Quality Management System (QMS) with Uncountable: Close the Loop from Deviation to CAPA
In most labs, quality events live apart from the data that explains them. An out-of-spec result kicks off a hunt across systems: the deviation sits in one tracker, the CAPA in another, and the audit trail gets stitched together after the fact, by hand. Audit prep turns into a manual, night-before scramble, and each site ends up running its own version of the process.
Uncountable puts document control, audit management, training management, complaint management, CAPA and deviations, and change control on one governed system, connected to the same data as your R&D and QC. An out-of-spec result can auto-open a deviation and its CAPA, tied directly to the batch record and raw-material lot. Trace root cause to the resin lot, update the CAPA, and push the fix straight to the supplier's incoming spec — one action, one system, no re-entry.
Every change is captured automatically, time-stamped, and tamper-evident, with e-signatures that meet 21 CFR Part 11 and EU Annex 11. That's global harmonization across sites, without forcing every site into an identical process.
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FAQs
How Uncountable's quality management system (QMS) connects document control, audit management, training management, complaint management, CAPA and deviations, and change control into one governed system — and how each of those is tied to the same batch, formulation, and test data as your R&D and QC work.
A quality management system is the set of processes and records a regulated lab uses to control documents, investigate deviations, manage complaints, run audits, track training, and approve changes. In most labs these run as separate trackers stitched together after the fact; in Uncountable they run as connected modules on one platform.
A deviation is the record opened when something falls out of spec — an out-of-spec batch, for example. A CAPA (corrective and preventive action) is the investigation and fix tied to that deviation: the root-cause finding and the change made to prevent it from happening again, such as updating a supplier's incoming spec.
An out-of-spec batch automatically opens a deviation, tied to the batch record and raw-material lot. Root cause gets traced (for example, to a high molecular-weight resin lot), a CAPA opens, and the CAPA updates the incoming inspection spec — one action, one system, zero handoffs.
Every change to a document, phase, or approval is captured automatically, time-stamped, and tamper-evident, with e-signature support that meets 21 CFR Part 11 and EU Annex 11. Instead of assembling the audit trail by hand the night before an audit, it's already there.
