For Medical-Device QA/RA Managers
Medical-device QA/RA Manager — traceable records behind every device.
You answer to your quality system and to regulators.
Production records, quality decisions and documents live in different systems.
Production steps, deviations, corrective actions and controlled documents are kept in one system with audit history.
Document changes reach the floor before people are ready.
Controlled documents carry revisions and signatures, and role-based access controls which kiosk actions people can use.
Tracing a lot back to what was used and who did the work takes too long.
Lots and traceability connect materials, production steps and signatures.
All problems V5 helps with4 in total
Production records, quality decisions and documents live in different systems.
Production steps, deviations, corrective actions and controlled documents are kept in one system with audit history.
Document changes reach the floor before people are ready.
Controlled documents carry revisions and signatures, and role-based access controls which kiosk actions people can use.
Tracing a lot back to what was used and who did the work takes too long.
Lots and traceability connect materials, production steps and signatures.
Supplier qualification is hard to show when asked.
Supplier qualification is kept with quality records, connected to purchasing and receiving.
A day as a Medical-Device QA/RA Manager with V5
Open V5 to review open deviations and corrective actions, check recent production records and their signatures, and trace a lot back to materials and operators when a question comes in.
Checks to run in your evaluation5 checks
- Which records make up your device history record, and which of them will V5 hold?
- Which records need electronic signatures, and who may sign?
- How do complaints, design controls and regulatory reporting connect to production records in your quality system today?
- How will you validate V5 for your intended use?
- V5 supports your own procedures and validation. The software does not by itself establish compliance, certification or a validated state.
Modules you will useQuality Management, Document control, Audits & CAPA, Supplier Quality
Quality Management
Deviations, corrective actions and quality review alongside production.
Document control
Controlled work instructions and specifications with electronic signing.
Audits & CAPA
Record findings and corrective actions under your approval workflow.
Supplier Quality
Supplier qualification connected to the records it affects.
eDHR
Device history records built from recorded production steps.
Common questions3 answers
- Does V5 make us compliant with 21 CFR 820 or ISO 13485?
- No software does that by itself. V5 provides records, audit history and electronic signing that support your quality system; compliance depends on your procedures, configuration and validation.
- Does V5 manage design controls and the design history file?
- V5 focuses on production, quality and controlled records. Talk to us about how your design-control tools and V5 would sit together.
- Can we keep our current design-control tool?
- You can keep your current design-control tool. V5 focuses on production, quality and controlled records; any data exchange or interface would need to be assessed for your specific tools and configuration.