Validation & Qualification Management

Description

The Validation & Qualification Management form allows users to document, track, and manage validation and qualification activities critical to ensuring equipment, processes, and systems meet regulatory and operational requirements. It provides a structured workflow for defining, reviewing, and approving validation protocols, ensuring comprehensive documentation and compliance. Users can initiate new validation studies, update qualification records, track approval statuses, and maintain historical data for regulatory and operational traceability. This structured approach enhances process control, supports data integrity, and ensures alignment with industry standards and regulatory expectations.

Access the Validation & Qualification Management:

• Step #1: Move your cursor to the "MODULE" tab located in the top-left corner of the screen.

• Step #2: In the drop-down menu that appears, hover over "Validation Management". This will expand a new menu displaying the following modules:

  • Experimental Projects

  • Media Fills

  • Validation & Qualification

• Step #3: Pass your cursor over "Validation & Qualification". Another drop-down menu will appear, showing the forms available within this module.

• Step #4: Select the "Validation & Qualification Management" option from the drop-down menu to access the main dashboard for this module.

Guide to Access Validation & Qualification Management

Notes: Only active users with a license, access rights, and privileges for this form can access the information. If you do not have access to a specific form or its functionalities, contact your company’s system owner or administrator to request the necessary access and privileges.