ReSol Systems - QCSFusion Complaint Management

QCSFusion Complaint Management

An effective Product Complaint Management system is a critical component in the pharmaceutical industry from compliance, regulatory and business perspectives. Prompt action following costumer complaints is critical. Therefore, managing product complaints from initiation through resolution is a necessity.


An effective complaint management software system is essential in supporting the following goals: customer retention, customer safety, compliance with industry regulations, and avoidance of potential product liability lawsuits.


The QCSFusion Complaint Management module provides the ability to record, investigate and respond to complaints, in addition to monitoring trends. This automated process will considerably improve your company's quality performance.

Features

  • Document Repository for all documents types - internal and external

  • GMP and 21 CFR part 11 compliant

  • E-signatures

  • Communication via e-mail (alerts / reminders)

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

  • Secure documents so that only authorized personnel can move, edit, archive

  • Detailed audit trails 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

  • Review and Approval workflow

  • Cross-references to link related documents

  • Task list so users can see what tasks are assigned to them

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

  • Searchable

  • Revision history

  • Option to stamp documents for printing

  • Capability to control variety of document types:

    •    SOPs, policies, work instructions

    •    Forms

    •    Batch records

    •    Certificates of Analysis (C of As)

    •    Regulatory submissions

    •    Regulatory correspondence

    •    Deviations / Investigations - CAPA

    •    Documentation related to change control

    •    Validation documentation

    •    Manuals, instructions

    •    Employee training and qualification records

    •    Project documentation

    •    Investigation documents, photographs, etc.

    •    Audit reports and follow-ups

  • Change control process

  • Editable templates (default and / or user created)

2010 - present

2010 - present