![]() ![]() In certain instances, it can be life-saving.įor instance, detecting medication defects can prevent unfortunate side effects and avoid significant damage a drug consumer would’ve otherwise received. Who Needs Computer System Validation?Ĭomputer System Validation is more than a way to avoid profit loss and business risks. The range of activities heavily depends on the company’s profile, scale, and the market where it operates. This is not a definite list of operations that fall under the term of Computer System Validation. Maintaining system release documentation.Writing Operational Qualification (OQ) Scripts.The list of CSV activities usually consists of: ![]() In software, CSV is perceived as a method that allows business managers to successfully complete the tasks a system was designed for, have control over user operations and their security, and be legally compliant. For starters, business managers need to broaden the scope of the term beyond a PC and the software suite installed on the device.Ĭomputer systems include all the complementary equipment that supports the system as well as its users as a whole. Before getting into the meaning of CSV, it’s crucial to understand how the Food & Drug Administration (FDA) and other regulatory bodies define computer systems.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |