Change Control

Challenge

• Unmanageable dependencies: A single change, a component, a material, a process step, can affect dozens of documents, certifications and approvals that are nearly impossible to capture manually.
• Hidden risk: Affected sections in technical files, risk analyses or validation documents get overlooked, and only become a problem during an audit or with the regulatory authority.
• Time effort: Manually analysing the impact of a change ties up regulatory experts for days, and delays the entire development process.

Solution

• Entire product documentation searchable: Technical files, risk analyses, validation protocols, bills of materials and certification documents are loaded into MAIA and immediately searchable in context.
• Impact analysis in seconds: MAIA identifies all documents, requirements and approvals affected by a planned change, with source references.
• Document changes completely: MAIA helps to capture the change and its implications in a structured way, as the basis for the formal change control process.

Result

• Completeness: No affected section gets overlooked, even in extensive technical files.
• Speed: Impact analyses that used to take days are completed in hours.
• Audit confidence: Changes are fully documented and traceable at any time.

Prompt Examples

1. Impact analysis: "Which documents and certifications are affected by the change to [component/material/process]?"
2. Regulatory impact: "Does the change to [X] need to be re-evaluated or reported under MDR?"
3. Document checklist: "Which documents in the technical file need to be updated due to the change to [X]?"
4. Comparison: "What has changed compared to the previous version of [product/component] and what are the regulatory implications?"

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