GxP and Part 11 Compliance with Egnyte’s Cloud Solutions

GxP and Part 11 Compliance with Egnyte’s Cloud Solutions

Life Sciences Regulatory Compliance Software, Qualification, and Services

Egnyte for Life Sciences makes it easy to manage regulated data, like SOPs, study reports and batch records, in a single, compliant repository. Our validation and software solutions enable life science companies to meet regulatory requirements with ease while avoiding tougher non-compliance penalties.

Part 11 and Annex 11 Compliance & Data Integrity

Part 11 and Annex 11 Compliance & Data Integrity

When storing and managing GxP-regulated documentation, the Egnyte for Life Sciences software and cloud solutions help comply with regulatory requirements, like Part 11 and Annex 11. Our industry-specific platform has features and functions that meet these regulations for life science regulatory compliance, including:

  • Audit trails to see exactly how a system is being used and who is using it.
  • Historical file checksum values that prove Data Integrity over time to meet Part 11 and Annex 11 requirements and compliance.
  • User access controls that ensure only the right people have access to the right content.

e-Signature - we integrate with Part 11 compliant e-signature and digital signature vendors, like AdobeSign and DocuSign.

Qualification & Validation Package

Unlike our conventional software, the Egnyte for Life Sciences compliance software is put through a rigorous set of qualifications. This process generates a set of documentation - our validation package - that supports a customers validation and implementation of the platform.

This life sciences validation package can be procured alongside our software and is composed of the following items:

  • Functional Requirements Specifications
  • Platform Qualification
  • Software Installation Qualification
  • Operational Qualification
  • Traceability Matrix
  • ERES assessment
Ongoing Compliance

Ongoing Compliance

One of the many benefits of cloud-based compliance software is that it continually improves. For validated environments, however, continuous updates can be problematic. Egnyte has a unique approach to accommodate new releases, while still ensuring a strong GxP compliance envelope (including Annex 11 and Part 11 data integrity) for regulated data. This involves:

  • Furnishing a test environment so clients can review new features without impacting a production environment
  • Delaying releases of GxP production environments to provide a more consistent environment
  • Providing risk assessments for all new releases for complete transparency
  • Allowing a remote audit of our SOPs once per term to ensure proper alignment

Proof of Validation

There are times when proof of validation is required. This has historically meant a mad scramble to create and deliver the proper documentation. Egnyte for Life Sciences takes the hassles out of the process with the Validation Portal. It provides fast and easy access documentation and test results that are updated daily.

The portal includes:

  • Daily Production Validation Results
  • Detailed Documentation of the Validation Package
  • Daily Production Qualification Reports
  • Daily Risk Assessment Reports
Proof of Validation

Additional information

GxP Risk Assessment

GxP Risk Assessment

A checklist that provides a framework for evaluating which software should or shouldn’t be validated.

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