Computer System Validation As per GAMP 5

Good Automated Manufacturing Practice, or the GAMP 5, is a set of rules and guidelines that help ensure that medical devices and drugs meet quality standards. It describes a well-known standard for validating computer systems. The GAMP 5 is both a technical group of the International Society for Pharmaceutical Engineering and a set of rules for people who make and use computers or automatic systems. GAMP 5 was originally made for the pharmaceutical industry, but it is now also used as good advice for the medical device industry and other heavily controlled fields.

Quality must be put into every step of the manufacturing process, not just checked on a batch of products or devices. This is one of the main ideas behind GAMP.

So, our GAMP covers every part of production, from the raw materials, buildings, and tools to the staff's training and cleanliness. Standard operating procedures (SOPs) are important for steps that can change the quality of the final result. Our GAMP 5 also discusses Electronic Records and Electronic Signatures (ERES).

Why GAMP 5?

• It makes it easier to understand what regulations say.
• Sets up a shared language and set of terms.
• Encourages using a system life cycle method that is based on what works.
• Makes jobs and duties clear.
• Pay special attention to the computer systems that greatly affect patient safety, product quality, and data security.
• Only do the same things once.

Computer system validation requirements

You need a validation plan, training, paperwork, and standard operating procedures (SOPs) to validate a computer system. The requirements for computer system validation, specific controls, rule requirements, and their effects on dependability, availability, validity, and records are all covered by FDA guidelines, as outlined in FDA 21 CFR 11.

The FDA says that when computers or automatic data processing systems are used as part of the quality system or production, the company that makes the device must ensure that the software or its intended use is correct according to policy.

Good Automated Manufacturing Practice (GAMP) is a way to make sure that high-quality equipment is made. It is based on prospective validation for the life cycle, which the FDA and other government bodies use to ensure that computer systems are compliant and validated. Using a structured method to understand regulatory standards, the GAMP helps ensure compliance, speed, quality, and following the rules, which are all the better for CSV. To use GAMP 5 most efficiently and effectively, you should follow its guidelines for businesses and computer systems.

Good Industrial Practice for Active Pharmaceutical Ingredients (Q7) says the computer system should be verified. This depends on how complicated, varied, and important the computer system is. Computer gear and software should be able to do the job and show that they can do it by installing and operating correctly, which is necessary for the system to work properly. The computer system should be able to stop anyone from accessing or changing data without permission.