ERP for the medical device industry
Agile ERP software to manage your medical data, R&D and quality assurance, and to follow production in a heavily regulated environment (ISO 13485, GMP).
- Traceability and DHR/eDHR
- Quality management (QA/QC)
- Security and 21 CFR Part 11
The medical manufacturing trades: what sets them apart
Manufacturers of medical devices (MedTech), implants or diagnostic equipment: you work in businesses held to exceptionally high requirements.
It is a highly specialised world that demands agility and rigour day in, day out. From R&D design through to distribution, by way of servicing your devices, every process must be fully controlled and documented.
Certifications — the ISO 13485 standard, CE marking and the MDR regulation — set the tempo of your value chain. Your information system must build compliance and quality assurance in natively.
Regulatory demands on an immense scale
From placing on the market (regulatory compliance such as FDA 21 CFR part 11) to after-sales service, regulatory obligations abound.
Impeccable tracking of batch traceability and serial numbers through Device History Records (DHR and eDHR) is critical. A human or documentary error can cost a delayed accreditation or a mass product recall.
With AVIA ERP, mandatory electronic signature, double-check validation and automatic blocking of non-conforming or out-of-date batches (expiry date, best-before date) keep your operations secure with complete peace of mind.
The advanced functions dedicated to the medical industry
- Traceability and DHR/eDHRComplete paperless electronic batch record, upstream and downstream. Device history record (DHR) validated in real time.
- Quality management (QA/QC)Integrated quality management system. Digitised incoming inspection and release checks, handling of non-conformances and CAPA (corrective and preventive actions).
- Security and 21 CFR Part 11Strong authentication, tamper-proof audit logs and electronic signatures at every key step, safeguarding the integrity of your health data.
- Cleanroom schedulingCross-referenced scheduling that accounts for staff approvals and for the strict environmental conditions (ISO 5, 7, 8).
- Purchasing complianceStrict approval of subcontractors and suppliers, with revision control at the point of purchase to block obsolete parts.
The direct benefits for your industrial company
A scalable solution built for reliability
The ERP makes your procedures dependable and removes manual re-entry, drastically cutting documentary errors (paperless).
Command of the product life cycle
With the eDHR built in, from R&D prototyping (PLM) through to through-life support, all product information is held in one place.
A more profitable organisation
By lightening the administrative load carried by quality assurance, you shorten your time to market and focus your teams on innovation.
Get a personalised demonstration of our ERP!
Request your demoThe industries AVIA ERP covers
Every industrial sector demands its own rigour. AVIA adapts to your regulatory constraints through focused domain modules.
Industrial diagnostic: forty-five minutes, one real process, a written summary.
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