Why computer system validation is very important?

You are working in Pharmaceutical/ Medical device company and heading the Quality, IT or Operations and accountable for the computer systems used in-house. Associating with these highly regulated industries means that regulators such as FDA, MHRA and TGA will scrutinize the use and validation of these computer systems. We will cover importance of Computer system validation, but first let’s understand computer system validation (CSV) in detail before explain importance of CSV.

Computer system validation (CSV)

Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements. But the FDA’s idea of validation is much broader than simply executing the software to validate output meets specification requirements (dynamic testing).

Computer System Validation in a GxP environment also includes static testing – inspections, walkthroughs, and other review/analysis activities that can be performed without actually running the software. FDA validation of computer systems includes all of these dynamic and static testing activities, with emphasis on producing documented evidence that will be readily available for FDA inspectors.

In addition rule 21 CFR Part 11 states that electronic records may replace paper records and these electronic records with electronic signatures are as secure as a handwritten signature. This rule 21 CFR Part 11 impacts all companies operating in GxP environment.

Computer system validation is a critical tool to assure quality of computer system performance. Importance of Computer system validation are many. It enhances the reliability of system, resulting in fewer errors and less risk to process and data integrity. It also reduces long term system and project cost by minimizing the cost of maintenance and rework.

Benefits of effective computer system validation

• Ability to provide all required documents readily by FDA, other regulatory agencies and your customers.
• Maximize the value of the computer system and the employees that use it.
• Reduce labor cost by enhancing employee efficiency and effectiveness
• Effective project management are scheduled on time and budget
• Save money and time by discovering defects at early stage.
• Reduces risk, legal liability, not regulatory, is often the most important reason to perform validation.
• Promotes continual process improvement.