Automate change across your company.
Stratas QM lets you manage change across every department. Keep track of progress from the initial request, through pre-approvals, change execution, follow-up approvals, and implementation.
Easily handle every type of change request, including: batch, documentation, EH&S, equipment, hardware/network, materials, packaging/labels, process, regulations, specifications, supplier, and validation.
Improve visibility and collaboration.
Eliminate any potential miscommunication among departments. All users can see what changes have been requested, their status, and who is responsible for completing the workflow.
Comply with regulatory agencies.
The system supports FDA compliance requirements for manufacturing quality production and several other regulatory standards and industry best practices.
A secure and compliant platform.
The Stratas application and environment are 21 CFR Part 11, GxP, EU-U.S. Privacy Shield, and SOC II