Pharma & Biotech

For CMC, formulation and process development, analytical and stability, and QC and validation teams in biopharma. Trace every batch to its lots, check each release result against its spec, and follow stability next to the formulation.

Learn how a connected ingredient record links fermentation, downstream processing, analytical results, specifications and application evidence to support supplier changes, customer investigations and commercial ingredient decisions.

Explore a digital CMC blueprint that connects pharmaceutical development, technology transfer, manufacturing and quality. Learn how governed data links scientific evidence, process knowledge and decisions across the lifecycle.

How biopharmaceutical teams connect every drug product lot to its drug substance, release results, specifications and stability data, so a failed result starts from the lot, not a search across systems.

How pharmaceutical teams connect formulation, analytical QC, and PLM on one validated data layer, with GxP-aligned audit trails, e-signatures, and a validation kit for every release.

How Uncountable ships a complete GAMP 5 validation kit with every quarterly release (VMP, FMEA, RTM, and signed OQ evidence) so regulated teams validate their own configurations, not the platform itself.

Unexposed EM plates recorded as sampled. Failing samples discarded before analysis. Two recent FDA warning letters show how QC records can drift from what happened, and what teams should check in their own workflows...

The same room can be ISO 7, Grade C or zone 3 depending on who you ask. What ISO 14644-1, EU GMP Annex 1 and food hygienic zones each tell you, and how to record classification so it stays useful...

A batch can meet every release criterion and still behave differently in a customer application. This article explains when a specification result is enough, and when industrial-biotech teams need connected process, application, and quality evidence.

A Part 11-ready ELN needs more than an audit log and an approval button. Use this seven-point checklist to assess audit trails, access controls, e-signatures, validation evidence, retention, exports, and controlled workflows.

Most monitoring plans have a sampling point nobody can explain. How to design a cleanroom plan whose reasoning survives line changes, reclassifications and the years after qualification...

Pharma 4.0 is pitched as a connectivity story, but AI-ready, FAIR, and connected are data problems, not machine problems. Structure your R&D and quality data first, thread it across the enterprise, then apply AI. Data first, intelligence follows.

With Uncountable, Merck KGaA, Darmstadt, Germany plans to build a centralized, structured data environment that connects instrument data, Laboratory Information Management Systems (LIMS), and reporting within a single platform.

Locus Fermentation Solutions (Locus FS) has selected Uncountable to centralize its laboratory and operational data and strengthen its Quality Assurance, Quality Control, and Regulatory workflows.

Arsenale Bioyards has chosen Uncountable to revolutionize bio-manufacturing with AI-driven laboratory informatics. By integrating Uncountable’s LIMS and ELN solutions, Arsenale is streamlining R&D workflows, enhancing efficiency, and accelerating the

MEGGLE GmbH&Co. KG, Business Unit Excipients, has selected Uncountable as its integrated knowledge management platform for its R&D team.‍MEGGLE Business Unit Excipients has provided the pharmaceutical industry for more than seventy years. The goal...