FDA put out its DRAFT guidance on Data Integrity and Compliance with cGMP in April 2016. This guidance is important because we come to understand FDA's thinking on Data Integrity.
The question is "Can Amazon AWS or Microsoft Azure be qualified so that I 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 It is not possible to qualify an infrastructure where changes are released without release notes with such an outdated mindset and toolset.
This blog post is Part 2 in this series. What are the key steps involved in continuously validating a Cloud App? (click here for Part 1).
The above diagram depicts the key elements of a Continuous Validation Program for a Cloud App. One has to bear in mind that the underlying IaaS and PaaS infrastructure is constantly changing. In fact, the Cloud App itself is continuously changing. In the new cloud world very rarely you are given the option of pinning to an "ancient" version. Thus this Continuous Validation Framework is designed to mitigate these risks and ensure that your cloud app is maintained in a validated state.
Most important and time consuming piece of any validation stack are test scripts (Installation, Operational, Performance, etc..), test executions and test results. Validation is all about authoring test scripts, executing and documenting test results. Whether testing is manual or automated, a lot of data is collected during validation. Only in rare cases, one will be able to obtain real-time data on test execution, testing deviations or test coverages. Such information will enable more efficient management of validation efforts and reduce costs. A well designed system will provide useful dashboards and metrics to project managers as well as validation personnel.
PHILADELPHIA, PA (PRWEB) SEPTEMBER 07, 2016
xLM, LLC, the first managed service provider for delivering continuously validated cloud apps, today announced a partnership with Cloudbyz, a provider of eClinical apps.
In the GxP world, test execution reports for any validation exercise contain most important artifacts that serve as evidence. Audit trail of 'who did what? at what time?' are captured in the form of actions and results with time stamps, and most frequently with screenshots. In most test automation frameworks that are utilized in validation, a major gap is the presentation of this evidence that can meet the scrutiny of any inspector.
Life science companies would love to get rid of inefficient and costly validation processes, may it be electronic manual tests or even worst, paper based manual tests. The only answer to this problem is "test automation". But the challenge is that if you use test automation for validation, then you need to keep your test automation infrastructure and processes also in a validated state. But the test automation world is too complex for validation and even more difficult to keep it in a validated state given the nature of frequent changes, upgrades and a myriad of tools used.
Test Automation field is evolving with unprecedented pace to avoid pitfalls and overcome challanges of design complexity, selecting appropriate tools, agility and efficiency. Model Based Testing (MBT) could be a breakthrough for the industry as MBT tools now offer comprehensive solution for integrated test design and automation. At xLM, we have unearthed MBT solutions that overcome most challenges faced in traditional test automation.