21 CFR Part 11

Created by Malvern Panalytical, OmniTrust is an instrument-agnostic, flexible and scalable solution that can be tailored to meet the specific needs of any organization. It is a powerful tool that can help you to improve your data integrity and compliance with regulatory standards.

OmniTrust complies with 21 CFR Part 11 by providing several features that help you ensure the authenticity, integrity, and confidentiality of electronic records and electronic signatures. These features include:

• Role-based access control
  OmniAccess grants users access to OmniTrust based on their roles within the organization. This helps to ensure that users only have access to the data and functions that they need to perform their jobs.
  
  
• Audit trail
  OmniTrail maintains an audit trail of all activity within the system. This audit trail can be used to track changes to electronic records and to investigate any potential security breaches.
  
  
• Electronic signatures
  OmniTrust supports the use of electronic signatures. Electronic signatures that are created using OmniTrust are equivalent to handwritten signatures.
  
  
• Data encryption
  OmniTrust encrypts all data at rest and in transit. This helps to protect data from unauthorized access.

In addition to these features, OmniTrust also provides the following features that help to improve data integrity:

• Data validation
  OmniTrust validates data as it is entered into the system. This helps to prevent errors from occurring.
  
  
• Data recovery
  OmniTrust can be used to recover data that has been lost or corrupted.

Our software, including our OmniTrust package, enables the following products (with appropriate local IT infrastructure) 21 CFR Part 11 compliance, ALCOA+ data and USP <1058>, which outlines the entire process of analytical instrument qualification.