Nonconformance – NCR

REMETREX® NCR is a web-based, enterprise level nonconformance management system designed for seamless data integration and linking with our REMETREX® CAPA solution. Through its comprehensive workflow management and flexible functional capabilities, REMETREX® NCR enables you to improve your quality process and achieve sustained regulatory compliance.

NCR Features

• Design consists of multiple layers of access control and multi-location
  NCR numbering schemes
• 21 CFR Part 11 and 21 CFR Part 820.100 compliant
• Designed to process issues from open to close and provide complete documentation for trending and reporting
• NCRs are tracked from general to detailed descriptions, utilizing a three-level category scheme with root cause identification
• Provides multiple methods of communication, including assigning file responsibilities and progress monitoring
• Email notifications can be generated by NCR requirements, workflow assignments or custom data driven events
• Designed for customization to an individual company's requirements, such as product and non-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 the NCR. These files are securely stored in the system database and may be downloaded by system users. Attachments are complete with audit trail
• Automated review and approval processes

NCR Reporting Module

• Generate reports based on a variety of NCR 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 further parameter 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

Stericycle Process