IBM Clinical Development EDC Validation


The Challenge

A global organization that develops, manufactures and sells diagnostic instruments and related software needed validation for their cloud based Electronic Data Capture “EDC” platform, “IBM Clinical Development” to help reduce the time and cost of clinical trials.  Their clinical sites would enter study data into the software and it would expedite their data review and processing. The data could be analyzed before submitting Case Report Forms (CRFs). EDC system validation has unique data integrity aspects that must be considered.

The client wanted assistance from a company that had experience validating a Software as a Service (SaaS) platform. Their data would eventually be analyzed by Microsoft R so familiarity with that software could provide added benefit.   Microsoft R is a platform which performs data manipulation and statistical analysis. The client used it to perform multiple complex calculations on instrument data and CRFs.

The Solution

Performance Validation had just finished validating Microsoft R for the client successfully.  That solution is also a “SaaS” which was validated within their time constraints and complied to their Quality Assurance program.  Validating a SaaS platform is a newer challenge for organizations since the application is not physically installed at the clients site and there is potential that upgrades/modifications are deployed by someone not within your organization.  The vendor of the software and/or host of the application need to be thoroughly evaluated and a Service Level Agreement (SLA) agreed upon stating access to confidential data in the system is limited to approved employees and not updated without a change control procedure. The installation qualification becomes smaller since it outlines the thin client portion of requirements and not the larger virtual infrastructure. Our familiarity with the data and business operations of the client really allowed us to be efficient in the EDC validation project. 

PV was determined to be a logical, cost effective choice for bringing their IBM Clinical Development application into compliance.   The client benefited from a remote worker writing the supporting documentation and executing without incurring travel costs. After the initial User Requirements Specification was drafted, the decision was made to use the clients new validation templates.  PV determined this was acceptable and were able to adapt the changes to what was provided. Collaborating with a member of their Quality Assurance department occurred to ensure their templates were completed consistently without future rework.

The Results

The project was completed on schedule and within budget.  Correspondence for the project consisted of phone and email updates.  The client wanted to leverage vendor testing where possible and made the focus of Customer and Functional Requirements based on the Roles used within their organization.  PV adhered to the newly created client templates and worked with QA to ensure an expedited inspection at the end of the project. 

Have a question on Computer Systems Validation, or application of Data Integrity principles, contact Kevin Marcial.