"Continuous validation is providing documented evidence to certify that a cloud app not only met the pre-established acceptance criteria, but “continuous” to meet thus mitigating the risk of unknown changes."
CONTINUOUS QUALIFICATION FOR AWS OR MICROSOFT AZURE - HOW IS IT DONE?
The question is "Can Amazon AWS or Microsoft Azure be qualified so that Life Science companies can run validated apps on it?"
Cloud releases updates and changes at such great velocities that leaves all validation specialists continuously wondering on how to qualify it. Traditional strategies including GAMP 5 was never designed to address continuous changes. These models were designed for a "waterfall" world and not an "agile" one. It is not possible to qualify an infrastructure where changes are released without release notes with such an outdated mindset and toolset.
Does this mean that the Life Science world should stay in the dark ages with their paper based, wet signature toolset and a brick and mortar data center? You need continuous Qualification for Continuous Compliance that works better than ever, just like the Cloud!
Here is a step by step guide to Continuous Qualification:
Step 1: Design your BASE Cloud Infrastructure (combination of IaaS / PaaS)
Step 2: Divide your BASE into logical Services
Core Services (e.g. Networking, Compute)
Management Services (e.g. Auditing, Monitoring)
Step 3: Build your DEV BASE IaaS/PaaS. Finalize and test your configuration.
Step 4: Develop a Qualification Plan / Governance Framework
Step 5: Subscribe to our IaaS / PaaS Qualification Service. We have built a sophisticated infrastructure to qualify Microsoft Azure or AWS Services. Our Service Qualification coverage is unmatched. We post the following on a "Weekly" basis on our customer portal:
Service Qualification Plan
Service Requirements Specification (with Comprehensive Coverage)
Service Risk Assessment
Service Qualification Protocols & Execution Reports
Service Qualification Summary Reports
Service Release Certificates
Step 6: You don't have to Qualify any Service. We will do that for you on a continuous basis. Our "continuous" qualification platform for each Service will provide documented evidence that your Service continuous to work as designed (irrespective of many changes pushed by the Cloud Vendor)
Step 7: Deploy PROD BASE IaaS/PaaS
Step 8: Add or Modify Services to build out your Cloud under Change Control
Be More Informed
CONTINUOUS VALIDATION - HOW IS IT DONE? - PART 1: INFRASTRUCTURERead More -->
CONTINUOUS VALIDATION - HOW IS IT DONE? - PART 3: PROCESS FLOWRead More -->
CONTINUOUS VALIDATION - HOW IS IT DONE? - PART 2: VALIDATIONRead More -->
xLM has introduced "eXtreme", "agile" and "continuous" validation life cycle management that is rigorous enough to meet FDA, EMA regulations and at the same time cost effective. Read More -->