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1factory offers a manufacturing QMS for document control, training, audit readiness, and quality-event workflows.
Verified
| Controlled document revision history | 1factory documents authoring, redlines, and document versioning. |
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| Controlled document approval workflow | 1factory documents approval workflows for controlled documents. |
| Electronic signatures | 1factory lists eSignature as a 21 CFR Part 11 option. |
| Training and competency records | 1factory lists automated training assignments by job or role and tracks completion. |
| CAPA workflow | 1factory lists corrective and preventive actions with configurable workflows. |
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| Audit management | 1factory lists audit management in its QMS. |
| ISO 9001 focus or templates | 1factory names ISO 9001 among the standards for which its manufacturing QMS supports compliance. |
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| Vendor-stated manufacturing positioning | The vendor positions its QMS for manufacturing. |
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| Mobile quality inspections | Not documented |
| Nonconformance workflow | 1factory lists nonconformance management with configurable workflows. |
| Supplier quality | 1factory lists supplier qualification and certification. |
| Medical-device standards focus | 1factory names ISO 13485 among the standards for which its manufacturing QMS supports compliance. |
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| 21 CFR Part 11 support statement | Validated sign-in is identified as 21 CFR Part 11 compliant. |
1factory offers a manufacturing QMS for document control, training, audit readiness, and quality-event workflows.
1factory names ISO 13485 among standards supported by its manufacturing QMS. Published entry pricing: $20 per QMS user per month, with a 10-user minimum and annual billing.
