Computer system validation requires regulated companies to demonstrate that their computer systems work how they should. This includes software, hardware, and the physical barriers that prevent unintended access.
Look at the FDA’s library of Warning Letters to see why software validation is not taken lightly. It is crucial for your business.
What is Validation?
Computer system validation is a process of testing, certifying, and documenting that a regulated computer-based system does precisely what it’s designed to do. It also ensures that the system is reliable and secure.
Under FDA 21 CFR 11, ICH, EudraLex, and Good Automated Manufacturing Practice (GAMP) guidance, this is an essential requirement for all life science companies that produce pharmaceuticals, biologicals, excipients, human cell and tissue products, or medical devices—introducing the new guide that has refocused computer system validation on an agile risk-based approach to compliance.
What is the Purpose of Validation?
Validation aims to ensure that new and existing computerized systems meet their intended objectives, are fit for their intended use, and remain so throughout their operational lives. This is an ongoing and iterative process.
Validation involves testing all aspects of the system, including software and hardware. This can be done in several ways, using different methods and combinations of tests. This helps to ensure that no one part of the system is missed. Documentation is essential at all stages of the process.
What is the Goal of Validation?
Computer system validation (CSV) is critical to GxP compliance for pharmaceutical and medical device manufacturers. After all, a software bug can have disastrous consequences for patients and production.
CSV is a cross-cutting activity applied to every stage of the life cycle of a system. It begins at the concept phase with gathering data and a high-level project plan.
It continues through the design phase with a Functional Requirements Specification (FRS) and a Design Specification (DS). It then moves on to installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). All of which are documented and reported.
What is the Process of Validation?
Computer system validation is an ongoing activity, not a one-time event. It must be conducted when new software is installed, or hardware is upgraded and whenever changes to the existing functionality occur.
The level of validation needed depends on the software’s intended use. Software part of a production or quality system must be validated to a high level. In contrast, software not used in these systems only requires a lower verification level. This allows for a more streamlined approach to software compliance. It also reduces risk to the business.
What is the Measure of Validation?
Computer system validation ensures that new and existing computer systems consistently fulfill their intended purpose, meet user requirements, and produce accurate and reliable results. It also ensures that records can be retrieved and discerned from those that have been altered.
This is done using testing methods and documentation, including the V-Model. It also requires physical barriers to limit access to the hardware and software and a formal issue-reporting process.
What is the Measure of Accuracy?
The measure of accuracy is the degree to which a measurement process consistently produces results close to the actual value. This is called precision.
In the medical device industry, errors in computer systems that help patients and produce drugs or devices can have devastating consequences. They can also damage the brand of the MedTechcompany designing the system.
Computer system validation is a necessary and complicated process. It starts with a team of people with experience with regulatory guidelines/compliance, validation procedures, and laboratory processes.
What is the Measure of Reliability?
Every regulated pharma company should have a validation master plan. This will define each site and department’s projects, scopes, priorities, and requirements.
Any hardware used in computerized systems must be documented and undergo acceptance testing and installation qualification (IQ). Any bespoke hardware should also have its design verified.
The new CSA guidelines aim to refocus computer system validation activities away from compliance and quality assurance. The new approach is measured, sensible, and based on best practices rather than clause-by-clause adherence. It is designed to remove the stress and anxiety caused by an over-emphasis on compliance.
What is the Measure of Security?
Computer system validation (CSV) protects patients, ensures product safety, and prevents long-term brand damage for regulated pharmaceutical and medical device design and manufacturing companies. It’s also a way to ensure thorough auditing is completed for life science businesses’ digital tools to create their products and drugs.
FDA 21 CFR Part 11 regulations and GAMP 5 guidance require computerized systems to be validated and secure. This includes physically restricting access to critical hardware and software. It also includes limiting what can be done and how to accomplish it.
What is the Measure of Availability?
Understanding that service availability can mean more than 100% uptime is essential. Many companies analyze system availability weekly, monthly, or annually to discover trends in maintenance or other factors that could affect data reliability.
Regulatory agencies have tools that range from formal warning letters to product seizure and import restrictions. Avoiding CSVs is not an option for MedTech companies, as FDA investigators have long-term brand damage in mind. Completing a CSV efficiently and effectively is critical to staying compliant.
What is the Measure of Performance?
In the past, computer system validation (CSV) processes were often seen as a heavy burden for regulated companies. But today, it’s essential for ensuring quality and compliance.
The CSV process formally documents that software systems used in the highly regulated pharmaceutical and medical device industries do what they are designed to do. This provides an indelible electronic data trail to replace paper records and handwritten signatures.
For MedTech companies, it also helps prevent costly product recalls that impact patients and the brand. And, for the FDA ensures that a design or manufacturing process meets regulatory requirements.
