Overview
Data integrity is vital in drug development, which relies on accurate, complete, and consistent data to determine the correct formulation, dosage, and safety profile of a drug.
Regulatory frameworks such as 21 CFR Part 11, Annex 11, and USP <1058> have been established to ensure data integrity through secure electronic records, electronic signatures, and qualified analytical instruments. While 21 CFR Part 11 and Annex 11 focus on the management and protection of electronic data, USP <1058> provides a structured approach to Analytical Instrument Qualification (AIQ), ensuring instruments consistently deliver reliable and reproducible results. Audits to ensure regulatory compliance are often laborious and time-consuming, yet highly critical.
OmniTrust is designed to support our customers in achieving regulatory compliance and make auditing processes more efficient. This is achieved by including both software and service components to support you.
What’s really good about this OmniTrust system is that it just does everything… it’s really about the user friendliness.”
![[Omnitrust graphic v2.jpg] Omnitrust graphic v2.jpg](https://dam.malvernpanalytical.com/4b33f3dc-e7ef-4a20-93bb-b36b00e4109a/Omnitrust%20graphic%20v2_Original%20file.jpg)
OmniTrust software streamlines workflows and reduces the administrative burden for data integrity associated with compliance for your Malvern Panalytical portfolio.
Developed to be simple but powerful, OmniTrust helps you save time on implementation and in daily use, streamlining your workflow and giving you complete confidence that no surprises will be discovered during an audit.
OmniTrust is a comprehensive solution composed of software and services, including:
- OmniAccess
- Authorization - who can access the system and what they can access - controlled via roles, which have permissions, and members allocated to those roles, who can also be allocated to individual workstations
- Authentication - the source of users (e.g. Windows domain, Active Directory)
- Synchronization - define how the System Audit Trail is synchronized and set up Central Management (optional license needed)
- Signing and Reason - define events that require a user's signature and/or reasons for doing the event
- OmniTrail
- View and audit system and user activity in an OmniTrust environment.
- System audit trail system for tracking system events and security controls
- Record audit trail through software application interface for tracking individual measurement records
- Central Management (optional)
- Set up multiple instruments simultaneously and view system audit trails across platforms
- Reduces manual errors and simplifies internal and external audits
Services include Installation Qualification (IQ) and Operational Qualification (OQ)—two critical stages outlined in USP <1058> for ensuring that analytical instruments are properly installed and operate as intended in regulated environments.
In addition, as part of the OmniTrust solution, we offer regulated environment compliance tests, onsite setup, and configuration, all designed to support a robust qualification and validation process aligned with global standards.
Why OmniTrust?
Built for data integrity. Trusted for compliance.
Compliance made simple: secure, scalable, audit-ready
Streamlines workflows and reduces the administrative burden for data integrity associated with compliance, for all of your MP portfolio:
- Simplified adoption with a unified user interface and workflow throughout OmniTrust family
- Up and running from as little as 60 minutes
- Flexible role configuration for different environments (R&D/QC) and single sign-on/e-authentication
- Access and permission control, with comprehensive overview (at a glance) of user management
- Electronic signatures
- Comprehensive documentation for compliance validation
- Convenient audit history review in one place through OmniTrail
Trusted Expertise: from deployment to long-term compliance
Our decades of experience in 21 CFR 11 regulations and regulatory test scripts guarantees peace of mind, efficiency, and confidence in regulatory compliance On-site setup for local and central management, ensuring seamless integration:
- Options for us to setup your roles and permissions
- We support and fast track your system into operation within days
- We accelerate network setup for centrally managed roles and permissions and audit review
- Class-leading compliance support and advice from our certified experts
Centralized Management: for scalable data integrity
Convenience of centralised audit trails and remote role/user management:
- Configure once, deploy everywhere
- Saves time and effort by not having to configure several individual instruments
- Configure once, deploy many times - across multiple MP instruments, anywhere
- Prevents manual errors when deploying roles and permissions on multiple MP instruments
- Combined audit trail data review that supports cross-technique traceability from any authorized PC, not just the instrument terminal
It’s so configurable that it’s perfect. Being that open, it’s perfect, it allows you to do all the roles you need”
Join the OmniTrust Family
OmniTrust is designed to work with the following application software versions or higher (please also check the relevant application software release notes or software update notifications):
- ZSXplorer 2.x
- Aeris Instrument Suite version 1.6
- Data Collector version 7.x
- Data Viewer version 2.x
- HighScore (Plus) version 5.x
- Mastersizer Xplorer 4.x
- NanoSight Xplorer 2.x
Which products can be used with OmniTrust?
If you are already a user of OmniTrust and want to make the most out of the compliance tools and be able to tailor them to your workflow, sign-up to the OmniTrust e-learning now.