Blog Posts
- 21 CFR Part 11
- Accretive Model
- audit trail
- Case Study
- Cloud Qualification
- continuous validation
- data integrity
- EDMS
- ERP
- GLP
- IT Infrastructure Qualification
- IT Quality Management
- Laboratory Systems
- managed service
- Master Validation Planning
- New Facility Validation
- Paperless Validation
- partnership
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- Risk Based Validation
- Sterile Manufacturing
- Success Story
- Test Automation
- Validation
- Why xLM?
- xLM
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 It is not possible to qualify an infrastructure where changes are released without release notes with such an outdated mindset and toolset.
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.
Life science companies are adopting the Cloud (Public, Private, Hybrid) but are constantly faced with the "Validation Challenge": How can I validate the Cloud Stack (IaaS, PaaS, SaaS) to meet the various GxPs?
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, August 19, 2016 – ValiMation, Inc., the first managed service provider for delivering continuously validated cloud apps, today announced a partnership with ServiceMax, the leader in cloud-based field management solutions, to provide customers with complete validation life-cycle management for all ServiceMax apps.
Compliance & Validation
xLM managed service is designed for Cloud App Validation. It is a validated automated test platform to “certify” your cloud app. This certification can include:
- Initial Validation
- Patch & Upgrade Validation
- Regression Testing
- New Feature Testing
- Performance Testing
- Security Testing
- Continuous Validation (a unique and bonus feature)
Problem Definition
A large pharmaceutical conglomerate was establishing a brand new, state of the art sterile manufacturing plant. The facility design had to comply with the requirements of the United States Food and Drug Administration (FDA), the Japanese Ministry of Health and Welfare (JMHW) and the European Agency for the Evaluation of Medical Products (EMEA). However, the effort had the following major stumbling blocks....
Problem Definition
A GLP laboratory within a large research establishment comprised of several laboratory systems that are used in GLP studies. This project involved development of a master plan and the compliance infrastructure for the entire GLP organization. It also involved development and implementation of life cycle deliverables for several laboratory systems. The validation effort had the following major stumbling blocks.....
Problem Definition
A company, with several facilities across multiple continents, was looking to qualify their network infrastructure. The qualification effort was underway for over six months prior to ValiMation’s involvement, and the project going nowhere fast. The qualification effort had the following stumbling blocks....
Software Integration and Qualification of an MS SharePoint based knowledge management infrastructure for a large Pharmaceutical Manufacturing Facility. The system provides web based workflow, collaboration features and an electronic repository for electronic documents / files for various departments within the facility. This includes equipment/hardware/software manuals, validation documentation, CAD drawings, PLC programs, packaging documentation, batch records, stability reports, etc.. The solution incorporated ValiMation’s Application Implementation Methodology (AIM) for rapid deployment.
Problem Definition
A sterile manufacturing facility was looking for consulting help to assist their Information Systems (IS) department to support the validation / compliance department. The consulting assistance was needed for the following reasons...
Problem Definition
A particular sterile manufacturing company was using BPCS as an ERP system for over 10 years. However, the system was not validated and the company was using manual processes and manual documentation to meet many compliance needs. They were mandated to validate their ERP system by the EMEA....
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.