For FDA-regulated industries, especially life sciences companies, software system validation is a critical step in ensuring that software-automated operations will consistently produce results meeting predetermined specifications. Since the FDA requires computer systems to be in a constant state of validation, companies must make a substantial validation investment - both time and money - not just when they first install the software, but each time the application is upgraded, and re-validated. For most companies, software validation represents the single largest expense when automating or upgrading their quality management systems.
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MasterControl believes that validation is an integral part of software solutions for FDA-regulated customers. We provide a continuum of innovative validation products and services designed to allow "continuous validation" by making future upgrades easier, faster, and more cost-effective.
Computer software validation involves a series of tests, namely: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) tests. The FDA validation requirement allows each company to decide the level and intensity of testing depending on the organization's policy, risk assessment, and confidence level.
MasterControl Transfer OQ (TOQ) is a key part of MasterControl's continuous validation approach. Based on a company's corporate policy and risk assessment, it may choose to assimilate or "transfer" OQ documentation as part of its overall validation effort, saving both time and money. TOQ provides completed validation and support documentation of IQ/OQ tests performed at MasterControl. This documentation serves as evidence that basic functions of a MasterControl application perform correctly against a specification, both functional tests performed on individual components of the system and operational tests of the whole system.
MasterControl TOQ test scripts are available for MasterControl Portal, MasterControl Documents, MasterControl Process, MasterControl Training, MasterControl PDF Publishing, MasterControl PDM Connections, MasterControl Projects, MasterControl BOM, MasterControl Supplier, MasterControl Risk, MasterControl Audit, MasterControl Analytics, and MasterControl Submissions Gateway.