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Overview


Complaint Handling Software – PQ

REMETREX™ PQ is a web-based, enterprise level complaint handling system designed to increase your productivity while enabling you to achieve continuous improvement, enhance quality and meet regulatory compliance.

PQ Features

  • Design consists of multiple layers of access control and multi-location complaint numbering schemes
  • 21 CFR Part 11 and 21 CFR Part 820.100 compliant
  • Designed to process complaints from open to close and provide complete documentation for medical device and pharmaceutical reporting
  • Complaints are tracked from general to detailed descriptions, utilizing a three-level category scheme
  • Provides multiple methods of communication, including assigning file responsibilities and progress monitoring
  • Email notifications can be generated by complaint requirements, workflow assignments or custom data driven events
  • Designed for customization to an individual company's requirements, such as contact demographic information, product specific information, reports and additional options required by each company
  • Provides ability for managing corrective actions, batch record reviews and product analysis
  • Provides ability for attaching and modifying photos, documents, Emails, PDFs etc. to complaints. These files are securely stored in the system database and may be downloaded by system users. Attachments are complete with audit trail

    PQ Reporting Module

  • Generate reports based on a variety of complaint file information
  • User defined report parameters can be saved and reused, saving time and providing reporting consistency
  • Reports can be generated in PDF, Excel and other popular formats
  • Reports can be run in real time, or submitted to batch and Emailed back to you upon completion
  • You can also schedule your reports once and have them run daily, weekly, monthly etc. and receive them via Email
  • Report titles are customizable and can be saved with report parameters
  • Selection criteria chosen can be appended to the report, to provide furtherparameter clarification
  • Adhoc reporting component allows you to select the data you want, in the sequence you want with the criteria you want, all within an
    easy and intuitive interface
Complaint Software – PQ
CAPA Software – CAPA
Non-Conformance – NCR
Technical Overview
Training
NNC Process

 

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Copyright © 2002 - 2004 REMETREX Incorporated
Pharmaceutical and Medical Device Quality Systems and Solutions For Complaint Handling, Corrective and
Preventive Action (CAPA) Management
and Non-Conformance (NCR) Management / FDA 21 CFR Part 11 Compliant