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What Are Some Of The Consequences Of Faulty Computer System Validation?

The use of computers has become an integral part of pharmaceutical research and development. They are used in virtually all steps of the development process, and tend to increase the accuracy and speed of many development processes. However, it’s important to subject the computer systems to validation on a regular basis so as to ensure that the end product provides high quality. Faulty validation can result in numerous problems.

Poor manufacturing is a major consequence of faulty computer system validation. This is important in settings where the manufacturing is controlled primarily by computers. If they are not validated and verified on a regular basis, the risk of malfunction increases, and this in turn could result in batches of drugs that have chemical ratios that are wrong. This affects efficacy and toxicity of the drug.

Computer systems are also used for storage of critical information including the manufacturing protocols for the pharmaceuticals. In the case of a drug that has the potential to sell well, this information is valuable and should not get into the wrong hands. In this setting, validation ensures that the systems used to protect the data are ironclad to reduce the risk of theft.

Faulty computer system validation may result in negative reactions from people using the drugs as well as oversight bodies such as the FDA. These include not being allowed to distribute the drugs, lawsuits and boycotting of the drugs. This can happen if the faulty validation results in pharmaceuticals whose chemical compositions are not accurate.