and manufacturers of computer-based or automated systems in the pharmaceutical industry. It is being used as the main guideline for the pharma sector with regard to computer system validation.

These guidelines are based on the principle that quality can’t be tested in a single batch of products or devices but must be built into every stage of the manufacturing process. GAMP, therefore, covers all aspects of production, from raw materials and facilities to staff training and hygiene. GAMP 5 also covers electronic signatures and electronic records (ERES).

Sondagar Computer System Validation Services

Going through computer system validation by yourself can be challenging for most companies as they struggle to match the expertise and resources that go into CSV processes. That’s where we, at Sondagar Enterprise, come in.

We are a leading automated validation provider that has helped many pharmaceutical and life-science companies comply with stringent CSV requirements. Here’s what the portfolio of our computer system validation services looks like:

  • Automated Manufacturing Equipment (PLC / DCS / SCADA)
  • Line Automation (PLC / DCS / SCADA)
  • Process Automation Systems (PLC / DCS / SCADA)
  • Asset Management Systems
  • Building Management Systems (BMS)
  • Environment Monitoring Systems (EMS)
  • ERP Systems
  • Laboratory Management Systems
  • Document Management Systems
  • Quality Management Systems

Our highly experienced and passionate engineering team can help you stay compliant with a wide range of computer systems such as ERP, LIMS, LIS, EDC, eQMS, laboratory instrumentation, and other business information systems.

Leave your CSV troubles to us. Get in touch with us for a free consultation today!