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Nova-FP
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.
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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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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.
