Clause 4.1Impartiality
User access & security control
Role-based permissions and blind-sample options isolate analysts from commercial client records.
Compliance
The only NABL/ISO 17025 Ready LIMS.
Designed around ISO/IEC 17025, 21 CFR Part 11 and NABL, so data integrity, traceability and audit readiness aren't a separate project, they're how the system already works.
ISO/IEC 17025:2017
Accreditation, embedded into daily work
Technical competency, equipment calibration and method validation aren't checked before an audit, they're enforced on every sample, every day.
- Instruments are locked out automatically the moment calibration is overdue
- Testing always runs against the current, approved SOP version, never an outdated one
- Test methods can only be assigned to analysts who are certified for them
- Quality manuals and controlled documents stay version-locked in the DMS
21 CFR Part 11
Data integrity that holds up to scrutiny
Every digital record, system log and signature is built to the standard regulated environments require, not adapted afterward.
- Every action is logged automatically: who, what, when, and why
- Multi-level electronic signatures tied to a unique, verified user ID
- Role-based access, automatic logouts, and enforced password aging
- Encrypted databases with continuous, automated backup tracking
NABL
Audit-ready, before the assessor arrives
Accreditation records exist in the format an assessor expects, so audit prep stops being a scramble.
- NABL-format Certificates of Analysis with embedded QR verification
- Proficiency testing and inter-lab comparisons logged and plotted automatically
- Built-in measurement uncertainty calculators on every applicable result
- Faster response to audit observations, days instead of weeks
60%+
less audit preparation effort
The guarantee
The audit trail guarantee
Every sample login, result entry, modification, instrument calibration check, and final COA authorization writes an unalterable system log. Editing a result is never silent: it requires a mandatory reason code before the system will accept the change.
ISO 17025 : NABL compliance matrix
Every clause maps to a working module, not a policy document.
Sampleify is structured around the core clauses of ISO/IEC 17025:2017. Here's exactly which module satisfies which clause, and how the control runs automatically.
| Clause | Requirement | Sampleify module | Automated control |
|---|---|---|---|
| 4.1 | Impartiality | User access & security control | Role-based permissions and blind-sample options isolate analysts from commercial client records. |
| 4.2 | Confidentiality | Document Management System (DMS) | Encrypted client data and strict sharing controls prevent unauthorized access to test reports. |
| 6.2 | Personnel competency | Competency & training matrix | Blocks analysts from assignments or result entry on tests where their qualification has lapsed. |
| 6.3 | Facilities & environment | Environmental data logging | Auto-captures temperature and humidity, and flags testing if conditions fall out of spec. |
| 6.4 | Equipment & calibration | Instrument calibration & maintenance | Tracks usage and calibration schedules; overdue instruments are locked out automatically. |
| 6.5 | Metrological traceability | Reagent & standard inventory | Full lot-number traceability for CRMs, volumetric solutions, and working standards. |
| 7.1 | Review of contracts | Client job & commercial billing | Captures specs, method feasibility, and pricing before a sample is ever processed. |
| 7.2 | Selection of methods | SOP document management | Version-controlled method repository enforces current, validated parameter limits. |
| 7.4 | Handling test items | Sample management & barcoding | Chain-of-custody tracking, barcode generation, rack mapping, and retention scheduling. |
| 7.7 | Validity of results (IQC) | Internal Quality Control (IQC) | Auto-inserts duplicates, blind samples and spikes, with Levey-Jennings control charts. |
| 7.8 | Reporting results | Automated COA engine | Generates NABL-format certificates with dynamic QR codes, signatures, and uncertainty metrics. |
| 7.9 | Complaints | Customer complaints & feedback | Centralized logging, root-cause tracking, CAPA assignment, and SLA monitoring. |
| 7.10 | Nonconforming work | OOS / OOT / CAPA investigation | Structured out-of-spec workflows, impact analysis, and CAPA execution tracking. |
| 7.11 | Control of data | Core LIMS architecture | 21 CFR Part 11 audit trails, encrypted databases, and continuous backups by default. |
| 8.8 | Internal audits | Internal audit management | Schedules audit cycles, logs findings, assigns owners, and tracks completion. |
| 8.9 | Management review | Management Review Meetings (MRM) | Records MRM schedules, agendas, policy updates, and historical decisions. |
Clause 4.2Confidentiality
Document Management System (DMS)
Encrypted client data and strict sharing controls prevent unauthorized access to test reports.
Clause 6.2Personnel competency
Competency & training matrix
Blocks analysts from assignments or result entry on tests where their qualification has lapsed.
Clause 6.3Facilities & environment
Environmental data logging
Auto-captures temperature and humidity, and flags testing if conditions fall out of spec.
Clause 6.4Equipment & calibration
Instrument calibration & maintenance
Tracks usage and calibration schedules; overdue instruments are locked out automatically.
Clause 6.5Metrological traceability
Reagent & standard inventory
Full lot-number traceability for CRMs, volumetric solutions, and working standards.
Clause 7.1Review of contracts
Client job & commercial billing
Captures specs, method feasibility, and pricing before a sample is ever processed.
Clause 7.2Selection of methods
SOP document management
Version-controlled method repository enforces current, validated parameter limits.
Clause 7.4Handling test items
Sample management & barcoding
Chain-of-custody tracking, barcode generation, rack mapping, and retention scheduling.
Clause 7.7Validity of results (IQC)
Internal Quality Control (IQC)
Auto-inserts duplicates, blind samples and spikes, with Levey-Jennings control charts.
Clause 7.8Reporting results
Automated COA engine
Generates NABL-format certificates with dynamic QR codes, signatures, and uncertainty metrics.
Clause 7.9Complaints
Customer complaints & feedback
Centralized logging, root-cause tracking, CAPA assignment, and SLA monitoring.
Clause 7.10Nonconforming work
OOS / OOT / CAPA investigation
Structured out-of-spec workflows, impact analysis, and CAPA execution tracking.
Clause 7.11Control of data
Core LIMS architecture
21 CFR Part 11 audit trails, encrypted databases, and continuous backups by default.
Clause 8.8Internal audits
Internal audit management
Schedules audit cycles, logs findings, assigns owners, and tracks completion.
Clause 8.9Management review
Management Review Meetings (MRM)
Records MRM schedules, agendas, policy updates, and historical decisions.
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