ISO/IEC 17025 – Laboratory Competence & Data Integrity with V5

V5 from SG Systems Global operationalizes ISO/IEC 17025 in real laboratory work. No slide decks, no after-the-fact “paper fixes.” V5 hard-gates the steps that generate data, captures attributable electronic records with sealed audit trails, and ties core quality processes—training, document control, deviations, CAPA, and change management—directly to sample testing and release. The backbone is a tight connection between execution on the floor, governed documentation, and custody-aware warehousing. The outcome: accreditation that stands up to scrutiny without slowing the bench.

Labs in regulated industries already live with predicate rules and data-integrity expectations. Pharmaceutical manufacturers use V5 to protect batch release decisions. Medical device organizations rely on it for calibration interlocks and training gates. Nutraceutical and supplement producers align it with Part 111 expectations. Food, cosmetics, ag-chem, and plastics labs use the same enforcement model for custody, labeling, and COA integrity. Electronic signatures meet the requirements most auditors look for under Part 11 and EU Annex 11, while records remain attributable, legible, contemporaneous, original, and accurate (ALCOA+).

“ISO/IEC 17025 gave us the expectations. V5 made them unavoidable—competence, calibration, custody, and reporting are enforced in the act of testing, not patched later.”

— Director of Quality, Global Contract Laboratory

The ISO/IEC 17025 Core: Competence Proven, Data Defended

ISO/IEC 17025 expects impartiality, technical competence, validated methods, controlled sampling/handling, measurement traceability, secure reporting, and a functioning management system. Most labs “say” they do this. V5 wires those expectations into daily execution so they’re measurable and reviewable—because they’re embedded in the systems that run your work.

1) Method & Instrument Control

In V5, every critical measurement is captured with context: who performed it, which instrument recorded it, the calibration status at time of use, the setpoint or limit, and the configured response when values drift. Think balances and pH meters, chromatographs and spectrometers, environmental chambers, and inline sensors. The reading is logged against the sample and the batch with device identity and pass/fail logic. If a criterion fails, the system applies a hold and alerts QA—there’s no “we’ll reconcile later.”

• Calibration interlocks: Due/overdue and out-of-tolerance states block acquisition until resolved.
• Revision discipline: Only the current, effective method or SOP can be executed; superseded versions are not selectable.
• Uncertainty context: Contributors and qualifiers are recorded or linked to the instrument record for traceability.

2) Sample Identity, Custody & Handling

V5 treats the sample as a first-class, barcoded object with identity, chain-of-custody, storage conditions, FEFO rules, and status. Retains, splits, and composites inherit the same discipline. If a unit is in quarantine or beyond its stability window, it cannot be used. When material moves, the person, place, time, and reason are captured automatically. Before shipment, pre-dispatch checks verify that COAs, holds, and specs match what’s leaving the building.

• FEFO & storage enforcement: The right unit, from the right location, at the right time.
• Retains & composites: Independent custody and status tracked end-to-end.
• Scan-enforced actions: Wrong lot or location is blocked at the point of work.

3) Competence & Authorization at Time of Action

Competence is a runtime decision. V5 maps roles to methods and instruments; the system checks training completion and recency before any regulated step can proceed. Dual-witness or second-person checks are enforced where your procedures require them. During assessment, an inspector can jump from a result to the signer and see the signer’s competence status at the exact time of the action—no binders, no manual cross-referencing.

• Matrix enforcement: Role → competency → permission. If expired, access is denied.
• Read-and-acknowledge: When a method changes, affected staff must re-acknowledge before execution.
• Approver rules: QA and supervisory approvals follow the same competence gates.

4) Reporting, COAs & Review

Reporting is governed by controlled templates with locked calculations, explicit unit conversions, and required context. Drafts cannot be mistaken for finals because issuance requires the proper review chain. Visual assets (logos, footers, regulatory text) are versioned with the template to prevent “old header on new spec” failures. Review is by exception—green runs don’t waste hours.

• Uniform COAs: Standardized content, clear authorization states, and complete audit trails.
• Linked evidence: From certificate back to instrument and method in a few clicks.
• Batch & customer context: Reports reflect the right specification set every time.

Predicate Rules & Data Integrity—Why ALCOA+ Isn’t Optional

ISO/IEC 17025 does not replace predicate regulations; it organizes them. V5 enforces the details most labs are judged on during inspection. Audit trails are immutable and attributable. Electronic signatures meet the core expectations auditors check for under common electronic records guidance. Role-based access and session controls reduce the chance of casual edits. Training and equipment status are evaluated at the time of action—not on a monthly spreadsheet.

• Attributable & contemporaneous: Every action binds person, device, and time at the point of work.
• Original & enduring: Raw and transformed records are preserved with checksums.
• Accurate & complete: Required fields and ranges validated; missing context cannot pass.
• Available: Authorized retrieval is fast and permissioned—no shared-drive scavenger hunts.

