21 CFR Part 11

Total Confidence. Absolute Integrity.

21 CFR Part 11 establishes requirements for electronic records and electronic signatures in regulated industries. This includes pharmaceuticals, biologics, medical devices, and food products (human and veterinary). Companies in these industries that do business in the United States, as well as providers of raw materials and components to pharmaceutical companies and contract labs commissioned to perform analysis work, must all operate to ensure that electronic records and electronic signatures are trustworthy and reliable.

Key requirements of 21 CFR Part 11:

  • Electronic records must be created, maintained, and archived in a way that ensures their authenticity, integrity, and confidentiality
  • Electronic signatures must be used in a way that is equivalent to handwritten signatures
  • Companies must have procedures in place to control access to electronic records and electronic signatures
  • Companies must have a system in place to audit electronic records and electronic signatures

21 CFR Part 11 is designed to protect the safety of consumers by ensuring the accuracy and reliability of electronic records and electronic signatures. By complying with these requirements, companies can help to ensure that their products are safe and effective.

OmniTrust software - For regulatory compliance and data integrity

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.

Malvern Panalytical 21 CFR Part 11 compliant products

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

Product21 CFR Part 11 Compliant Software
AerisAeris Instrument Suite
MicroCal DSCMicrocal DSC Software
Malvern Access Configurator
EmpyreanEmpyrean XRD Suite
Data Collector version 7.x
Data Viewer version 2.x
HighScore (Plus) version 5.x
Epsilon 1
Epsilon 4
Epsilon Software
Mastersizer 3000OmniAccess
Mastersizer Software
Morphologi 4
Morphologi 4-ID
Morphologi Software
Malvern Access Configurator
SpraytecSpraytec 2.x (and above)
X’pert3Data Collector version 7.x
Data Viewer version 2.x
HighScore (Plus) version 5.x
Zetasizer UltraOmniAccess
ZSXplorer 2.x
Zetasizer ProOmniAccess
ZSXplorer 2.x
Zetasizer LabOmniAccess
ZSXplorer 2.x
ZetiumZetium Software

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