Build your custom validation protocols and reports in just a few simple to follow steps.
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.
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.
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.
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.
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.
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 [...]
Companies are constantly looking for ways to increase their bottom lines and increase their profits. Many companies are public or owned by another company which means they are responsible to their stockholders and parent companies. [...]