Product Quality Review (RC-PQR)

Product Quality Review System (RC-PQR)

Objective of the Product Quality Review System (RC-PQR)

Each manufactured product requires a product quality review. It is essential to prepare, document, conduct and evaluate all your product quality reviews in an effective way.

The Rescop Product Quality Review System automates, controls and supports the Product Quality Review process, in accordance with GxP regulations.

Main functionalities of the Product Quality Review System (RC-PQR)

  • Manage the PQR template
  • Create PQR documents based on the template
  • Generate content of PQR documents automatically, incl.:
    retrieving data automatically from source systems, like: LIMS, ERP, MES, etc.
    performing data conversion, processing and trending automatically
  • Create and manage content of PQR documents which cannot be generated automatically, e.g. clarifications and conclusions
  • Automated workflow for review and approval of PQR documents, incl. electronic signatures
  • Monitor status and progress of PQR documents
  • Automated alerts for (nearing) overdues, incl. escalation
  • Management Reporting

Benefits of the Product Quality Review System (RC-PQR)

You are able to maintain permanent inspection readiness through a consistent and compliant execution of the PQR process through standardization of approach, documentation and content with automated alerts, including escalation. You will have a centrally and readily retrievable PQR documentation and status overview with Management Reporting.

An efficient PQR process is enabled by automated generation of content, including retrieval of source data, data processing, conversion and trending. The Rescop Product Quality Review System contains an automated workflow for review and approval. Also it has a central point for storing, managing and sharing PQR documentation and knowledge.

Maintain paperless compliance and be 21 CFR part 11 and Eudralex Annex 11 ready with the Product Quality Review System of Rescop.

Product Quality Review System

Product Quality Review System

Product Quality Review System

Product Quality Review System workflow

More information?

Request a free demonstration of the Rescop Product Quality Review System

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