Pharmaceutical manufacturing

What usually goes wrong

• ✓Documentation spread across shared drives, spreadsheets, and email, with no single source of truth for an auditor to follow.
• ✓Deviations logged after the fact from memory, and CAPAs closed by flipping a status with no real accountability step behind it.
• ✓Export certificates and dossier requirements tracked by whoever remembers to check the expiry date.
• ✓Customer accounts, quotes, and orders living in a generic CRM (or a spreadsheet) with no connection to the quality records behind the batches actually shipped.

How Plumely helps

• Companies, Contacts & Pipeline — Track the companies and contacts you sell to, log leads, and manage opportunities through your pipeline — the CRM foundation every other tool plugs into.
• Products — A unified sellable catalog — SKUs, pricing, and units of measure — that quotes, orders, and invoices draw their line items from.
• Quotes, Orders & Invoices — Build a quote, convert it to an order once accepted, then invoice it — with line items flowing forward at every step so nothing gets re-typed.
• Workflows — Automate the busy work — when a record is created or its status changes, create a follow-up task or notify the record's owner automatically.
• Supplier & CoA Qualification — Verify every incoming batch has an in-spec, non-expired CoA from a qualified supplier before it reaches your line.
• Country Dossier Checklist — Living, country-specific dossier checklists for CTD, ACTD, and Module 1 requirements across emerging markets.
• Export Documentation & Compliance — CoAs, CoPPs, WHO-GMP certificates, and shipping documents — tracked, versioned, and never expired without warning.
• RLD / Orange Book Comparator — Follow reference-listed drugs for label, patent, and exclusivity changes without checking the FDA site by hand.
• Protocol Amendment Impact Checklist — Turn a protocol amendment into an owned, tracked checklist across every affected system and document.
• Deviation & CAPA Tracker — Mobile-first deviation logging and CAPA tracking built for the shop floor, not just the QA office.
• Stability Study Tracker — Pull-point calendars, sample inventory, and overdue-test alerts for every active stability study.
• Clinical Trial Lite Manager — Protocol tracking, enrollment logs, and essential-document checklists sized for a 1-3 study site.

One system, not two

Plumely isn’t a CRM bolted onto a quality system, or the other way around — companies, contacts, quotes, and orders live in the same place as supplier qualification, deviations, stability data, and export documentation, so a customer record can show you everything connected to that account without switching tools. Activate the modules your team actually needs and skip the rest — including an enterprise QMS suite built and priced for organizations that can afford a long implementation timeline and named-user licensing across every module, whether or not the team uses them all.

Compliance & security

Every organization’s data is isolated at the database layer, material actions are written to an append-only, hash-chained audit trail, and deviation closures carry a real electronic-signature step. Using Plumely supports common practices expected under GxP recordkeeping and 21 CFR Part 11 — compliance itself is a shared responsibility with your own validated procedures. Read more on our security & architecture page.