In-Process & Finished Product Analyzer Software
Nova-FP is the in-process and finished product testing module of Nova-LIMS. In-process testing covers bulk product before packaging; finished product testing covers it in its final packaged form. Both run against the same specification library used for raw materials, with results acquired directly from instruments, traceability back to the materials that went in, and trending that supports the release decision.
Release Is a Decision, Not a Test Result
Releasing a batch means confirming every test against the right specification for the right market, checking no investigation is open, and showing where the materials came from. When specifications sit in one system, results are transcribed from instruments into another, and trending is rebuilt in a spreadsheet, release slows down and the evidence an inspector asks for is assembled after the fact.
The Complete Finished Product Testing Workflow
Nova-FP connects all nine stages of in-process and finished product testing against the same specification library used upstream — from setup through instrument acquisition to trending and reporting — so a specification change propagates rather than drifts.
What Changes When Product Testing Runs in Nova-LIMS
Chromatography data systems such as Empower, balances and other QC instrumentation feed results straight into the record. No transcription step, and no transcription-error deviations.
Multi-market specifications sit against the same product, so OOS is evaluated per market, the certificate of analysis is generated for the market being released to, and trending filters the same way.
Ingredients and APIs are linked at batch level. A batch resolves to the raw material lots it consumed, and a raw material investigation resolves to the batches at risk — without exporting anythin
Release data feeds the zero timepoint of the stability study rather than being re-entered, so the study begins from the same verified result the batch was released on.
Control charts, normal and Weibull distribution, cumulative sum OOT and ad-hoc KPI queries run on live data — the trending and investigation history an APR or PQR requires, available before release, not after.
Finished product work is planned alongside raw material, stability, environmental and utility monitoring and calibration, with analyst, verifier and approver assigned by test or by group.
Built for the Way Product Testing Actually Runs
Direct interfacing with chromatography data systems such as Empower, balances and other QC instrumentation, plus bidirectional SAP and ERP integration for product import and release status. Auxiliary data — instrument, standard, solution — is captured against the result automatically.
Workflows by product type with templates and user-defined field labels. Each batch logs samples, records date received and manufactured, links ingredients, APIs and attachments, sets a priority that drives due dates, and tracks expiry, retest and retention.
Version-controlled monographs and test matrices compatible with pooled, non-pooled and AQL sample types. Specifications by market generate market-specific certificates of analysis and trending, and the formula builder links multiple tests under approval and validation.
Bulk product testing before packaging and finished product testing in final packaged configuration, both against the same specification library. Dissolution profiling, impurity and multi-stage testing are automated rather than configured per batch.
Replicates, retests, resamples and ad-hoc samples with automatic mean, standard deviation and variance. OOS by market and OOT link to investigations. Bulk review and approval with a jump to the audit trail, then release, market selection and certificate of analysis from live data.
Real-time trending by product, batch 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 Product Release
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
- Audit trail review before final approval
- 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 finished products alone, or the full LIMS
Finished Product Testing Software: Common Questions
In-process testing covers the bulk drug product before it is packaged. Finished product testing covers the product in its final packaged configuration, and is the basis for batch release. Nova-FP runs both against the same specification library used for raw materials.
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.
Yes. Multiple specifications are held against the same product, OOS is evaluated per market, the certificate of analysis is generated for the market being released to, and results can be trended by market.
Release data feeds the zero timepoint of the stability study directly, so the study starts from the same verified result the batch was released on rather than a re-entered value.
Yes. Ingredients and APIs are linked at batch level, and because the raw material and finished product modules are integrated on one platform, a batch resolves to the material lots it consumed — and a raw material investigation resolves to the batches at risk.
Real-time trending by product, batch 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.
Nova-LIMS interfaces directly with chromatography data systems such as Empower, balances and other QC instrumentation so results are acquired rather than transcribed, and supports bidirectional SAP and ERP integration for product 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.
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Ready to Get Started?
Tell us how you manage specifications, run in-process and release testing and generate certificates of analysis today, and we will show you how Nova-FP would run it — not a canned walkthrough.