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Quality & Compliance
Quality built into the work, not bolted on.
K3 runs quality as software, on the same systems behind every study — the controls hold whether or not anyone is watching. Qualify us when you're ready; most of it you can see in a single visit.
How we run quality
Two systems, not a binder.
K3's quality isn't a policy document describing intent — it's software we built, operate, and can show you. Compliance and records live in acaDMY, our electronic Quality Management System. Delivery quality and program risk live in Command Center. Both are inspectable on demand — down to the signature, the timestamp, and the before-and-after value.
acaDMY
eQMS · quality · documents · trainingOur electronic Quality Management System. Every quality process on this page — change control, CAPA, deviations, audits — plus controlled documents and training records, runs in acaDMY, a platform K3 built, validated, and operates.
- Training & qualification — role × state × site assignment, with retraining triggered automatically when a controlled document changes
- Part 11 signatures — identity taken from the account, re-authentication at signing, recorded meaning
- Tamper-evident records — a per-tenant hash chain with an independent verifier; completions and signatures are protected by append-only, tamper-evident audit records
- The quality system itself — change control, CAPA, deviations, audits, risk, complaints, and suppliers, each e-signed
- Its own validation package — GAMP 5 / FDA CSA: IQ, OQ, PQ, traceability matrix, and a Part 11 assessment, independently reviewed
Command Center
Delivery quality & oversightQuality in delivery is a different problem from quality in records. Command Center is where deliverable-level quality control and program oversight are tracked.
- Layered QC records — quality control captured against each deliverable, not asserted afterwards
- Risk register — probability × impact, tracked to resolution, with automated checks on critical scores
- Change audit — every change recorded with before-and-after values, actor, and timestamp
- Division-scoped isolation — multi-tenant separation across programs and studies
- Governance reporting — the same records your governance pack is generated from
The standards behind them
Regulatory framework
K3 operates to ICH GCP E6(R2) and the quality-by-design principles of E8(R1). Electronic records and signatures run on systems designed and validated to support 21 CFR Part 11, with tamper-evident audit trails. Data handling meets HIPAA requirements and, for EU-touching studies, GDPR.
Training & qualification
Every K3 professional's GCP, therapeutic, and state-level compliance is maintained in acaDMY — 250 courses across all 50 US states, auto-assigned by role and site, with retraining triggered automatically when a controlled document changes. Compliance evidence for a proposed team is a report we run during qualification, not a project we scramble.
Data standards
Deliverables conform to CDISC standards — SDTM, ADaM, Define-XML — validated against published conformance rules before anything reaches a reviewer. Standards versioning is controlled per study and documented in every submission package.
Audits & inspections
Sponsor audits are welcome — we staff them with the people who own the SOPs, not a liaison layer. We also conduct site and vendor audits on your behalf — qualification, routine, and for-cause — as part of study oversight. For regulatory inspections we support storyboard preparation, direct-question training, and real-time document retrieval from systems designed to answer quickly.
Frameworks we operate to
- ICH GCP — E6(R2), E8(R1), E9(R1)
- 21 CFR Part 11 — e-records & signatures
- CDISC — SDTM · ADaM · Define-XML
- HIPAA / GDPR — data privacy
Qualify us
- Vendor qualification — QMS walkthrough on request
- Team compliance — evidence generated on demand
- SOP review — under CDA, before contracting
Qualify us. We'll make it easy.
Request the QMS walkthrough and a compliance evidence sample — both available under CDA before you commit to anything.
Contact K3