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Vorschlag CAPA: 1) Charge L2614–L2617 sperren, 2) Lieferanten-Audit beim Dichtungslieferanten innerhalb von 30 Tagen, 3) SOP **QC-117** Revision 4: zusätzliche Eingangsprüfung pro Charge.
对 SOP QC-117 第 4 版有疑问:每批入厂检验是否包含粒径分布?当前流程仅做目检。
**Confirmed**: incoming inspection per batch includes particle-size distribution and dimensional check. **CAPA owner**: J. Müller. **Target close**: 30 days.
CAPA-2026-0214 — Abweichung Dichtungscharge
- Chargen L2614–L2617 bis zum Abschluss der Ursachenanalyse sperren
- Lieferanten-Audit beim Dichtungslieferanten innerhalb von 30 Tagen
- SOP QC-117 Rev. 4 — Eingangsprüfung pro Charge ergänzen (PSD + Maßprüfung)
- Verantwortlich: J. Müller (Stuttgart QA) · Zielabschluss: 2026-03-16
Transkript-Paket beim Session-Export angehängt — alle Sprachversionen im Audit-Record.
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| Capability | InterMIND | Zoom | Microsoft Teams | Webex | Google Meet |
|---|---|---|---|---|---|
| Synchronous AI voice translation in regulated meetings Sub-second latency, 19 languages, captured on the audit record. | Yes | Partial | Partial | Partial | No |
| AI voice translation in large meetings / Town Halls Teams Interpreter Agent (Copilot) is disabled in Town Halls as of April 2026. | Yes | Partial | No | No | No |
| Verifiable translation-quality benchmark per language pair Reproducible methodology, public scores — quality is proven, not asserted. | Yes | No | No | No | No |
| On-premise / dedicated-tenant translation engine Own engine; private-tenant deployment in progress for regulated accounts. | Partial | No | No | No | No |
| Chat translation that preserves regulatory formatting Bold change identifiers, numbered procedure steps, quoted SOP clauses. | Yes | Partial | Partial | Partial | No |
| Live shared protocol — per-viewer language with diff Every participant reads CAPA / change wording in their language with diff on every edit. | Yes | No | No | No | No |
| Office + PDF document translation on demand in-session Deviation reports, supplier certificates, draft SOPs — layout preserved. | Yes | No | No | No | No |
| Per-language audit-grade transcript bundle for the audit record Per-utterance source + target language with timestamps, exportable for attaching to deviation / CAPA / change-control records. | Yes | No | No | No | No |
| GxP qualification package (CSV, IQ/OQ/PQ documentation) On the roadmap; available for enterprise tenants on request. | Partial | No | No | No | No |
| EU data residency option | Yes | Yes | Yes | Yes | Yes |
| Enterprise scale (10,000+ attendees, SCIM, AD/Entra) Pair InterMIND with Zoom/Teams/Webex for one-way fan-out broadcasts. | No | Yes | Yes | Yes | Partial |
Where competitors are stronger: Zoom, Teams, Webex, and Google Meet scale to thousands of attendees, ship enterprise IT integrations out of the box (SCIM, AD/Entra, MDM), and have hardened SOC 2 / ISO 27001 / HIPAA postures the industry already trusts. If you need a single broadcast tool for the whole company, none of them are the wrong choice — they are the safe default.
Where competitors fall short: Teams Interpreter Agent (Copilot, late 2025) does not work in Town Halls — only in standard meetings. Zoom requires you to staff human interpreters via the interpretation channel. Webex AI Assistant offers translated captions but not synchronous voice translation in regulated workflows, and none of the four publishes a verifiable per-language-pair translation-quality benchmark. None translates Office/PDF attachments live in the session, and none captures a per-language audit-grade transcript bundle for attaching to a deviation, CAPA, or change-control record. The conversation layer next to the DMS is the gap.
Based on public documentation as of April 2026. Verify current status with each vendor before procurement, particularly around Town Halls / large-meeting feature parity, on-prem options, and qualification packages.
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