CSV (Computer System Validation) compliance is something that the FDA and the European Regulatory Authorities take very seriously. Software programs that are not in compliance with validation and the associated infrastructure qualification measures could result in a product recall by the government.
Regardless of whether a software program is developed by a company itself or is purchased off-the-shelf, it should have a defined objective before it is used for a specific purpose.
Validate All Programs
Following the publication of the FDA’s “General Principles of Software Validation” firstly in 1997, and a revised edition in 2002, computerized systems use in the manufacture of medicines and medical products were regarded as legacy and new systems. All legacy systems and systems after the publication of the FDA’s guidance must be validated. Furthermore, the underlying infrastructure of the software application has to be qualified.
While this can be a complex process to go through, properly validating software avoids FDA warning letters and other potential government actions such as the issuance of a 483. Consultants can assist you to attain compliance in accordance with the laws and guidelines put in place by the FDA to ensure that all software and hardware used throughout the lifecycle of any pharmaceuticals and/or medical devices will do exactly what it is intended to do.
Human Error Can Lead to Software Issues
Modern software development is a process in which a team of developers cooperate to produce the finished product. This software is usually complex and can give rise to the occurrence of bugs and other errors in the software. It is therefore necessary to either completely eliminate these errors prior to the use of the software in a GMP environment, where they could cause irreparable damage.
If a product is found to be defective, it can be recalled immediately, and the product could be taken off the market permanently. That could result in thousands or even millions of dollars in wasted money to develop a product. Therefore, it is clear that proper oversight on any project is crucial.
Software Flaws Are Common
The FDA estimates that software programs that are not validated correctly prior to use comprise 79% of all product recalls. This fact indicates that pharmaceutical and medical device companies require correctly planned and documented testing to be in place prior to releasing any software or product, which involves the use of software involved in its manufacture. If you are having difficulty achieving compliance, or bringing your product to market, GxP-CC is able to provide the appropriate compliance experts to help create and oversee a testing process that will result in fewer errors and eliminate product recall.
Failure to validate a computer system could result in negative consequences for your company as well as your pharmaceutical product / medical device itself. Computer programs that do not perform effectively may result in a faulty product, which may have dire consequences for the end user of the product. It is essential you have someone to turn to who understands CSV regulations inside and out.
GxP-CC is a leading compliance consultant company in the pharmaceutical, medical devices and dental lab industries. Contact them today to discuss your CSV issues.