Quality management connected to laboratory operations
Control documents, track nonconformities, verify equipment and look up technical evidence in the same environment where your team performs the work. Features that support ISO/IEC 17025, with a clearly documented scope.
What changes when quality lives in the same system as operations
In many laboratories, documents, nonconformities and analytical control sit in separate files. With the QMS in the same environment as the LIMS, quality records are linked to samples, equipment and results. That makes them easier to look up and cuts the rework of gathering information.
Records linked to operations.
Nonconformities, documents, calibrations and control charts live in the same system where the sample is received and the report is issued.
Searchable history.
Every document has a version, every calibration has a certificate and relevant changes are recorded with author and date.
Organized evidence.
Look up records and history on screen and prepare evidence according to the procedures and requirements that apply to your laboratory.
Quality and traceability features aligned with ISO/IEC 17025 routines
QMS areas
Each area has a page with what the system does today, its current limits and frequently asked questions.
Document control with versions, approval and read confirmation
Keep the master list with standardized codes, controlled versions and an approval workflow. When you publish a new revision, the previous one becomes obsolete and its controlled copies are recalled. Distribution and read confirmation are recorded with date and name.
See the areaNonconformities with cause analysis and effectiveness review
Log the occurrence, analyze the cause, set the action plan and check effectiveness before closing. The effectiveness review requires evidence. If the action did not work, the record can go back to the action plan.
See the areaAnalytical quality control with rules and control charts
Set up control types, frequency and rules per method. Check control charts and evaluate results according to the enabled rules and the criteria defined by the laboratory. The workflow can help identify deviations before release, depending on how the system is set up.
See the areaEquipment with calibration, maintenance and usage control
Register equipment with its life cycle, calibration with certificate and uncertainty, and maintenance. The system warns about calibration due dates. Using expired or failed equipment triggers an alert or a block, depending on the setup.
See the areaSupplier evaluation and complaint handling
Evaluate suppliers on every purchase received, track the supplier quality index (IQF) and keep the evaluation history. Customer complaints are handled in customer service, with a ticket number and response-time tracking.
See the areaData integrity and sample traceability
The system records who did what and when for changes to the main records and results, plus system logins. Corrections record the change and keep the previous value. These records support the ALCOA+ principles adopted by the laboratory.
See the areaControlled forms, built by your team
Build forms such as a balance check, a cleaning checklist or a sample inspection right on screen. Choose the fields, set approval rules and publish. A published form is locked, and changes create a new version.
See the areaISO/IEC 17025 requirements map
See, clause by clause, what the system offers today, the status of each feature and what remains the laboratory's responsibility. ISO/IEC 17025 accreditation is granted to the laboratory for the applicable scope, not to the software.
See the areaEvidence by task
See how some quality tasks look in the system. The screens are illustrative and use demo data.
Illustrative system screen. Demo data that does not represent client results.
Publish a new revision of a procedure
The revision goes through a recorded approval and is distributed to whoever needs to read it. Once it is published, the previous revision becomes obsolete and its controlled copies are recalled. Read confirmation is recorded with date and name.
See this flow in the demoIllustrative system screen. Demo data that does not represent client results.
Handle a nonconformity through to the effectiveness review
Cause analysis with Ishikawa or the 5 Whys, a 5W2H action plan, validation and implementation. The effectiveness review requires evidence before closing. If the action did not work, the record goes back to the action plan.
See this flow in the demoIllustrative system screen. Demo data that does not represent client results.
Track an instrument's calibration
The workflow shows the instrument's states and the 90, 60, 30 and 0-day alert ranges. Using expired or failed equipment triggers an alert or a block, depending on the setup. The default is to warn.
See this flow in the demoQuality control with rules and statistical monitoring
Check control charts and evaluate results according to the enabled rules and the criteria defined by the laboratory. The workflow can help identify deviations before release, depending on how the system is set up.
Six rules per run and the 7T trend on the dashboard
The system applies 6 rules when evaluating each run (1-2s as a warning, 1-3s, 2-2s, R-4s, 4-1s and 10x) and shows the 7T trend on the dashboard, with Levey-Jennings, CUSUM and EWMA charts. The action taken when a rule is violated is configured by the laboratory: warning, flagging the batch as blocked, logging a quality control nonconformity or reanalysis.
Technical decisions, such as acceptance criteria, decision rules, method validation and release of results, belong to the laboratory. The system records and organizes these decisions.
Illustrative system screen. Demo data that does not represent client results.
Check a parameter's control chart
The Levey-Jennings chart shows the 1s, 2s and 3s zones and the outcome of the rules evaluated in the run. The CUSUM and EWMA tabs help track small, persistent deviations.
