Industries
API manufacturing
Active pharmaceutical ingredient manufacturers sit at the raw-material end of the supply chain, where a single unqualified supplier or an expired certificate can hold up every formulator downstream — while the customer accounts, quotes, and orders that move that same material out the door usually live in a completely separate system that knows nothing about the qualification status behind them.
What usually goes wrong
- Confirming an incoming raw-material lot has a valid, in-spec, currently-qualified CoA on file before it reaches the line is usually nobody’s discrete job across QMS, ERP, and LIMS software for API manufacturers.
- Export certificates (CoAs, CoPPs, WHO-GMP) carry real expiry dates tracked in whatever spreadsheet survived the last handover, so a shipment gets held at customs when one quietly lapses.
- Customer and order records disconnected from the supplier qualification and stability data behind the material actually being sold.
How Plumely helps
Confirming an incoming raw-material lot has a valid, in-spec, currently-qualified CoA on file before it reaches your line is the single most common gap we’ve found across QMS, ERP, and LIMS software for API manufacturers. Our Supplier & CoA Qualification tool exists specifically to own that check — alongside the CRM your sales team already needs for the customers that material ships to.
- 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.
- Export Documentation & Compliance — CoAs, CoPPs, WHO-GMP certificates, and shipping documents — tracked, versioned, and never expired without warning.
- 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.
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, export documentation, and stability data, 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.
Compliance & security
Every organization’s data is isolated at the database layer, and material actions are written to an append-only, hash-chained audit trail. ICH Q7 is the reference guideline most API manufacturers build their quality system against, particularly around raw-material qualification, batch documentation, and supplier oversight — Plumely is built with those workflows in mind, but we don’t claim certification against ICH Q7 or any other standard; that determination is your quality system’s to make. Read more on our security & architecture page.