Improve your data integrity and be 21 CFR Part 11 compliant with OmniTrust software

OmniTrust is Malvern Panalytical’s new compliance management software, designed to help pharmaceutical companies keep on top of regulatory requirements. Experience it for yourself in this live launch
event. Hear from the OmniTrust team as they share:

• The vision behind OmniTrust
• A demonstration of OmniTrust software tools in action
• Best practices for optimizing workflows and managing risk in complex environments

Total Confidence. Absolute Integrity. 

Analytics you can trust. OmniTrust data integrity solutions, supported by Amplify Analytics, can help you get lifesaving pharmaceutical products to market faster. Discover how we can help ensure you’re applying the right analytical methods at the right time – to deliver reliable data that informs critical development and manufacturing decisions. Applying the right analytics in order to ensure data integrity, it’s essential to deploy the right analytical techniques in the right way and at the right time. Upstream decisions about technologies and methods are therefore key to generating robust data which can be trusted to inform product quality. Our panelists will discuss the approaches we apply within Amplify Analytics to ensure identification and analysis of the Critical Material Attributes and Critical Process Parameters which must be considered to ensure product integrity. 

Delivering data you can depend on. 

Once the right techniques and methods have been identified, the next challenge is how to implement these solutions to generate data which can be trusted. In the heavily regulated pharmaceutical environment, a risk-based approach to data governance is essential to manage the requirements of compliance, assurance and science. In this section, we will discuss the practical steps needed to balance speed to market with data integrity.   

OmniTrust: protecting the integrity of your analytical workflows. 

Accelerating time to market while ensuring compliance with regulatory requirements is key to succeeding in today’s pharmaceutical industry. Learn how Malvern Panalytical helps customers in the regulated environment minimize the risks associated with data integrity, from instrument qualification to compliance and auditing software. Your questions answered. Stick around for our live question and answer session where our panel will tackle your questions about OmniTrust, and how we can help you solve key analytical challenges, reduce risks, and help you accelerate your product to market.

Using OmniTrust, pharmaceutical companies can seamlessly reduce their administrative burden whilst safeguarding product safety and compliance standards. Designed to work across single or multiple Malvern Panalytical systems, OmniTrust is a comprehensive solution which ensures data integrity and 21 CFR Part 11 compliance, in order to:

• Reduce the burden of validation across multiple systems
• Manage risk in complex pharmaceutical environments
• Optimize workflows for improved efficiency
• Guarantee complete traceability of users and their activities over multiple product lines and workstations
• Provide absolute confidence for internal and external audits
  

You’ll also hear from Gregg Imrie of contract research organization Concept Life Sciences about his experience of the configuration and validation capabilities of OmniTrust for a busy laboratory, providing drug discovery and development services to the pharmaceutical, biotech, diagnostics and materials sciences industries.

Who should attend?

• Pharmaceutical scientists working in the regulated environment
• Analytical scientists working to 21 CFR Part 11 or GMP Annex 11 regulations for data integrity
• Anyone working with Dynamic Light Scattering or X-ray Diffraction analysis within the pharmaceutical industry

What will you learn?

• Learn about OmniTrust, Malvern Panalytical’s new software solution for the regulated environment
  
• Understand how OmniTrust improves laboratory efficiency by adapting to your workflows
• Learn how to configure OmniTrust to suit your requirements
• See how OmniTrust delivers confidence for the audit process