Computer System Validation (CSV) holds a significance that goes beyond merely safeguarding profits and mitigating business risks. In certain situations, it transcends into a life-saving practice.
Consider the scenario of medication defects detection. The ability to identify such defects through CSV can prevent potentially harmful side effects and avert the substantial harm that a consumer of a faulty drug might have otherwise endured.
This underscores why CSV is not just an optional process; it's mandatory in specific industries. Below is a list of businesses that are legally obligated to conduct Computer System Validation:
1. **Pharmaceutical Companies:** In the United States and most developed countries, pharmaceutical businesses are mandated to undergo CSV. Particularly, if a business is involved in the production or distribution of drugs used for diagnosing or treating diseases, system validation becomes imperative.
2. **Storage and Distribution Providers:** Enterprises engaged in the storage of pharmaceuticals, biologicals, or cell-and-tissue products are bound by regulations to complete CSV. Failure to adhere to these requirements might lead to severe penalties, including debarment or even criminal prosecution.
3. **Biologicals Manufacturers:** Products classified as biologicals are also subject to CSV requirements. A product is considered biological if it's derived from a therapeutic serum or virus and is intended for the prevention and treatment of injuries or diseases. This encompasses items like vaccines.
4. **Medical Device Distributors:** Medical devices, which encompass instruments used for diagnosis, treatment, or prevention of illnesses, are subject to CSV regulations. Examples include lasers, medical implants, thermometers (medical-grade only), tongue depressors, and prosthetics.
In these industries, where precision, safety, and compliance are paramount, CSV becomes a critical stage in ensuring the reliability and effectiveness of systems. Beyond economic considerations, the implementation of CSV holds the potential to protect human lives by ensuring the accuracy and safety of medical treatments, drugs, and devices.