Pharmadex is a compliance platform for pharmaceutical and biotech manufacturers — controlled documents, electronic signatures, quality events on signed team boards, and a hash-chained audit trail. Document-centric, built for the shop floor, QA, and the auditor in the room next quarter.
Documents / Quality Work / Products / Equipment / Identity / Audit
Every module writes to the same identity layer, the same signature service, and the same append-only audit chain — so evidence is consistent everywhere an auditor looks.
Author SOPs, policies, and records in a controlled rich-text editor. Drafts move through dedicated review and approval queues to a single effective version — with every step signed and attributable.
Track deviations, quality events, and investigations as work items on a team kanban board. Stage moves into review and approval demand an e-signature; closed work is sealed and immutable.
Every signature requires fresh re-authentication and a 60-second single-use signing token. Signer, meaning, and timestamp are bound to the record and listed in a searchable signature register.
Every change lands in an append-only trail chained with SHA-256 hashes and enforced at multiple layers. A forensic console gives auditors filtered search over the full history.
Maintain a product catalog with versioned specification schemas. Compare schema revisions side by side, route specification changes through pending approvals, and import at scale.
Permission-gated access to every surface — users, roles, and teams administered in one place, with batch user import, idle session timeout, and an equipment register alongside.
Documents are authored in a controlled editor, not uploaded as loose files. Review and approval are separate signed steps with their own queues, so nothing becomes effective by accident.
Events, cases, and tasks flow through one team board — backlog intake, To Do, In Progress, In Review, Done. The moves that matter are gated by e-signature, not by convention.
Every action is attributable, time-stamped, and permanent — the audit layer is built for inspection from the schema up, and the signing ceremony leaves nothing ambiguous.
Pharmadex ships as a versioned, dedicated install with build traceability — so your validation package maps to a concrete release, and your data never shares a database with anyone else's.
Quality management for regulated manufacturers. See the document lifecycle, the signing ceremony, and the audit chain live — on your own dedicated install.
Compliance platform for regulated manufacturing