Validations

Validations

During our first meeting on a new project or customers request, Minnesota MedTec will ask if you need any type of validations or verification’s for the product.

  • Validation- Establishes documented evidence which provides assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. Consists of an equipment qualification and performance qualification. Equipment qualification focuses on the equipment rather than the processes or product itself. Performance qualification is that phase of validation which is directed at process and product attributes. These activities are generally performed in sequential order.
  • Equipment Qualification- A combination of an installation Qualification and an Operational Qualification:
    • Installation Qualification- Documentation that the installation of a piece of equipment conforms to specifications.
    • Operational Qualification- Documentation that the operating performance of a piece of equipment conforms to operating specification and establishes confidence the process equipment and ancillary systems are capable of consistently operating with established limits and tolerances. Performed in the absence of production materials or components.
  • Performance Qualification- A phase of validation which establishes that the process demonstrates effectiveness and reproducibility. In challenging a process to assess its adequacy, it is important that the challenge conditions simulate those that will be encountered during actual production, including “worse case” conditions. The challenges should be repeated sufficient times to assure that the results are meaningful and consistent.
  • Validation Protocol- A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points  on what constitutes acceptable test results.
  • Calibration- Demonstrating that a measuring device produces results within specified limits of those produced by a reference device over an appropriate range of measurements. The validation must demonstrate that all significant equipment are calibrated and operate properly during validation events.
  • Verification- Verification is performed during product/process development to ensure that the requirements or specifications are met. Verification does not prove consistency or capability. Verification is also used during equipment and software installations to verify that the proper connection or operation is functional.
  • Worst Case- A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, which pose the greatest chance of process or product failure when compared to ideal conditions. Such conditions do not necessarily induce product or process failure.
  • Most equipment will have IQ’s completed but new equipment will need to have the installation qualified to ensure that the equipment was installed properly.  After the installation, the equipment is performing up to its operational requirements.