ReSol Systems - QCSFusion Deviations

QCSFusion Deviations

Deviations may occur during manufacturing, analytical testing, product distribution etc. In FDA and ISO regulated environments, a deviation from written procedures and specifications must be documented, investigated or justified, as well as approved by the Quality unit. QCSFusion provides customers with the tools to effectively document, resolve and approve deviation records. Substituting a paper-based environment with an automated system allows for more efficient management and better control of deviations.  By integrating with other QCSFusion modules, the deviation module guarantees an effective process to accomplish quality and compliance while decreasing the potential for human error.

 

Since the QCSFusion system is highly customizable, it can be modified to meet your organization’s unique compliance requirements and processes. The workflow can be configured 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 21 CFR Part 11 compliant, the QCSFusion CAPA module provides a complete solution that makes the review and approval process simple and efficient. The QCSFusion system controls the roles of authors, reviewers and approvers by ensuring that the records are complete and accurate.

 

The QCSFusion system ensures a timely completion and approval of a deviation record.  Email alerts and reminders are sent to responsible parties. Since a timely completion of a deviation record is crucial for the release and shipment of the product, using the QCSFusion system will be cost effective for your company.

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

2010 - present

2010 - present