Each module is gated by its own activation key controlling both the interface and the API. Activation and sidebar visibility are separate flags, so a licence can be held while the module stays out of the navigation rail. Adding a discipline later is a key, not a project.
ICH Q1A(R2)/Q1B/Q1D/Q1E study design, pull scheduling, chamber inventory, trending and shelf-life evaluation.
Controlled documents, change control, GMP certificates and client dossiers with a full signature chain.
Instrument and analyst capacity planning, conflict detection, certification matrix, downtime redistribution.
Non-conformance tracking with a structured corrective-action workflow and e-signature closure.
Training records, four-level competency assessment with reassessment expiry, and the skill matrix.
Reagents, chemical containers, standards and consumables with dual expiry, GHS segregation and hash-chained custody.
USP <1043> and Ph. Eur. §5.12 register with open-vial clocks, auto-lockout and 2D DataMatrix barcoding.
Grade A–D classified-area microbial and particulate monitoring with excursion investigation.
Rate-card, time-and-materials, volume-tiered and FTE billing with e-signed invoice generation.
Statutory zone sampling under UK Schedule 3 and EU 2020/2184, randomised auditable rounds and field routes.
Donor registry with consent scope, allele-level HLA typing across eleven loci, and read-level auditing.
Lot-level reagent register with quarantine and release, expiry monitoring and certificate attachment.
Forty-five minutes, screen-shared, with the person who built it. Bring a real SOP or method and we will model it live.