Annex 11 §14 is a control requirement, not a technology requirement. NB auditors I've worked with apply the same hierarchy: integrity of the record beats integrity of the signature.

#AuditReady #QualityManagement #DataIntegrity

We’re excited to announce a new strategic partnership between Elligint Health and Laguna Health, bringing conversational AI capabilities into the care management ecosystem our clients rely on.

Read the full pr: bit.ly/4jH2tyH

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Class I recall from a Sodium Chloride supplier, propagating through every kit containing that ampule. If your QMS can't trace that cascade in one connected workflow, the FDA letter finds it first.
api.fda.gov/device/enforcement.json?search=reca…

#QualityManagement #Traceability #SupplierQuality

The Aisys CS2 auto-O2-switch recall is why post-market signal must flow back into the design history file, not sit in a siloed complaint log.

#DesignControl #CAPA #QualityManagement

Aisys CS2 Et Control in a Class II recall means the failure mode sits somewhere the design FMEA didn't exercise. Trace it back, that's where the belongs.

#CAPA #QualityManagement #RiskManagement

gap you find yourself is a fix. Gap the auditor finds is a finding. Any tool that surfaces audit-risk holes before the visit earns its keep, pretty checklists aren't enough.

#AuditReady #QualityManagement #RiskManagement

Preparing for ISO/IEC 17020? Focus on the basics: qualified staff, impartiality, solid methods, and traceable records.
Prove your agency's competence.

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#AccreditationReady #ISO17020 #InspectionBody #QualityManagement #IASAccreditation

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Quality 4.0 and #ArtificialIntelligence
Technologies, Metrics and Practice for the Inclusive and Smart Factory
dr JOANNA ROSAK-SZYROCKA and Radosław Wolniak
Read the intro doi.org/10.4337/9781...
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Datex-Ohmeda's Aisys CS2 just got pulled for a firmware fault that silently flips the device into backup O2 control. The kind of failure mode that hinges on whether risk files and CAPAs actually connect.
api.fda.gov/device/enforcement.json?search=reca…

#CAPA #QualityManagement #RiskManagement

Halyard's Class I started as Spectra's ampule recall. Supplier NCs siloed from finished-device risk files are post-market surprises in the making.

#RiskManagement #SupplierQuality #QualityManagement

30 min slides, 25 min "but here's why OUR gap-analysis template is better." Actual learning: the 5 min Q&A. ASQ chapters and notified body workshops beat vendor pitch decks every time. Anyone else ditching these? 🫠📋 #ISO13485 #MedTech #QualityManagement #RegulatoryAffairs #CAPA #qmsWrapper

80% of serious outages are preventable process failures, not hardware faults or simple operator error. Fix the written procedure to prevent the next incident: https://smbadvisor.management/root-cause-analysis/ #QualityManagement #ProcessImprovement #DevOps #SRE

Xtreem Pulse has their 510(k). Now the quality system matters, how fast can post-market signals feed back into design changes and risk files? That's the real regulatory clock.

#QualityManagement #DesignControl #RiskManagement

ASQ CCQM beginners: memorizing quality terms is only one part of preparation. Connecting concepts with construction scenarios, requirements, and practical decisions can make study more application-focused.

www.processexam.com/blog/one-asq...

#ASQ #CCQM #QualityManagement

if your endotoxin NCR triggered this recall, did it auto-link to supplier qualification, the, and ISO 14971, or did someone copy-paste between spreadsheets?
api.fda.gov/device/enforcement.json?search=reca…

#SupplierQuality #QualityManagement #CAPA

Governance in the Quality Management agent is now generally available: Governance in Dynamics 365 Customer Service helps organizations evaluate outbound emails and attachments against business-defined policies before delivery, reducing… @MSFTDynamics365 #Governance #QualityManagement #Dynamics365

€3,499/yr for uncapped users, priced by capability not headcount, what happens when eQMS is built for audit day, not procurement theatre.

#DocumentControl #AuditReady #QualityManagement

We see 142k imprecise readings. Whose design V&V cut a corner?

#CAPA #QualityManagement #DesignControl

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