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MasterControl Transfer Performance Qualification (TPQ)

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Data Sheet 1 Data Sheet MasterControl Transfer Performance Qualification (TPQ) Validation is often the costliest, most time-consuming aspect of installing or upgrading enterprise quality management software (EQMS) – representing a particularly significant challenge to small businesses. For customers of Spark™, MasterControl's cloud-based EQMS for small businesses, the industry-first Transfer Performance Qualification (TPQ) solution reduces the pains and costs of validation. Software Validation: FDA Expectations For companies regulated by the U.S. Food and Drug Administration (FDA), validation of electronic systems is required. The FDA does not mandate a specific validation methodology, but recommends that companies pursue the "least burdensome approach" regarding validation activities. Validation involves a series of tests, namely installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ). Especially for life sciences companies, software validation is a critical step in ensuring that software-automated operations will consistently produce results that meet predetermined specifications. For small businesses, which must meet the same rigorous regulatory requirements as large companies but with fewer resources, software validation can be especially burdensome. MasterControl TPQ for Spark: Advantages Having previously resolved the laborious tasks relating to IQ and OQ with the MasterControl Transfer OQ (TOQ) product, we've now also simplified the previously cumbersome PQ portion of the software validation process with MasterControl's Transfer PQ (TPQ) for Spark. Customers of Spark, MasterControl's hosted QMS specifically designed for companies with fewer than 50 employees, no longer have to bear the burden of these arduous tasks associated with PQ testing.

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