EVOM™ GxP Compliance Module Powered by TotalLab

EVA-GXP-01-01

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Prices valid in USA, Canada, and PR only.

EVOM™ GxP compliance Module is 21 CFR Part 11 compliant software that meets the FDA's requirements for electronic records and signatures.

EVOM™ GxP Compliance Module include:

  • Audit Trails: EVOM™ GxP Compliance Module generates a date- and time-stamped audit trail of changes to projects. Audit trails are made available in PDF format for read-only inspection.

  • Security:

    • Access to the system, and therefore the records stored within, is limited to authorized users by username and password credentials. In addition, users must be granted authority to perform certain actions, such as sign-off.

    • EVOM™ GxP Compliance Module automatically generates time-stamped records showing user actions and maintaining the project-related data at each timestamp. The user who took the action is also recorded.

  • Electronic Signature: EVOM™ GxP Compliance Module restricts access to records through the use of username/password credentials and only certain users have the privileges required to sign-off/approve work. Signatures affixed to records within the GxP system are permanently attached within the system and are not accessible by any user for the purposes of deletion, alteration or transfer.

  • Archiving: EVOM™ GxP Compliance Module maintains versions of projects on the server. These snapshots are accessible by server administrators for backup to another storage system, if required.

Details

Unsure how GxP affects your lab work?

Get the facts on the GxP Compliance page!

Why Choose the EVOM™ Auto Compliance Module Add-On

The EVOM™ Auto GxP Compliance Module is a powerful solution designed to help GMP/GLP laboratories achieve FDA 21 CFR Part 11 compliance with secure, traceable, and audit-ready electronic records when using our EVOM Auto 96 or 24 system. By integrating advanced security controls, this module ensures data integrity, authenticity, and system access protection, helping labs meet regulatory requirements with confidence.

Key compliance features include user-configurable password strength controls and timed password expiry, limiting system access to authorized individuals (21 CFR 11.10(d), 21 CFR 11.200(a)). User privileges are fully configurable, ensuring that only approved individuals can sign off on electronic records, preserving data authenticity and traceability (21 CFR 11, Subpart B). A built-in emergency access protocol prevents workflow disruptions by allowing authorized recovery of locked-out accounts (21 CFR 11.200(3)). Additionally, seamless integration with Windows Active Directory logins and passwords enforces controlled access management (21 CFR 11.10(d)).

The EVOM™ Auto GxP Compliance Module enhances security by detecting and recording unauthorized access attempts, ensuring that only users with valid credentials can access the system. With operational and authority checks, specific actions or sequences can be automatically disabled to maintain system integrity. For audit and security purposes, every electronic signature is permanently associated with its corresponding record, including the date, time, and reason for approval, providing full transparency and traceability.

By implementing the EVOM™ Auto GxP Compliance Module, labs can simplify compliance, strengthen data security, and confidently meet regulatory expectations while maintaining operational efficiency.

Resources

Video

AuditSafe 21 CFR Part 11/GMP-Compliance Software Client Guide

 

 

How to Configure AuditSafe 21 CFR/GMP-compliant Software

 

 

21 CFR Part 11 Compliance: User Management in AuditSafe Software

 

 

How to Make Microsoft Excel 21 CFR Compliant Using AuditSafe

 

Specifications

This unit conforms to the following specifications:

Type Description
Autosampler Dimensions (W×D×H) 16×10×8.4”
Autosampler Weight 15.5 lbs.
Interface Unit Weight 1 lb.
CE Certified Yes
UL/CSA Certified Yes
Compatibility 96-well HTS Plates (Corning, Millipore, MatTek)
24-well HTS Plates (Corning, Millipore)
Resistance Range 10KΩ, 50KΩ, 100KΩ
Number of Rinse Stations 3
Electrode Array for 96 HTS Plate Array of 8 pair of (1.2mm Φ) electrodes
Electrode Array for 24 HTS Plate Array of 4 pair of (1.2 mm Φ) electrodes
Minimum Sample Reading Time 1 Second
Device Connectivity Wi-Fi
Wi-Fi Range 25 ft./7 m
Software Type Web browser
Control Device for Running Software Laptop running EVOM™ GxP Client
Output Data CSV/Microsoft® Excel
Equipment rating 12 VDC 1.67 A
Operating Temperature Range (Autosampler) 15°C (59ºF) to 40°C (104°F)
Humidity Rating (Autosampler) 10% to 98% RH, non-condensing
Operating Temperature Range (Interface Unit) 15°C (59ºF) to 35°C (95°F)
Humidity Rating (Interface Unit) 10% to 90% RH, non-condensing
Maximum Altitude: Standard Commercial Electronics Up to 2000 m (6562’)
IPX rating IPX0; No protection against water
Pollution Degree 1  
  • Definition
 No pollution or only dry, non-conductive pollution occurs
  • Typical Environment
 Clean rooms, laboratories, and other controlled environments where dust and moisture are minimal
  • Impact on Insulation
 Pollution does not affect the insulation of the equipment
Specification for intermittent operation limits (duty cycle if applicable) No minimum. The equipment can operate continuously (100% duty cycle).

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