CASE STUDY
Automated Audit Preparation in MedTech with AroTrace
AI Automation for Compliance, Traceability and DHF Assembly
In the medical device industry, regulatory compliance is non-negotiable. A European Class III infusion pump manufacturer faced mounting pressure to deliver complete Design History Files (DHFs) with every release, proving end-to-end traceability across requirements, risks, tests and approvals. Manual audit preparation consumed weeks of engineering effort, introduced errors and slowed down innovation. To solve this, the company partnered with Arorian to deploy AroTrace, combining orchestration and AI automation to create an accurate, efficient and auditor-friendly workflow.
THE CHALLENGE
Manual, Error-Prone Audit Preparation
Even with Codebeamer for ALM and Windchill for PLM in place, the manufacturer faced a fragmented and labor-intensive audit workflow:
1. Document Overload
Each regulatory milestone required over 1,500 documents to be collected, checked and cross-referenced.
2. Heavy Engineering Burden
Audit prep consumed 25–30% of the engineering team’s time every quarter, reducing focus on design and innovation.
3. Traceability Gaps
Inconsistent links between ALM, PLM and risk systems triggered audit findings and forced costly remediation.
The organization needed an integrated, automated solution to assemble audit-ready evidence while ensuring complete traceability.
THE SOLUTION
Automated Audit Preparation with AI Summarization
Arorian implemented AroTrace automated audit preparation, orchestrating ALM–PLM data and leveraging its built-in AI automation layer, to streamline audit preparation, improve clarity and accelerate workflow.
1
Data Orchestration
AroTrace pulled requirements, test results, approval records and risk items across systems into a single workflow.
2
Evidence Pack Assembly
Automatically generated an audit-ready package (DHF/SSPP/PPAP), ensuring all trace links and approvals were complete.
3
AI Cover Note
AroTrace produced a concise summary of release scope (requirements, % test coverage, risk status), giving auditors an immediate high-level view.
4
Version Control
Each evidence pack was frozen and archived in Windchill, ensuring reproducibility for future inspections.
THE OUTCOME
Faster, More Reliable Compliance
With orchestrating ALM–PLM data and the AI automation capabilities of AroTrace, the medical device manufacturer realized measurable improvements:
70% Faster Audit Preparation
Audit evidence packs that once took weeks to assemble were now generated within days, accelerating release readiness.
Elimination of Traceability Gaps
Automated data orchestration ensured that every requirement, test and approval was linked, removing the missing connections that previously caused audit findings.
More Engineering Time for Innovation
By removing the manual burden of compiling and checking documents, engineers were able to focus on design and development work instead of clerical tasks.
Improved Auditor Confidence
Auditors praised the standardized, consistent evidence format, improving trust and confidence.
Start Your Proof of Concept with AroTrace
Validate how AroTrace can transform audit preparation and compliance management in your engineering workflows.
DURATION
2–4 weeks, depending on scope and complexity
COMMITMENT
No obligation to continue if success criteria are not met
AGREEMENTS
NDA and Proof of Concept Statement of Work (SOW) signed prior to kickoff
SUPPORT
Full access to Arorian’s engineering and product teams throughout the POC
ABOUT ARORIAN
Arorian is a global leader in providing digital solutions and services that drive transformation and growth for businesses across various industries. With a focus on innovation and excellence, Arorian delivers unparalleled value to its customers by harnessing the power of technology to solve complex challenges.
