winspc regulatory software validation

Software Validation

Software Validation

Conquer your compliance requirements

Let us assist you in performing a WinSPC or QualTrend software validation by preparing the documentation and performing the necessary steps that confirm your implementation correctly meets the specifications of your organization and the regulatory requirements of your industry. DataNet offers expertise to assist you in moving through the validation process accurately and cost-effectively.

  • Installation Qualification (IQ) and Operational Qualification (OQ): Our Installation and Operational Qualification services enable your organization to deploy WinSPC in compliance with industry regulatory requirements. The IQ consists of test cases to ensure that WinSPC components are properly installed according to DataNet’s Installation and Configuration Guide. The Operational Qualification (OQ) consists of test cases to ensure that key components of WinSPC are properly operating according to DataNet specifications and are in compliance with provisions of FDA 21 CFR Part 11 or other regulatory standards. Our Software Validation expert travels on-site to perform the tests and produce the necessary documentation required by your organization.
  • Performance Qualification (PQ): Let our experienced validation team assist you in performing a WinSPC Performance Qualification at your location. Our validation expert will validate the operation of WinSPC to ensure that the system performs as intended for use in your production operations. Services include developing, documenting and validating your unique performance test cases to assure your system meets regulation requirements, then performing the tests to verify the system performs as intended.
  • WinSPC Software Validation Tool Kit (do-it-yourself templates): Our Software Validation tool-kit offers a series of templates and test cases necessary to perform a do-it-yourself Installation and Operational Qualification of WinSPC.

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