Analysis and Method Management in LIMS

The fundamental requirement for producing accurate, repeatable, and verifiable results in laboratories is the standardized, versioned, traceable, and validated management of analytical methods. LIMS/LBYS Analysis and Method Management integrates the entire lifecycle, from method development and validation to routine use and change control, on a single platform. You can review the details of the solution on the official website: Analysis and Method Management.

Why Should the Method Lifecycle Be Digital?

Accurate Information from a Single Source

The SOP, calculation rules, acceptance criteria, and checklists are managed from a single point of validity; versions do not overlap.

Reduced Risk of Errors

Automatic field validations, unit alignment, and mandatory step approvals minimize application errors.

Auditability

The audit trail, along with e-signatures and timestamps, answers all the questions of who did what and when.

End-to-End Analysis & Method Management

Stage Explanation Critical Outputs

1) Method Development The method's objective, scope, matrix, and target analyte(s) are defined; preliminary experiments and optimization are performed. Preliminary protocol, parameter ranges, calculation formulas, device/column selection.

2) Validation Design An ISO/IEC 17025 compliant validation plan is created; parameters such as accuracy, repeatability, and specificity are determined. Validation plan, sample sizes, acceptance criteria, statistical methods.

3) Performing Validation Work lists and control samples are generated automatically; results are monitored in real time. LOD/LOQ, linear range, R², CV%, recovery, robustness reports.

4) Approval & Publication It is approved by the responsible party with an e-signature; a version number is assigned and it is published. Approved SOP, template reports, training requirements.

5) Routine Use Work lists, calculations, acceptance criteria, and QC diagrams are applied automatically. QC charts (e.g., Levey–Jennings), interim reports, OOS/OOT capture.

6) Change Check Method parameter/SOP updates are managed via a controlled flow; partial re-validation is triggered when necessary. Version change summary, impact analysis, training completion records.

7) Retirement/Archives Methods that are no longer in use are archived; active processes are safely upgraded to the new version. Archive plan, traceable version history, rollback capability.

Validation Parameters and Monitoring

LIMS tracks accuracy, repeatability/intermediate precision, specificity/selectivity, LOD/LOQ, linearity, range, robustness, and ruggedness criteria via the method card. Relevant data can be automatically retrieved from instrument connections; field validation and unit control are provided for manual entries. For results outside the acceptance criteria, the system immediately initiates OOS/OOT workflows; root cause analysis and rerun steps are recorded.

Calculations, Curves, and Acceptance Criteria

• Calibration Curves: Automated evaluation of multiple point regression, weighted regression, and R² thresholds.
• Formulas: Dilution factor, recovery percentage, uncertainty components, and rounding rules are released along with the method.
• Acceptance Windows: QC upper/lower control limits and system compliance criteria (USP/EP, etc.) are stored on a method basis.

Device & Instrumentation Integration

Automatic data transfer from instruments reduces errors caused by manual input, strengthens data integrity, and shortens cycle time. The method card prevents the use of incorrect instruments or expired consumables by associating instrument calibration/validation statuses, column/reagent lot information, and maintenance plans. The system automatically generates alerts in case of non-conformity.

SOP and Training Management

Each method version is mapped to a SOP (Standard Operating Procedure). Training assignments are automatically made for relevant personnel in updated versions, and success is tracked. Users who do not complete the training are not authorized to implement the method; this is ensured through role-based rules.

Data Integrity, E-Signature, and Audit Trail

LIMS generates evidence that data is attributable, legible, contemporary, original, and accurate, in accordance with ALCOA+ principles. All critical actions are recorded with an audit trail; e-signatures and timestamps can be mandated for process approvals. This facilitates compliance with ISO/IEC 17025 and GxP expectations.

Reporting and Indicators

Validation Reports

Parameter-based result tables, graphs, and automated reports summarizing acceptance/rejection decisions.

Performance Indicators

Cycle time, rerun rate, OOS/OOT numbers, and nonconformity trends by method.

Integration and Education

Training completion rates, signature/version matching, device compatibility status.

Change Control and Versioning

Change requests are transformed into version upgrades by going through impact analysis, risk assessment, and approval steps. Partial/re-validation is automatically initiated if necessary. Older versions are archived, and traceability is maintained.

Operational and Strategic Benefits

• Standardization: Unity of application, formula, and acceptance criteria across the organization.
• Speed: Shorter cycle times through automation in worklists, calculations, and reporting.
• Quality: Continuous improvement through early warnings of OOS/OOT, QC visualizations, and audit trails.
• Compliance: Documentation, e-signature, and version control compliant with ISO/IEC 17025 and GxP requirements.
• Scalability: Rapid deployment of new methods, fast rollout with structured templates.

Suggested Steps for a Quick Start

• Inventory active methods; transfer SOPs, formulas, and acceptance criteria to digital method cards.
• Define validation parameters and acceptance thresholds; correlate test data retrospectively.
• Prioritize device integration; mandate calibration/validation status checks.
• Clarify the change control flow and authorization matrix; implement e-signature steps.
• Prepare a training plan; enable automatic training assignments in new version releases.

You can find more details by visiting the solution page: Analysis and Method Management.