Compliance that lives in the architecture, not a binder.
CMS Life Sciences is governed by construction: every governed change carries the ALCOA+ principle it satisfies, every mutation captures a reason-for-change, and the audit trail is hash-chained — each entry sealed to the one before it, so any alteration is detectable by anyone who checks. Your QA team reads the configuration directly — they don't have to trust us.
Governance by construction vs. by configuration.
Traditional enterprise systems prove compliance by validating a configuration, then re-validating on every change. CMS Life Sciences builds compliance into the node architecture itself, so validation still happens: it's continuous and built in, not a manual re-do.
Governance by configuration
- Compliance lives in a validated configuration document
- QA validates that configuration produces compliance
- Every change triggers expensive re-validation
- You hold a vendor license — stop paying, stop running
Governance by construction
- Compliance lives in the node architecture
- QA reads the EaC configuration directly
- A node change is itself readable and auditable
- You own portable artifacts your internal team can keep evolving
Every principle, mapped to the architecture.
The mapping names all nine ALCOA+ principles and shows, for each, the mechanism that enforces it — or marks it unmapped. A principle with no enforcing mechanism is rendered rather than omitted, so a satisfied principle and an absent one never look the same. This is how compliance becomes something you can read, not something you take on faith.
| Principle | How CMS Life Sciences implements it |
|---|---|
| Attributable | Every action traced to a person or system + timestamp |
| Legible | Readable, permanent records (non-editable storage) |
| Contemporaneous | Recorded at the moment of action |
| Original | First-recorded source preserved; copies flagged |
| Accurate | Corrections documented; the original is never deleted |
| Complete | All events captured — not just successes |
| Consistent | Logical chronology via platform time sync |
| Enduring | Durable across the full retention period |
| Available | Accessible for audits via surface views + export |
The regulatory baseline, built in.
21 CFR Part 11
Digital records with a hash-chained audit trail your auditors can verify independently — every governed change is attributable, contemporaneous, and carries a structured reason.
GxP
Structured reason-for-change captured on every governed data mutation, enforced by a build-time gate rather than by review.
ICH GCP
Ethics-approval tracking with expiry alerts and consent gating.
Feature-locked dashboards, controlled by access rights.
Every screen is gated by access rights, so each role sees exactly the dashboards and actions it's authorized for — completely compliant and tested. “Vaccines doesn't want to see medicines” is a configuration, not a code branch.
- samples:view · samples:receive · samples:reconcile
- biobank:query · biobank:manage · biobank:accession · storage:manage
- compliance:view · compliance:export · review:approve
- custody:approve · admin:access
“Start with us. Keep developing with your own team.”
Your workspace configuration, ALCOA+ mapping, and runbooks are version-controlled, portable, and readable by your QA team without software expertise. Begin the build with us, then hand it to your internal team to keep evolving — you own the compliance artifacts either way.
Show your auditors compliance they can read.
We'll walk your QA and CSV teams through the ALCOA+ mapping node by node.