Water & steam
Purified water, WFI generation and distribution loops, clean steam, and CIP/SIP points of use.
Massive Dynamic for pharma & GMP
Commissioning and qualification in one traceable record.
Massive Dynamic models pharmaceutical utilities, cleanrooms and process systems, and keeps the evidence, sign-offs and validation documents in one record your quality team can inspect.
What it models
Systems and equipment
Cleanroom HVAC
Chillers, AHUs, graded ISO 7 and ISO 8 rooms, laminar flow cabinets and isolators.
Sterile processing
Autoclaves, bioreactors, freeze dryers and aseptic process trains.
Monitoring & control
BMS, EMS and the points a GMP facility continuously monitors.
Lifecycle
CQV from requirement to performance
Massive Dynamic runs a project in pharma vocabulary: the same stages, parties and documents your quality team expects.
- URS
User requirements captured against the systems they apply to.
- DQ
Design qualification per system and package.
- IQ
Installation qualification with checklists and documents per equipment type.
- OQ
Operational qualification, including shared tests across group equipment.
- PQ
Performance qualification and a handover package built from the record.
On Massive Dynamic
Built for inspection
Documents from the evidence
DQ, IQ, OQ and PQ documents are generated from the live tracker state with an e-signature, and export as .docx and print-ready PDF. Nothing is retyped.
Sign-off that means something
Sign-off needs the person's password, a valid training certificate and membership of the responsible party. If a stage has to be forced, the bypass is raised as an issue automatically.
An audit trail that cannot be edited
Every change is written to an insert-only log, designed around 21 CFR Part 11 expectations.
One record for group equipment
A bay-level test is one shared checklist across every asset it covers, never eight copies that drift.
GMP layouts in one click
In the Dirac panel, “Build pharma GMP layout” generates WFI, cleanroom HVAC and sterile processing systems as a starting point, or one system at a time.
Scoped access per system
A contractor sees only their system's project; your QA and management see the whole facility through the group.
In the app
From layout to IQ document
Split for independence. Group for visibility.
Each room or system runs as its own project, with its own access, schedule and qualification record, the way facilities are actually built and inspected. A project group shows them side by side for management, without blending independent systems into one misleading number.
Start with one system
Tell us about your project. A pilot on one system lets you judge Massive Dynamic on your own site.