Corrective and Preventive Action - CAPA

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

CAPA Features

• Designed to process issues from initiation to final signoffs
• Issues are tracked from general to detailed descriptions, utilizing a three-level category scheme
• Design consists of multiple layers of access control, personalized menu views and multi-location data filters
• 21 CFR Part 11 and 21 CFR Part 820.100 compliant
• Provides complete audit trail & activity history
• Provides multiple methods of communication, including assigning file responsibilities and progress monitoring
• Configure your own CAPA requirements and workflow assignments based on CAPA type and characteristics
• Email notifications can be generated by workflow assignments or custom data driven events
• Provides ability for attaching and modifying photos, documents, Emails, PDFs etc. to issues. These files are securely stored in the system database and may be downloaded by system users. Attachments are complete with audit trail

  CAPA Auditing Module

• Enables users to dynamically create proactive task initiators such as periodic internal quality audits
• System will automatically generate action item requirements and workflow assignments
• Email notifications are generated to the appropriate personnel
• Users have the ability to perform, record and track results of their investigation and any follow-up actions necessary

CAPA Reporting Module

• Generate reports based on a variety of 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
  

NNC Process