Product Information

Validation Services and Solutions - What Sets MasterControl Apart

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Data Sheet 1 Data Sheet What Sets MasterControl Validation Services and Solutions Apart For life science and other companies that must follow regulatory requirements, software validation can be a major burden in terms of time, cost and staffing resources. For most companies, it is the single largest expense associated with — and perhaps the most time-consuming aspect of — automating or upgrading their quality management and compliance systems. Why Validate? Validation of the processes and electronic system (if a company uses an electronic system) that generate data pertaining to product quality is critical to ensuring both data integrity and product safety. For companies regulated by U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), validation of their electronic systems is required. Outside of the FDA and EMA environments, validation is valuable because it reinforces the importance of product quality and safety. Companies in other regulated environments go through the validation process because they adhere to international guidelines and standards that will help them sell their products globally or increase the value of their products in the eyes of customers. What Is Validation? Validation is documenting that a process or system meets its pre-determined specification and quality attributes. To meet this requirement, a company must perform the following tests and provide documented evidence of the testing: • Installation Qualification (IQ), which confirms that the software was successfully installed according to specifications for correct and reliable functioning; • Operational Qualification (OQ), which involves the thorough verification and documentation that each function of the software operates as designed according to requirements and/or specifications; and

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