Quality Management

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Quality Management System

The Quality Management module serves as a comprehensive tool for organizations seeking to enhance their quality management practices. With streamlined processes, centralized data management, and automated workflows, it facilitates compliance, improves efficiency, and enables data-driven decision-making to ensure the delivery of high-quality products and services.
  • Provides a complete system for quality assurance and documentation for pharmaceutical, biotech, dietary supplement, and CBD/hemp industries.
  • Makes accuracy and compliance more efficient with built-in workflows in an easy-to-understand, structured format.
  • Fully connects between the Electronic Batch Records, Inventory Management, and Document Management modules.
  • Ensures 21 CFR Part 11 compliance.

Deviations and Incident Management

  • Effectively tracks and manages deviations and incidents.
  • Records investigations and root causes.
  • Allows users to create and route deviations from any location.
  • Expedites investigations with multiple assignable action items, due dates, and email notifications.
  • Assigns investigations and monitors due dates.
  • Integrates with document management and electronic batch records.
  • Enforces GMP compliant workflows and procedures.
  • Automatically generates CAPAs with a single click.
  • Dispositions deviations and sends for review and approval.
  • Provides PDF printouts of each log record.

CAPA and Customer Complaints Handling:

  • Documents and monitors customer complaints tied to CAPAs.
  • Standardizes complaint handling.
  • Automates critical information capture with standard forms and email notifications.
  • Controls record-keeping for investigations and follow-up, reducing compliance exposure.
  • Integrates customer complaint handling with CAPA processes.
  • Records root causes of corrective and preventative actions.
  • Creates multiple corrective and preventative action items with due dates and assignments.
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Training Log and Learning Management System

  • Records training requirements and activities using a Training Log.
  • Integrates training functions with document management, equipment and batch records.
  • Captures full training data and monitors training status.
  • Attaches ad hoc documents to Training Records.
  • Easily duplicates training assignments for other users.
  • Triggers email alerts when training is required in a training log.
  • Enables single sign-on between InstantGMP and the Learning Management System.
  • Provides Wiki links connecting each application screen to related training information.
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Quality Management Module Features

  • Deviation Log

    Streamline deviation management and tracking processes to expedite investigations, root cause analysis, and reinforce GMP procedures.

  • CAPA Log

    Centralize CAPA-related actions creation, tracking, and assignment, while monitoring incidents and root cause investigations.

  • Compliant Log

    Proactively manage complaints with a built-in, standardized, controlled workflow, enabling users to capture vital information, track complaints from start to end.

  • Change Control Log

    Use pre-configured forms to collect and track information during the change process, and to automate reviewer and approver assignments based on predefined parameters

  • Vendor Management Log

    Collaborate with vendors and clients by editing and approving quality documents and contracts on-line.

  • Training Log

    Store and track personnel progress, and verify completion with digital signatures. Creating training groups for improved organization, with automatic email alerts for new materials or retraining.

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All InstantGMP Features

InstantGMP simplifies the documentation and approval procedures for quality processes. It provides inventory control, streamlines production, and elevates the overall quality of finished products while ensuring unwavering GMP compliance.

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