Let us assist you in performing a Win SPC or Qual Trend software validation by preparing the documentation and performing the necessary steps to assure your system and operation correctly meets the specifications of your organization and the regulatory requirements of your industry.Data Net offers expertise to assist you in moving through the validation process accurately and cost-effectively.Each tool appearing in bold is further described in Section 4.One tool that is particularly useful in organizing the overall validation effort is a failure modes and effects analysis (FMEA) or a closely related fault tree analysis (FTA).
You will encounter (or have encountered) all kinds of usage and interpretations of those terms, and it is our humble attempt here to distinguish between them as clearly as possible.
Control charts, capability studies, designed experiments, tolerance analysis, robust design methods, failure modes and effects analysis, sampling plans, and mistake proofing are but a few.
Each of these tools will be summarized and their application in validation described.
Validation Plans are different than Validation Master Plans.
Validation Plans are usually project specific; Validation Master Plans govern validation activities for an entire organization or site.