Cloudneeti launches continuous GxP compliance assurance for Microsoft Azure, Office 365 and Amazon Web Services (AWS)

Cloudneeti provides continuous cloud security and compliance assurance for your public cloud workloads on Microsoft Azure, Microsoft Office 365 and Amazon Web Services addressing the customer’s part of the shared responsibility for FDA 21 CFR Part 11 and Part 820.30 regulation controls.

What is GxP Compliance and Who is it for?

GxP is a collection of quality guidelines and regulations created to ensure that bio/pharmaceutical products are safe, meet their intended use, and adhere to quality processes during manufacturing, control, storage, and distribution.

Regulated industries including food, pharma, medical devices, and cosmetics are impacted by GxP. GxP guidelines and regulations are global; some of the popular regulators include the FDA in the US, TGA in Australia, and HS-SC in Canada. GxP includes varied regulation sets, but the most common are GCP, GLP, and GMP:

GxP regulation set covers Pharma and Life Sciences, typically

  • Good Storage Practices (GSP)
  • Good Auditing Practices (GAP)
  • Good Review Practice (GRP)
  • Good engineering practice (GEP)
  • Good automated laboratory practice (GALP)

The regulation focusses on

  • Traceability: The ability to reconstruct the development history of a drug or medical device.
  • Accountability: The ability to resolve who has contributed what to the development and when.
  • Data Integrity (DI): the reliability of data generated by the system. DI could be determined by the following activities:
    • Identifying the data generated by the system during critical processes (data flow diagram)
    • Defining the DI requirements (e.g. ALCOA data attributes) during the lifecycle of data
    • Identifying the risks and mitigation strategies (e.g. technical or procedural controls) to avoid DI breaches.

How does Cloudneeti help?

Customers use Cloudneeti to achieve and maintain GxP compliance, especially customer’s part of shared responsibility to FDA 21 CFR regulation.

  1. Achieve GxP compliance: Various teams within the customer’s organization (e.g. CISO, Information Security and Application Dev teams) start with the list of cloud security best practices, baseline their security posture, prioritize risks and start on the implementation processes. Customers using Cloudneeti report that total time to achieve overall compliance reduces by >50%.
  2. Maintain GxP Compliance: Businesses are increasing the speed to realize value faster. Customers using Cloudneeti can track compliance deviations as frequently as every cloud deployment multiple times in a day or at a minimum at least once a day. Using various Cloudneeti features like daily trend reporting, daily change notifications customers would keep up and maintain continuous compliance.

What does Cloudneeti cover?

Cloudneeti provides continuous cloud security and compliance assurance for your public cloud workloads on Microsoft Azure, Microsoft Office 365 and Amazon Web Services addressing the customer’s part of the shared responsibility in the following areas for FDA 21 CFR Part 11 and Part 820.30 regulation controls.

Cloudneeti Dashboard for GxP

 

Continuous monitoring for GxP Regulation controls are now available for the following control categories

  • 11.10 (b) – Network Protection
  • 11.10 (c) – Data Protection
  • 11.10 (c) – Data Backup and Retention
  • 11.10 (d) – Administrative Access
  • 11.10 (d) – Access reviews
  • 11.10 (e) – Audit Trails
  • 11.300 (a) – All password related policies
  • 11.10 (g) – User access management
  • 11.10 (h) – Application Security & Vulnerability Management
  • 820.30 (i) – System Patching

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