See this flow in the demoCurrent features and limits
Status of each quality feature in the current version of the system, what exists today and what remains the laboratory's responsibility.
| Topic | Status | What exists today | Limit / laboratory responsibility |
|---|---|---|---|
| Document control | Available | Documents with versioning, approval, distribution, read confirmation, periodic review and online editing. | Document content, approvers and review intervals are defined by the laboratory. |
| Nonconforming work | Available | Nonconformity records with cause analysis, action plan and an effectiveness review step that requires evidence. | Assessing the impact, deciding to halt or release work and notifying the client are up to the laboratory. |
| Corrective actions | Available | Nonconformity with cause analysis, an action plan with deadlines and owners, and an effectiveness review that requires evidence. | Cause analysis and the decision on whether actions were effective are up to the laboratory. |
| Measurement uncertainty | In development | Records the uncertainty entered for the parameter, for the result and on the calibration certificate (value, unit and k factor). It also stores the value calculated by the laboratory's own method spreadsheet. | The system does not calculate combined or expanded uncertainty and does not build an uncertainty budget. Estimating uncertainty is the laboratory's responsibility; a dedicated calculation is in development. |
| Risks and opportunities | Available | Register of risks and opportunities with a configurable probability and impact matrix, heat map, periodic assessments and FMEA. High and critical risks require a treatment strategy and can open a nonconformity. | Identifying risks, setting the matrix criteria and evaluating the effectiveness of actions are the laboratory's responsibility. |
| Equipment and calibration | Depends on configuration | Equipment register with life cycle, calibration with certificate and uncertainty, maintenance and expiry alerts. Using expired or failed equipment triggers an alert or a block, depending on the setup. | The default is to warn. Blocking applies to equipment flagged as critical or when the laboratory turns on blocking mode. |
| Ensuring the validity of results | Available | Analytical quality control with configurable control types, Westgard rules and Levey-Jennings, CUSUM and EWMA charts. | The control plan, acceptance criteria and participation in proficiency testing are defined by the laboratory. The action on failure follows each rule's setup. |
| Internal audit | Available | Annual audit program, ISO/IEC 17025-based checklist, findings log and report. | Auditor competence and independence and checklist content are defined by the laboratory. |
ISO/IEC 17025 accreditation is granted to the laboratory for the applicable scope, not to the software.
The platform is a support tool. Demonstrating competence and meeting the standard are the laboratory's responsibilities.
Modules available according to the contracted scope.
Frequently asked questions
Is Gerencialab ISO/IEC 17025 accredited?
ISO/IEC 17025 accreditation is granted to the laboratory for the applicable scope, not to the software. The platform is a support tool. Demonstrating competence and meeting the standard are the laboratory's responsibilities. Gerencialab provides supporting features such as document control, nonconformities, analytical quality control, equipment and audit trail.
How does the system help with audit preparation?
Look up records and history on screen and prepare evidence according to the procedures and requirements that apply to your laboratory. Master list, nonconformities, control charts, calibrations and audit trail live in the same system.
Which Westgard rules does the system evaluate?
The system applies 6 rules when evaluating each run (1-2s as a warning, 1-3s, 2-2s, R-4s, 4-1s and 10x) and shows the 7T trend on the dashboard, with Levey-Jennings, CUSUM and EWMA charts. The action taken when a rule is violated is configured by the laboratory: warning, flagging the batch as blocked, logging a quality control nonconformity or reanalysis. The 6 rules are applied together: the laboratory does not select Westgard rules one by one. The laboratory defines the control plan and, for each control rule, the acceptance criterion (for example quantification limit, range, recovery, RPD, z-score or Westgard) and the frequency.
How does the system handle measurement uncertainty?
The system records the uncertainty entered for the parameter, the result and the calibration certificate, or the value calculated by the laboratory's method spreadsheet. The system does not calculate combined or expanded uncertainty; that calculation is in development.
Is there risk and opportunity management (clause 8.5)?
Yes. Risks and opportunities module with a configurable probability and impact matrix, heat map, assessments and FMEA. Risk identification and treatment actions are defined by the laboratory. High and critical risks require a treatment strategy and can be turned into a nonconformity.
Are the QMS and analytical quality control included?
Modules available according to the contracted scope. In the demo and in the proposal, we show what is included in your laboratory's scope.
Want to see these features with your scenario?
Discuss your workflow and arrange a free demo on WhatsApp.
Ask a question on WhatsAppWant to see the QMS with your laboratory's routine?
Free online demo, about 30 minutes long. Our team adapts the examples to your laboratory's routine.