Raw Material Analyzer Software
Nova-RM is the raw material testing module of Nova-LIMS. It runs incoming material testing end to end — registration, supplier and manufacturer qualification, sampling plans, reduced and skip-lot testing, instrument acquisition, investigations, release and certificate of analysis — then trends and reports the result. Integrated with the finished product and stability modules on one platform, so genealogy from lot received to product released is recorded as work is done.
Raw Material Decisions Set the Ceiling on Product Quality
Every downstream release depends on what was accepted at receipt. Yet reduced-testing eligibility is often tracked in a spreadsheet, results are keyed in from instrument printouts, and supplier history sits apart from the test data. The cost shows up when someone has to analyze, trend and report on it — during an annual product review, a supplier investigation or an audit trail request.
The Complete Raw Material Testing Workflow
Generic LIMS platforms treat raw materials as a sample type and leave the material-specific work to configuration or a spreadsheet. Nova-RM connects all nine stages — from specification through instrument acquisition to trending and reporting — in one place.
What Changes When Raw Material Testing Runs in Nova-LIMS
Instruments feed results straight into the record — chromatography data systems, balances, titrators and more. No transcription step, and no transcription-error deviations.
Eligibility follows the material, supplier and manufacturer, and the system applies full or reduced testing. Skip-lot and parametric programs stay defensible because the rule lives in the system.
Tracked at the material level, so history is queryable: which lots failed, from which manufacturer, against which specification. The data a supplier qualification review needs and rarely has.
Raw material, in-process, finished product and stability run on one integrated platform, so genealogy from lot received to product released is a query rather than a reconstruction project.
Control charts, normal and Weibull distribution, cumulative sum OOT and ad-hoc KPI queries run on live data — so the people releasing product see the trend, not just the result.
Raw material work is planned alongside finished product, stability, environmental and utility monitoring and calibration — one view of analyst capacity and due dates for the whole laboratory.
Built for the Way Raw Material Testing Actually Runs
Direct interfacing with chromatography data systems, balances, titrators and other QC instrumentation, plus bidirectional SAP and ERP integration for material import and status. Results and auxiliary data — instrument, standard, solution — are acquired against the record, not keyed in.
Workflows by material type — raw materials, in-process, APIs, components, standards and solutions — with templates, user-defined field labels, retest and solution expiry notifications, and supplier and manufacturer tracking that drives automated reduced or full testing.
Version-controlled monographs and test matrices built from templates, multi-market specifications, and a formula builder whose calculations must be approved and validated before use. Dissolution profiling, impurity and multi-stage testing are automated rather than configured per lot.
Sampling plans calculated automatically, with barcodes for the initial bag, retention, departmental distribution and aliquots. Chain of custody is performed by scan, and inventory adjusts per department as samples move.
Replicates, retests, resamples and ad-hoc samples with automatic mean, standard deviation and variance. OOS by market and OOT raise notifications and link to investigations. Bulk review and approval with a jump to the audit trail, then release and certificate of analysis from live data.
Real-time trending by material, supplier, manufacturer and market. Process control charts, normal and Weibull distribution and cumulative sum OOT show whether the process is in a state of control, and an ad-hoc query tool builds the KPI and APR reports quality management actually asks for.
Built for Regulated Raw Material Testing
Compliance & Data Integrity
- Compliant with 21 CFR Part 11 and EU GMP Annex 11
- Developed to FDA, ICH, EU and other international guidelines
- Independent, non-modifiable audit trail
- Electronic signatures and multi-step approvals
- Flexible user levels and access rights
- cGMP and GLP aligned
Validation
- Validation gap analysis
- IQ/OQ documentation and execution support
- Optional PQ documentation and execution assistance
- Process mapping to align the system with your SOPs
- Role-based training so every user is ready on day one
Deployment & Fit
- Cloud or on-premise deployment
- Out-of-the-box configuration — far less build than a generic LIMS
- Built-in ELN, no second vendor or validation package
- SAP, ERP and MES integration
- Site-level data segregation with centralized administration
- Modular — take raw materials alone, or the full LIMS
Raw Material Testing Software: Common Questions
Raw material testing software manages the testing and release of incoming materials in a regulated manufacturing environment — registration, specification management, sampling, testing, investigation and release. Nova-RM performs this as a module of Nova-LIMS, so raw material results share a database with in-process, finished product and stability data.
It is a module of Nova-LIMS. Nova-LIMS is modular by design and built on a workload management framework with instrument interfacing; raw materials, finished products and stability can be taken individually or together, integrated on one platform with a shared specification library.
Because the processes differ. Raw material testing needs supplier and manufacturer tracking, skip-lot and parametric testing and reduced-testing programs. Finished product testing needs traceability back to the raw materials used and feeds the zero timepoint of stability. Separating them allows each to be feature-rich rather than generically configured.
Yes. Reduced or full testing is applied automatically based on the material, supplier and manufacturer, so skip-lot and parametric programs run from a rule held in the system rather than a spreadsheet maintained alongside it.
Real-time trending by material, supplier, manufacturer and market, with process control charts, normal and Weibull distribution and cumulative sum OOT to show whether the process is in a state of control. An ad-hoc query tool builds KPI and annual product review reports from live data.
Yes. Ingredients and APIs are linked at batch level, and because the raw material, finished product and stability modules are integrated on one platform, genealogy from lot received to product released is a report rather than a manual exercise.
Nova-LIMS interfaces directly with chromatography data systems, balances, titrators and other QC instrumentation so results are acquired rather than transcribed, and supports bidirectional SAP and ERP integration for material import and release status.
Nova-LIMS ships with pharmaceutical workflows already built, including the electronic lab notebook. Generic LIMS platforms are configurable frameworks in which those workflows are constructed and then validated — which is where most of the implementation time and validation effort in a LIMS project is spent.