Easy

Build your custom validation protocols and reports in just a few simple to follow steps.

Flexible

Validation protocols and reports are able to be tailored toyour specific needs.

Reduce Quality Defects

Reduce waste, cost, and time to get a product to market.

Reduced Costs

No more expensive consultants, and lessen time to develop validations.

Installation Qualification (IQ)

Is establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturer’s approved specification and that the recommendations of the supplier of the equipment are suitably considered.

Protocol Form


Report Form

Operational Qualification (OQ)

Is establishing by objective evidence that all operating ranges within a process produce a result or product meeting its predetermined specifications. The extremes of the process allowed during normal production are challenged.

Protocol Form


Report Form

Performance Qualification (PQ)

Is establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. The Performance Qualification challenges a subprocess within the manufacturing.

Protocol Form


Report Form

Process Validation (PV)

Is establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications. The Process Validation challenges the production process from beginning to end.

Protocol Form


Report Form

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When to Perform Re-validation

November 3rd, 2020|

Previously, you have determined when validation is necessary in your organization and what validations to perform. For other details on this, please see previous posts: https://streamliningvalidation.com/2019/12/04/when-to-perform-which-validation/ https://streamliningvalidation.com/2019/08/05/sample-post-1/ As your organization moves into ongoing production and [...]