Quality management
Control documents. Conduct audits. Close actions.
LabNote.Light connects document control, audit programmes, deviations and CAPA. Revisions, reviews, owners and due dates remain traceable on the records they belong to.
- Signed releases and acknowledgements
- Link findings to deviations and CAPA
Workflow
From released document to verified action
- 01
Control the document
Draft, review, signed release, distribution and acknowledgement in one version history.
- 02
Plan the audit
Set topics, timing and auditors in the programme; build checklists from templates.
- 03
Handle the finding
Record result and evidence on the checkpoint and create a linked deviation where needed.
- 04
Verify effectiveness
Document root cause and action plan, set a verification date and close the CAPA with a signature.
Document control
Each revision retains its review and release status
Drafts are maintained in the editor or as file references. Once submitted, the draft is frozen; review, signed release, distribution and acknowledgements are recorded on the version.
- Document register and revisions
- Document number, type, revision, status, validity and next review in a filterable register.
- Review, release and distribution
- Submit drafts for review, release them with a second person’s signature and assign roles or individuals.
- Acknowledgements and training
- Track pending acknowledgements per version and show linked training-plan items on the document.
- Periodic document review
- Filter due and overdue reviews; record and sign the outcome as unchanged, revision required or withdraw.
Audit planning and execution
Checkpoints, evidence and findings stay together
Audit programmes organise topics, periods and auditors. Each audit checkpoint records its result, note and evidence. A finding can continue directly as a linked deviation or risk.
CAPA
Handle root cause, action and effectiveness separately
A CAPA references its source and records priority, responsible person and due date. Moving to verification requires a defined effectiveness check and date; closure is signed.
The effectiveness check is a required verification plan with a date and closure approval, not a separate multi-stage approval process.
Full QM scope
Further quality-management areas
Documents, audits and CAPA form the core. Further quality records use the same people, deadlines and links.
- Audit programmes and addenda
- Approve multi-year programmes with topics, target months and auditors. Later addenda are reviewed separately.
- Internal and external audits
- Conduct internal audits with checklists and document external audits with source, report and findings.
- Deviations and complaints
- Record nonconforming work or complaints, assess them, assign owners and due dates, and close them separately.
- Corrective and preventive actions
- Manage CAPA with source, priority, root cause, action plan, responsibility, due date and effectiveness check.
- Risks and opportunities
- Assess likelihood and impact, assign treatments and repeat the assessment after treatment.
- Authorisations and training matrix
- Grant time-limited authorisations and compare qualifications, training and open requirements by person.
- Certificates and scope
- Manage certificates and scope documents with validity periods and expiry indicators.
- Suppliers and subcontractors
- Evaluate suppliers, calibration providers and subcontractors and document their approval status.
- Confidentiality and impartiality
- Manage declarations, agreements, conflicts of interest and acknowledgements as dedicated quality records.
- Quality objectives and management review
- Track objectives with progress and document management-review inputs, decisions and actions.
Common questions
Is LabNote.Light certified to ISO/IEC 17025 or ISO 9001?
No. LabNote.Light supports quality-management workflows and records. The organisation or laboratory is certified or accredited, not the software.
Can an author release their own document?
No. Releasing a document version requires a second authorised person and an electronic signature. The previous revision remains in version history.
What is recorded in a periodic document review?
The reviewer selects unchanged, revision required or withdraw, adds a note where needed and signs the review. Previous reviews remain visible on the document.
How are audit findings followed up?
The result, note and evidence are recorded on the checkpoint. A linked deviation or risk can be created from a nonconformity; CAPA retains its source as a reference.
When can a CAPA be closed?
Root-cause analysis and an action plan are required during processing. The effectiveness method and date are set before verification. Closure requires an authorised person and an electronic signature.
Can external auditors work directly in the system?
External audits can be documented with source, dates, report and findings. A dedicated external-auditor portal is not currently part of this workflow.