GxP software, SoftMax® Pro

Supplier: Molecular Devices
MLDVSMP7XGXPSINGLEEA 0 EUR
MLDVSMP7XGXPSINGLE
GxP software, SoftMax® Pro
SoftMax® Pro 7.1.2 GxP Software is the latest, most secure software to achieve full FDA 21 CFR Part 11 compliance with streamlined workflows to ensure data integrity. Every step is optimized to simplify analysis and reporting to support Molecular Devices microplate readers.

  • The system audit trail tracks all changes including date and time stamps, username, user ID, section statements, signature information, and read results
  • The paperless document status system maintains data integrity with control over eSignatures and document workflows
  • User administration in a Windows Active Directory or via the GxP Admin software simplifies defining password criteria, reset and change periods, and reduces the amount of IT support
  • Users can only sign a single pre- and post-release statement per document contributing to data integrity
  • Permissions are defined on a per role basis and assigned accordingly to users within projects to maintain a structured system
  • Three predefined roles—Scientist, Lab Manager, Lab Technician—accommodate the document release workflow, allowing first-time users to get started quickly

The comprehensive suite of proven compliance solutions for GMP/GLP labs can advance efforts to quickly and confidently establish a compliant laboratory. An expert team will partner with users to set up single- or enterprise-level software, and provide IQ/OQ services using a validation package to establish full compliance on microplate readers.
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