The W3141 is the 21 CFR Part 11 compliant variant of the Accuris balance digital-data-export accessory kit — bundles the RS232-to-USB converter, cable, and the Accuris iWeight PRO software with electronic records / electronic signatures (ER/ES) compliance for regulated environments. The PRO software provides the audit trail, user-access control, and tamper-evident record-keeping required by 21 CFR Part 11 for pharmaceutical QC, GMP-compliant workflows, GLP-regulated laboratories, and validated systems in regulated industries.
Key Specifications
| SKU | W3141 |
| Type | Communication kit + iWeight PRO (21 CFR Part 11) software for regulated balance data export |
| Compatible balances | Accuris DX and TX balance series |
| Hardware included | RS232-to-USB converter + connecting cable |
| Software included | iWeight PRO — 21 CFR Part 11 compliant |
| Regulatory compliance | 21 CFR Part 11 (FDA Electronic Records / Electronic Signatures rule) |
| Compliance functions | Audit trail, user-access control, electronic signatures, tamper-evident records |
| PC connection path | Balance RS232 → RS232-to-USB converter → PC USB port |
| List price | $495 |
Datasheet detail note (FQ-014): Specific 21 CFR Part 11 audit-trail implementation details, user-management interface, system-validation package availability (IQ / OQ / PQ documentation), and OS compatibility are not stated in the available brochure-extract corpus and are intentionally not stated here rather than guessed. Confirm full iWeight PRO compliance documentation at quote with Accuris.
What 21 CFR Part 11 Compliance Means
21 CFR Part 11 is the FDA regulation governing electronic records and electronic signatures in regulated industries (pharmaceuticals, medical devices, biotech, cell-therapy manufacturing). For a balance-data-collection workflow to be 21 CFR Part 11 compliant, the software must support:
- Audit trail. Every data event (mass reading recorded, record edited, user login, configuration change) is logged with timestamp, user ID, and event description. The audit trail is read-only and preserved for the record-retention period.
- User-access control. Each user has a unique account with role-based permissions; passwords meet defined complexity requirements; account-lockout and session-timeout controls are enforced.
- Electronic signatures. Critical actions (record approval, batch release) require the user to authenticate again with a unique electronic signature that is bound to the record.
- Tamper-evident records. Records cannot be silently edited or deleted; any change is logged in the audit trail and the original value is retained alongside the new value.
- System validation. The end-user organization is responsible for IQ / OQ / PQ validation documentation; vendor-provided validation packages support that effort.
The W3141 iWeight PRO software is the regulated-tier sister to the W3140 base iWeight kit — same hardware (RS232-to-USB converter + cable), upgraded software for compliance.
W3141 vs W3140 — When to Pick Each
| Variant | Software | 21 CFR Part 11 | List price | Workflow context |
| W3140 | iWeight (base) | No | $250 | Research, teaching, non-regulated QC, in-process R&D |
| W3141 (this product) | iWeight PRO | Yes | $495 | Pharma QC, GMP manufacturing, GLP-regulated lab, FDA-regulated industries |
The $245 price differential ($495 vs $250) is the regulated-software premium — pick the W3141 when the workflow operates under 21 CFR Part 11 (or under a different regulatory framework that mandates the same audit-trail / electronic-signature / tamper-evident-records compliance functions). For research, teaching, and non-regulated workflows, the W3140 base kit delivers the same data-collection / statistics / graphing functions without the regulated-software cost.
When to Order This SKU
Order the W3141 when:
- Pharmaceutical QC weighing in a GMP environment — drug-substance and excipient weighing where 21 CFR Part 11 compliance is the workflow mandate
- GLP-regulated laboratory — non-clinical safety studies, environmental fate studies, residue studies, and other GLP-regulated weighing workflows
- Medical-device manufacturing — device-component weighing in a 21 CFR Part 820 quality system that maintains 21 CFR Part 11 compliance for electronic records
- Cell and gene therapy manufacturing — balance-data records as part of the GMP batch record where ER/ES compliance is required
- Replacement of legacy paper-based GMP weighing — labs migrating from paper-only records to electronic records as part of a digital-transformation initiative
Ordering & Configuration
Validation documentation. Confirm at quote whether vendor-provided IQ / OQ / PQ validation documentation is available with the iWeight PRO software, and how it pairs with the lab's existing system-validation framework.
User management. Confirm at quote the iWeight PRO user-account capacity, password-policy configuration options, and integration (if any) with enterprise identity systems.
Hardware + driver path. Same RS232-to-USB converter + cable as the W3140 — confirm OS compatibility for the regulated PC environment (typically locked-down validated Windows workstations in pharma QC).
Confirm at quote: balance model (DX / TX series confirmation), regulatory framework (21 CFR Part 11, GLP, GMP, ICH, equivalent), validation-documentation availability (IQ / OQ / PQ), licensing model, and lead time.
Warranty: Per Accuris standard accessory and regulated-software-license terms — confirm at quote.
Accuris balance accessory family:
- W3120 — Compact anti-static ionizer
- W3130 — Serial printer (RS232) for Dx / Tx analytical balances
- W3140 — Communication kit + iWeight (base) software — non-regulated workflows
- W3141 (this product) — Communication kit + iWeight PRO (21 CFR Part 11 compliant)
- W3300-TP — Thermal printer for broader balance compatibility
Pick the W3141 when 21 CFR Part 11 compliance is a workflow mandate; pick the W3140 base kit when it is not.
