Computer System Validation has been a regulatory (e.g. FDA, Health Canada) requirement for more than two decades. Nevertheless, companies have problems with its understanding, scope, implementation and maintenance. This is proven through many FDA warning letters related to device software and computer system validation. IT professionals know the principles but have problems with its implementation, especially with the development of protocols (IQ, OQ, DQ, PQ) to satisfy the U.S. Food & Drug Administration and other major regulatory agencies around the globe.

In the United States, general regulations for drugs, food and cosmetics, are set down in Title 21 Code of Federal Regulations for Food and Drugs, and relate to the expanded Federal Food and Cosmetic Act. 21 CFR 210/211 that describes the “current Good Manufacturing Practice” (cGMP) for human drugs. To ensure these stringent requirements are met for critical equipment used in manufacturing, medical devices and to some degree quality management systems, validation activities for automatic, mechanical and electronic equipment must be assured prior to commercialization of drug products.

Software or IT companies that are implementing a new system such as ERP for life sciences companies, need to validate the system before going live. The validation is performed by regulatory experts to ensure the processes are in compliance. What is often overlooked by IT professionals is the validation costs that could go up as much as implementation costs. Companies can save on costs by implementing already validated software solutions or choosing implementation partners with expertise in life sciences regulatory and quality requirements.

Use this handy criteria to determine if your system or software requires validation:

• Operations in GxP (Manufacturing, Laboratory, Clinical, Distribution) practices
• Used as a medical device or component of a medical device group/kit/instrument
• 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
• Used in traceability and inventory control of health product (raw materials/components and finished products)
• Used in recording health product manufacturing and control batch history information (electronic Batch Record) including e-signature
• Used in collecting & archiving clinical data to order to make medical interpretation/assessment for treatment
• Used in Environmental Control provisions of health product process e.g. HVAC
• Used in critical supply of utilities in health products manufacturing
• Used in Laboratory to inspect and test health products
• Used in data records (word processing, spreadsheets, databases) to ensure integrity
• Wireless technology or interface employed for above functions