Pharmaceuticals: One Platform for Formulation and Quality
Pharmaceutical R&D, quality control, and product lifecycle management typically run on separate systems — formulation data in one tool, analytical results in a LIMS, specifications and audit trails somewhere else. Every change means re-entering the same data across tools, and reconstructing audit trails after the fact to stay ahead of an inspection.
Uncountable puts pharmaceutical R&D, formulation, quality control, and PLM on one structured, validated data layer. A drug product's formulation, process parameters, analytical methods, and specifications live on the same record as its QC release results, so assay, impurities, dissolution, and content uniformity are flagged in-spec or out-of-spec against the formulation and process behind them, with live SPC. Instrument data flows to LIMS to reporting across hundreds of analytical methods, and every change carries an automatic audit trail and e-signature aligned to 21 CFR Part 11 and EU Annex 11, built for ALCOA+.
Because R&D, QC, QMS, and PLM run on one data model instead of three tools stitched together, a change filters through the whole record with no re-entry — and each release comes with a GxP validation kit, IQ and OQ done for you.
See how one connected, audit-ready record can take your formulation and QC teams from development to batch release.
FAQs
How Uncountable connects pharmaceutical R&D, formulation, quality control, and PLM on one platform — from formulation development through QC batch release, with GxP-aligned traceability throughout.
A validation kit delivered with each platform release, including Installation Qualification (IQ) and Operational Qualification (OQ) already completed, so your team isn't building and executing that documentation from scratch every time.
Formulation data is the recipe — active ingredients, excipients, and process parameters like blend time and compression force. QC release data is the result — assay, impurities, dissolution, and content uniformity, checked against spec. Uncountable keeps both on the same drug-product record, so a release decision is never separated from the formulation and process behind it.
Every change is captured with an automatic audit trail and e-signature, aligned to 21 CFR Part 11 and EU Annex 11 and built for ALCOA+ data integrity, so audit-readiness comes from normal use of the platform rather than a separate compliance effort.
Instrument data flows into LIMS and through to reporting on one platform, standardizing hundreds of analytical methods so labs aren't manually transcribing results between disconnected systems.