Lifecycle Control: Method Development → Validation → Routine Use

ISO/IEC 17025 spans the entire method lifecycle. During development, you define parameters and establish evidence of control. Validation locks ranges, accuracy/precision studies, and robustness checks. In routine use, V5 ensures only the validated method revision runs within the approved range. When you transfer from R&D to QC or between sites, the package—steps, tolerances, label logic, device settings, and training—moves as a governed set, not tribal knowledge.

• Change management: Impact assessments list affected products, instruments, training, and documents.
• Enforced rollout: Effective dates and prerequisites block old versions at the bench.
• Linked verification: PQ/PV checks and sample challenges are tied to the change record.

Material Governance & Warehousing—Where Many Findings Start

Many data issues begin with materials: wrong lot, expired stock, mis-zoned allergens, or mislabeling at pack. V5 removes luck from the equation. Intake checks, supplier status, COA capture, quarantine holds, FEFO putaway, location zoning, and scan-enforced issue controls are designed for regulated operations. If a component is on hold, it cannot be issued. If a label version is not approved, it cannot be printed. If a pallet is not serialized to the order, it cannot ship.

• Supplier control: Approved vendors only; COA failures route to supplier CAPA.
• Allergen zoning: Segregation in storage and staged issue with scan checks at the line.
• Serialization: Pallets and cases matched to order/customer; shipping verification blocks mismatches.

Deviations, CAPA & Risk—Close the Loop with Evidence

Deviations raised during execution open linked quality events automatically. The originating step, operator, device, lot, and time are already known, so containment is immediate: holds in execution, quarantine in warehousing, and customer blocks where applicable. Root cause tools and tasking are integrated; effectiveness checks are scheduled up front. Trend views show recurrence by site, method, device, and person—so you can prove the fix stuck.

• Immediate containment: Holds and quarantines propagate the moment a deviation is logged.
• Risk-based priority: Severity and occurrence drive routing and due dates.
• Audit-ready: Every action (who/when/why) is sealed with e-signatures and reasons.

Management Review—Not a Backward-Looking PDF Pack

Leadership needs to know whether the lab is in control. V5 replaces static packs with live dashboards: deviation density, CAPA aging, audit-trail anomalies, first-pass yield, retest rates, training compliance by role/area, supplier defect trends, release lead times, and recall readiness metrics. When someone asks “where is the evidence?”, you drill from KPI to site, to product, to batch, to the exact record—including who signed, on which instrument, and under which method revision.

• KPI rollups: Cycle time, deviation density, CAPA closure, and trend breaks.
• Drill-downs: Site → line → product → batch → record.
• Exportable evidence: Assemble the exact records inspectors will request.

Deployment—Validated, Documented, and Scalable

Cloud or on-prem, single site or multi-site, V5 is deployed with validation in mind. You receive configuration specs, test evidence, and IQ/OQ-style documentation to support your validation strategy (GAMP-aligned). Integration links your ERP, equipment, labelers, printers, scanners, and plant data sources so the lab record reflects reality without re-typing. Expansion into adjacent lines or sites reuses the same enforcement model with localizations handled as controlled changes.

• Validated workflows: Documentation packs aligned to your VMP and risk profile.
• System integrations: Orders, lots, methods, and results flow automatically between systems.
• Security & SSO: Role-based permissions and single sign-on for governance and IT.

“We didn’t need more reports. We needed enforced behavior. V5 turned our ISO/IEC 17025 program into the way the lab runs—competence and integrity as default settings.”

— Head of QC, EU Sterile Facility

What Inspectors Will See with V5

• Instant genealogy: Forward/backward trace with retains and rework paths.
• Proved controls: Instrument checks, sample custody, labeling governance, sanitation tasks—signed and time-stamped.
• Calibration & training at time-of-use: Proof that qualified people used qualified equipment.
• CAPA effectiveness: Trend reductions, recurrence checks, and linked change records.
• Document control: Effective SOPs and templates with approval signatures and revision history.

Modules That Power ISO/IEC 17025 in Practice

• Execution: Enforced steps, device checks, timers, witnesses, and e-signatures for test activities.
• Quality: Deviations to CAPA, training matrix, document control, change management, internal audits.
• Warehouse: Supplier status, intake inspections, FEFO/expiry, zoning, quarantine, serialization, and ship verification.
• Integration: ERP and equipment links so methods, lots, and results move without manual re-entry.

Bottom line: ISO/IEC 17025 is not a certificate; it’s a way of working. V5 bakes that discipline into your laboratory—so you don’t “prepare for audits,” you run to standard and let the system prove it. That’s competent. That’s consistent. That’s compliant.