Computer system validation

A computerized system can include hardware, software, its peripherals, interfaces, equipment, users, and operating procedures. Today, in the health products industry that encompasses pharmaceuticals, biologics, vaccines, biotechnology, natural health products, medical devices, cosmetics and allied industries, software and hardware components are used for the purposes of data processing, data storage, and process control.

Computer system validation is essential for competent risk management and it improves product reliability, increases patient safety, and ensures the systems are running accurately within regulatory requirements. 

According to US FDA, “Computer system validation is the process of providing a high degree of assurance through documented evidence that a computer system consistently meets its pre-determined or intended use or quality attributes such as accuracy, security, reliability, and functionality.”

Under FDA software validation requirements for medical devices, “any software used to automate any part of the device production process or any part of the quality system must be validated for its intended use,” as required by 21 CFR §820.70(i). This requirement applies to any software used to automate device design, testing, component acceptance, manufacturing, labeling, packaging, distribution, complaint handling, or to automate any other aspect of the quality system

Computer system validation provides documented evidence that software/hardware applications meet their intended uses by testing regulated functional processes as well as requirements related to electronic records and electronic signatures.

In the pharmaceutical industry in general, this process is of high importance when it comes to various machines that are involved in the production of medicinal products: you really want those 500 mg tablets to be 500 mg tablets. 

Other aspects include medical devices that are used to deliver drugs to patients: again, you would really like that insulin pump to work as advertised and deliver your insulin at the exact time and dose you have specified. This is what usually comes to mind when we talk about CSV, and most of the guidelines and requirements are covered by Good Automated Manufacturing Practice (GAMP) and Good Manufacturing Practice (GMP).

Sample checklist of areas requiring software validation include:

1. Automated operation and/or control in “GxP” (Manufacturing, Laboratory, Clinical, Distribution) environments 
2. Software used as a medical device or as a component of a medical device; 
3. Controlling of health product (medical device, pharmaceutical, natural health product, biologics in humans or animals) manufacturing or control process, e.g., weighing, mixing, compounding, labeling, automated inspection systems, laboratory information system 
4. Used in traceability and inventory control of health product (raw materials, components, bulk, finished products, devices) 
5. Used in recording health product manufacturing and control batch history information (electronic Batch Record) including e-Signature 
6. Used in collecting & archiving clinical data to order to perform a medical assessment of risk & treatment 
7. Used in Environmental Control provisions of health product process, e.g., HVAC 
8. Used in critical supply of utilities in health products manufacturing, e.g., CIP/SIP, Purified Water 
9. Used in Laboratory to inspect and test health products 
10. Used in data records (word processing, spreadsheets, databases) to ensure integrity 
11. Wireless technology or interface employed for any of the above functions