Software Validation

The goal of software validation is to ensure that your production and quality system software is validated according to a written procedure for the intended use, so that it performs as intended and fulfils its purposes.

Adequate software validation consists of a range of aspects, from planning, system verification and validation to testing, traceability and configuration management. This applies to both validation of product or device software and validation of software used to design, develop or manufacture devices and products.

When using computers or other systems for automated data processing in the pharmaceutical sector, it is important to validate software. However, modern software might present a significant challenge to control. To guarantee safety and reliability, software must meet specific regulations and guidelines. The QbD software validation experts are experienced in validating pharmaceutical computer systems and pharmaceutical software, including:

  • Manufacturing Execution Systems (MES)
  • Laboratory Information Management Systems (LIMS)
  • Electronic Batch Record Systems (EBR)
  • Manufacturing Resource Planning Systems (MRP)
  • Lab system software (HPLC, FTIR, GC, etc.)

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