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If you have any questions about our software validation process, please contact us.

The Validated Training Program was established to validate the training programs offered in our industry.

If this was the only capability analysis available in Minitab, then the software would not be validated for non-normal capability analysis.

Fortunately, Minitab Nonnormal is chosen and an appropriate distribution is selected (Weibull in this case), the Ppk (0.69) and defect rate (8993 defects per million) are found to be poor, as shown in the following graph: Software packages that are used to monitor the process and determine the quality level, such as Minitab, should be validated.

For example: A) Your firm uses off-the-shelf software (***** Help Desk) to manage customer support service calls and to maintain customer site configuration information; however, your firm failed to adequately validate this software in order to ensure that it will perform as intended in its chosen application.

Specifically, your firm's validation did not ensure that the details screen was functioning properly as intended.

Go back to basics and participate in the HACCP Mentor Food Safety HACCP Challenge.

This initiative is a great way to verify basic compliance activities within your food business whilst learning as you go.

Below is a section from a warning letter that refers to the failed validation of an off-the-shelf helpdesk software product, and a document management tool.

The intent of the program is to develop training resources for installers that will ultimately benefit specifiers, contractors, manufacturers, and end-users of sealant, waterproofing and restoration specialties.

It is felt that specifiers, contractors, manufacturers and other end-users will feel more comfortable in using installers that have completed installation training as outlined in SWR Institute’s Validated Training Program.

However, your firm has failed to adequately validate this software to ensure that it meets your needs and intended uses.

Specifically, at the time of this inspection there were two different versions of your CAPA & Customer Complaint procedure, SOP-200-104; however, no revision history was provided on the “Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system, as required by 21 CFR 820.70(i).“ … §820.70(i) (Production and Process Controls – Automated Processes).” …

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