LIMS · ELN · Analytics · AI
LIMS
Solutions built for every GMP quality control process
A purpose-built Laboratory Information Management System designed to match every quality control process — from raw material testing, in-process and finished product release testing, through to stability studies. Turn lab data into support for quality decision making.
Add contamination control — environmental monitoring and cleaning validation — for a fully integrated paperless quality system.
Capabilities
Everything a GMP QC lab needs in one system
Data integrity by design
ALCOA+ audit trails, electronic signatures and role-based access built to 21 CFR Part 11 and EU GMP Annex 11 — not bolted on.
Stability & shelf-life
ICH Q1 protocol design, automated pull-point scheduling and regression-based shelf-life estimation in one module.
Integrated instruments
Direct interfacing with HPLC, GC, balances, NIR, plate readers and pH meters. Results land in the record without transcription.
Built-in ELN
Method execution and analyst worksheets live inside the LIMS — no second vendor, no second validation package.
Rapid deployment
Out-of-the-box configuration covers ~95% of typical pharma URS. Live in weeks, not the 12–18 months generic LIMS demands.
Statistical trending
Control charts, capability indices and OOT/OOS detection across batches, sites and time — feeding APR/PQR directly.
Inspection-ready reports
Certificates of analysis, trend packs and audit responses generated from live data, formatted for regulators.
Lab workload manager
See analyst capacity, instrument availability and test backlog before the bottleneck becomes a deviation.
Integrated, process-specific solutions
One specification, followed from raw material to shelf life
Most LIMS platforms make you build your QC process. Nova-LIMS ships with it — three purpose-built modules sharing one specification library, one sample record and one audit trail.
Qualify incoming raw materials
Test and release raw materials, excipients and packaging before they reach production — with the supplier context that generic LIMS treats as an afterthought.
- Supplier and manufacturer qualification tracking
- Skip-lot testing rules and reduced-testing programs
- Full genealogy from lot received to product released
- Quarantine, sampling plans and COA reconciliation
Test in-process and finished product
In-process testing covers the bulk drug product before it is packaged; finished product testing covers it in its final packaging. Both run against the same specification library used upstream, so a spec change propagates instead of drifting.
- In-process testing of bulk product against release specifications
- Finished product testing in final packaged configuration
- Batch release workflow with electronic sign-off
- Automatic OOS / OOT flagging with investigation link
Track stability over time
Manage long-term, intermediate and accelerated studies to ICH Q1 — with results flowing back into the same lab record as the raw material and product data.
- Protocol design, chamber and pull-point management
- Automated time-point scheduling and overdue alerts
- Regression analysis and shelf-life estimation
- Trending across batches, conditions and packaging
Paperless by default
ELN + your equipment, built into LIMS
Nova-LIMS includes an electronic lab notebook (ELN) and the instrument interfaces in the same validated system.
- Analysts execute methods on screen — no worksheets to transcribe or reconcile
- Instrument results captured directly, eliminating transcription-errors
- Real-time barcode entry for samples, reagents and standards
- Calibration and PM status enforced at point of use — out of calibration instruments can’t generate a result
- One audit trail across LIMS, ELN and instrument data
What replacing paper actually removes
- Manual transcription steps per batch
- → 0
- Second validation package for ELN
- Not required
- Data review time
- Review-by-exception
- Audit trail location
- Single system
- Spec source of truth
- One library, all stages
Why pharma labs choose Novatek
Vertical software, not a configurable platform
Extend the system
Add contamination control for an integrated quality solution
Pair Nova-LIMS with environmental monitoring and cleaning validation and your viable/non-viable EM data, MAC calculations, worst case product evaluations and product testing all in one system, with one audit trail, under a compliant Annex 1 contamination control strategy.
Common questions
Pharmaceutical LIMS: frequently asked questions
A pharmaceutical LIMS is software that manages the full QC testing lifecycle in a GMP environment — sample login, specification management, test execution, result capture, review and batch release — under 21 CFR Part 11 controls. Unlike a general-purpose LIMS, a pharma LIMS ships with GMP workflows such as stability studies, OOS handling and release traceability already built.
A general-purpose LIMS is a configurable platform: the regulated workflows are yours to build and validate. A GMP LIMS ships with them. That difference shows up as implementation time, validation effort and audit risk — a generic platform typically requires 12–18 months of configuration before a pharma lab can run its first release test.
Yes. Nova-LIMS provides secure user access controls, time-stamped audit trails, electronic signatures and record-retention controls meeting 21 CFR Part 11 and EU GMP Annex 11, and is supplied with validation documentation (IQ/OQ/PQ templates) to support your qualification.
Nova-LIMS deployments are measured in weeks because roughly 95% of typical pharmaceutical user requirements are met by the out-of-the-box configuration. Scope, number of sites, instrument interfaces and legacy data migration drive the remainder.
Yes. The ELN is part of Nova-LIMS rather than a separately licensed product, so method execution and analyst worksheets share one database, one audit trail and one validation package with the LIMS.
Yes. Nova-LIMS supports bidirectional integration with ERP systems including SAP for material status and batch release, and connects natively to Novatek’s QMS, environmental monitoring, cleaning validation and calibration modules within the same suite.
Nova-LIMS interfaces directly with common QC instrumentation — HPLC and GC chromatography data systems, analytical balances, pH meters, NIR spectrometers, dissolution apparatus and plate readers — capturing both results and calibration data without manual transcription.
Yes. Nova-Stability manages long-term, intermediate and accelerated studies under the ICH Q1 guidelines, including protocol design, chamber and pull-point scheduling, time-point alerts, regression analysis and shelf-life estimation (ICH Q1E) — with results held in the same record as raw material and finished product testing.
Related solutions
Works with the rest of the Novatek quality suite
Environmental monitoring, cleaning validation and Annex 1 contamination control strategy in one connected suite.
Contamination control software →Deviations, CAPA, change control and document control connected to lab results.
Pharmaceutical QMS software →Calibration and maintenance, controlled inventory and other focused tools for daily lab and quality operations.
Quality & lab software solutions →See Nova-LIMS running your process
A walkthrough using your material types, your specifications and your release workflow — not a generic demo script.