Greenlight Guru eQMS is quality management software for medical device companies.
Greenlight Guru names ISO 13485, FDA QMSR, ISO 14971 and IEC 62304 in its medical-device quality scope. Published entry pricing: $12,000 per year.
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Greenlight Guru eQMS is quality management software for medical device companies.
Verified
| Controlled document revision history | Greenlight Guru describes document control for keeping the current version in use. |
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| Controlled document approval workflow | Greenlight Guru routes document approvals. |
| Electronic signatures | Greenlight Guru states that document control captures Part 11 electronic signatures. |
| Training and competency records | Greenlight Guru includes training management. |
| CAPA workflow | Greenlight Guru includes CAPA workflows. |
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| Audit management | Greenlight Guru includes audit management. |
| Vendor-stated manufacturing positioning | Not documented |
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| Mobile quality inspections | Not documented |
| Nonconformance workflow | Greenlight Guru includes nonconformance workflows. |
| Supplier quality | Greenlight Guru includes supplier management. |
| Medical-device standards focus | Greenlight Guru lists ISO 13485, FDA QMSR, ISO 14971 and IEC 62304. |
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| 21 CFR Part 11 support statement | Greenlight Guru states that document control captures Part 11 electronic signatures. |
| Vendor-stated target company size | Greenlight Guru says its software and expert services are designed exclusively for medical device companies, from early stage to global scale. |
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| Published QMS price | Greenlight Guru publishes a starting annual price for eQMS packages. |
| Free plan | Not documented |
| Free trial | Not documented |
Greenlight Guru eQMS is quality management software for medical device companies.
Greenlight Guru names ISO 13485, FDA QMSR, ISO 14971 and IEC 62304 in its medical-device quality scope. Published entry pricing: $12,000 per year.