QCSFusion Deviation Module

Deviations can arise during various stages, including manufacturing, analytical testing, and product distribution. In FDA and ISO regulated environments, any deviation from documented procedures and specifications necessitates thorough documentation, investigation, justification, and approval by the Quality unit. QCSFusion equips users with effective tools for documenting, resolving, and approving deviation records. Transitioning from a paper-based system to an automated one enhances management efficiency and provides better control over deviations. By seamlessly integrating with other QCSFusion modules, the deviation module ensures an efficient process, promoting quality and compliance while minimizing the risk of human error.

Thanks to the highly customizable nature of the QCSFusion system, it can be tailored to meet your organization's unique compliance requirements and processes. The workflow is adjustable according to your organization’s specific processes and SOPs. Customized fields support various data formats, facilitating easy searches within the system.

GMP and 21 CFR Part 11 compliant, the QCSFusion CAPA module delivers a comprehensive solution, streamlining the review and approval process with simplicity and efficiency. The QCSFusion system regulates the roles of authors, reviewers, and approvers, ensuring the completeness and accuracy of records.

Ensuring timely completion and approval of deviation records, the QCSFusion system sends email alerts and reminders to responsible parties. Given the critical importance of timely deviation record completion for product release and shipment, adopting the QCSFusion system proves to be a cost-effective solution for your company.


  • 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 document for printing
  • Capability to control variety of Deviations types
  • Editable templates (default and / or user created)
  • Ability to email a copy of Deviations 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