Global Biopharma Leader Commercial MDM SQA Audit
Master Data Management Software Quality AssuranceChallenge
A global biopharma leader migrated their Commercial MDM applications from Informatica to Reltio. They expressed concern that the work performed to document and test the new platform created both functional and potential compliance risks.
They asked Osprey Life Sciences to perform an audit focused on documentation, processes, and SQA best practices to determine the scale of the issue and potential corrective actions with the expectation that remediation would likely be the next step.
“There was concern that the client’s documentation had both functional and compliance risks.”
237
Unique Assets Audited
1,177
Audit Findings
13
Deficiency Categories
65% of findings were remediated by Osprey’s audit team in real-time.
Documentation is now a true reflection of the current state of the client’s MDM system.
Solution
Osprey Life Sciences developed a plan of action for auditing the assets, including the creation of an audit framework for capturing results and findings.
We then performed a multi-faceted audit covering the Documentation process as well as the corresponding documentation. In addition, we developed an Audit framework including Strategy, Test Plan, Test Cases, Traceability, and an Execution plan that can be utilized for current and future activities.
Project deliverables included a full set of documentation including audit findings, documentation review results, and the aforementioned Audit framework.
Osprey Responded With the Following Actions:
- Overhauled the SharePoint site to fit into a new SDLC taxonomy that best suited the client
- Eliminated duplicate assets and provided guidance on best search practices
- Trained teams on the new taxonomy, best practices for file naming conventions, and preventing duplicates
- Corrected content gaps in documentation by looking at the system’s configuration and meeting with various client teams to replace gaps with the appropriate content
- Defined an Audit Framework that helped the client teams make use of templates, provided best practice guidelines that were predictable and repeatable, and addressed process gaps
~ 6 Weeks Duration
Executed audit on targeted assets to collect information to support remediation recommendations
~ 8 Weeks Duration
Based on audit findings, targeted remediation activities with the biggest return on investment (ROI)
$$ Cost – Time & Materials
Time and materials billing model that depends on the remediation activities being addressed
Iterative Delivery Approach
- Audit
- Remediation Recommendations
- Remediation Activities
- Summary Report
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