Test, validate and document according to current compliance best practices.

Computer System Validation (CSV) is required by regulatory agencies to verify that a computerized system consistently works as intended. CSV is not a one-and-done process. You must assess revalidation every time you make a change to the system or software, then document these activities and any test results associated with the change.

CSV can be costly and time-consuming, particularly if you’re validating on paper and haven’t adopted a risk-based approach to determine the appropriate level of testing and documentation required to meet regulatory expectations. Due to its complexity, CSV is best suited for high-risk systems that directly impact patient safety or product quality. If a system is deemed low- to medium-risk, Computer Software Assurance (CSA), a simplified method for performing CSV, can reduce project costs and accelerate time to market. Unfortunately, if you’re validating on paper, any potential efficiency gains from CSA will be lost.

CSV improves the efficiency of handling unexpected complications as well as the overall performance of the system.

Good Automated Manufacturing Practice (GAMP 5) is a set of standardized guidelines that breaks down the computer system validation process into specific life cycle phases, with each life cycle containing particular activities. The pharmaceutical industry widely uses GAMP 5 computer system validation to adequately satisfy the FDA’s criteria described in FDA 21 CFR 11.

FDA 21 CFR 11 describes specific controls that regulators need to see about each computer system. GAMP 5 provides actionable steps to achieve those controls.

The four GAMP 5 life cycle phases include:

1. Concept: A high-level understanding of the specific system
2. Project: A detailed description of the system and its objectives
3. Operation: How is the system managed while in operation?
4. Retirement: How is the system retired?

Namely, the benefits of CSV in the pharma industry go as follows:

1. Legal compliance with the FDA — after completing Computer System Validation, companies will be able to provide regulatory organs with all the needed documentation;
2. Reduces compliance risks. Having empirical evidence of the fact that the system works as expected comes in handy during the inspections from regulatory organs.
3. Discovers defects before a system build goes live. This way, pharmaceutical companies can avoid image losses or fraud.
4. Provides companies with continuous improvement. Validation is a necessity for companies that constantly scale and add new features as it allows the development team to prevent tech debt from piling up.
5. Maximizes system efficiency. If companies have validated systems, a business manager increases its future value and the efficiency of employers that use it. In the long run, CSV reduces both operating and labor costs.