Validation Ready Documentation

Explore REMETREX PQMS validation documentation, IQ/OQ materials, architecture documentation, and the customer-controlled validation environment.

Team Discussion

Plant the Seed. Built for Growth.

Validation-ready documentation. A foundation for your qualification effort.

The strategic materials position documentation as part of the application foundation rather than something reconstructed after development.

REMETREX PQMS validation documentation, IQ/OQ materials, architecture documentation, and the customer-controlled validation environment.

The current materials describe IQ/OQ documentation and application documentation delivered with the license. The exact package should be confirmed during evaluation and reflected in the final statement of deliverables.

The development model emphasizes creating documentation alongside the application so that specifications, architecture, traceability, and system behavior have a clearer foundation.

The customer-controlled environment described in the strategic materials allows the organization to perform its qualification and validation activities in the environment it controls.

Maintain a structured investigation record tied to the complaint, including relevant product or device information, findings, related activities, and applicable linkages to other quality records.  Shared investigations such as Record Review (batch record reviews), retain samples and other types are entered once and link to cases for a product and lot.

Link lot together to provide consistency on trending to include lots that are related to the same bulk/semi-finished lot for more accurate trending.

Trending includes calculated upper control limits to flag lots that have surpassed the limit for the indicated category of quality defect.   This is used to identify recurring issues that surpass the calculated limit.   Once the UCL is surpassed additional investigations are needed.  But until it is surpassed, a lighter burden of investigation is needed saving valuable resources.

When the application is modified, the organization’s change-control process should determine impact assessment, testing, documentation, validation, and approval requirements.

Organize complaint information so Quality teams can evaluate patterns across products, complaint types, geographies, time periods, failure modes, and other relevant dimensions.

  • System understanding and qualification planning.
  • Requirements and traceability activities.
  • Installation and operational qualification activities.
  • Change-management documentation.
  • Future development and maintenance context.

Important Distinction

REMETREX PQMS can provide documentation and a validation-ready foundation; the customer remains responsible for its own validation and qualification decisions and activities.

Most quality leaders spend the first conversation trying to determine whether a new category is real or simply a pitch. Bring the hardest question. We will show you how the system and the model work.