ReSol Systems - QCSFusion CAPA

QCSFusion CAPA (Corrective and Preventive Action)

QCSFusion’s CAPA module allows a user to reject or approve CAPAs, view corrective action status, designate responsibilities to users, detect trends and effectiveness and attach or link files. The system will send email alerts notifying members of the workflow status throughout the process.

 

QCSFusion can be easily customized to configure the workflow according to your organization’s processes and SOPs. The customized fields offer a variety of data formats to ensure an easy search within the system.

 

Being GMP and CFR Part 11 compliant, the QCSFusion CAPA module provides a complete solution that makes the review and approval process simple and efficient.  QCSFusion controls the roles of authors, reviewers and approvers by ensuring that the records are complete and accurate.  QCSFusion ensures timely completion and approval of CAPAs.

ReSol Systems - Features

Features

  • Interactive form attachments permit you to fill out corrective/preventive actions as the route is processed, with field locking and part 11 compliant signatures

  • 21 CFR part 11 compliant

  • E-signatures

  • Communication via e-mail (alerts / reminders)

  • Multi-level file structure so that documents can be organized effectively

  • Flexible workflow that is configurable according to your already established business processes and procedures

  • Detailed audit trail include

    •    System-stamped date and time

    •    User who performs the activity

    •    Information of action performed

    •    Reason for changes

  • Flexible roles / responsibilities that can be assigned based on customer needs

  • Searchable

  • Audit Trail

  • Option to stamp CAPAs for printing

  • Capability to control variety of CAPA types

  • Editable templates (default and / or user created)

  • Ability to email a copy of CAPA to any party (auditors, customers, suppliers, etc.)

  • View status of all corrective/preventive actions in your system

  • Review and Approval workflow

  • Cross-references to link related documents

  • Attach unlimited files to any corrective/preventive action

  • Task list for users to view tasks assigned to them

  • Assign time requirements for certain workflows and issue alerts / reminders to assure timely completion and enforcement