Request a GMP control demonstration
Discuss one manufacturing or quality action you want to govern. We will use a synthetic scenario to map the decision point and show the proof boundary.
Explore GxP change controls
Read the technical control model and regulatory context before a conversation.
Three GMP workflows worth controlling
Manufacturing batch release
Check before execution: Is the certifier authorized for this product and site? Is the exact batch record current? Are necessary quality conditions satisfied? Synthetic example: Hold or refuse release when facts are missing. Bind a single-use permission to one batch, record, certifier, and disposition.Regulated record modification
Check before execution: Who may edit the record? Does the reason, training status, and latest record version support the change? Synthetic example: Refuse unqualified, stale, or unauthorized edits. Distinguish audit-review evidence from permission to modify the record.Manufacturing process control
Check before execution: Is the setpoint or recipe change within an acceptable range? Are the required operator, supervisor, and equipment conditions met? Synthetic example: Refuse a proposed write at a simulated controller boundary when conditions do not hold. The control pattern can be applied to existing MES, ERP/WMS, LIMS, QMS, or OT pathways only after an actual execution boundary has been identified and tested. Intercepting a request at a dashboard is not equivalent to controlling the underlying action.See the before-and-after boundary
1
A consequential action is proposed
A user, service, or agent proposes releasing one batch, changing one regulated record, or writing one process parameter. The request identifies the exact action, target, actor, and relevant context.
2
Current authority and quality facts are checked
The proposed policy evaluates authoritative inputs: scope of authority, training, segregation of duties, quality-system facts, record version, and any additional conditions appropriate to that workflow.
3
An authorized action receives a bounded permit
Denied, held, or indeterminate requests cannot proceed through an enforcing gate. In the simulated permit flow, an allowed request receives a bounded, single-use permit.
4
Verify before the native system executes
The ERP/WMS, record-store, or controller adapter checks the permit and its binding before the side effect. If an adapter lacks a pre-execution check, it is observe-only and must not be described as preventing the action.
5
Keep decision and effect evidence separate
The authorization result and permit verification can be recorded. An actual batch status change, record write, or controller update is proven only by observed evidence from the execution system. A positive decision is not proof that an action ran.
What we can demonstrate today
The GMP testbed contains synthetic scenarios for batch-release decisions, regulated data integrity, and process-control writes. Examples include an open deviation blocking a proposed release, a stale record preventing a write, and an out-of-range setpoint being refused in a simulated enforcing adapter. The difference we show explicitly: an enforcing adapter can refuse a prohibited action before execution; an observe-only integration may detect a problem afterward but cannot claim prevention. A demonstration is not a production pilot, vendor certification, regulatory assessment, or validation package.Who should review this?
- QA and Quality Systems: control ownership, quality decision rules, deviation handling, and defensible evidence.
- Manufacturing and Operations: the exact point where batch stock status, records, or setpoints change.
- CSV/CSA and Validation: intended use, computerized-system boundaries, supplier qualification, testing, and traceability.
- IT, OT, and Security: identity, integration feasibility, fail-closed operation, and evidence readback.
Relevant regulatory context
Organizations may evaluate these controls against requirements relevant to their products and jurisdictions, including 21 CFR Part 211, 21 CFR Part 11, EU GMP Annex 11, and, for applicable EU batch certification, EU GMP Annex 16. Mapping a proposed technical control to a regulation is not a finding of compliance. See 21 CFR Part 11, EU GMP Annex 11, and AtlaSent’s published compliance status. Qualified customer QA, validation, and regulatory teams remain accountable for the intended-use determination.Frequently asked questions
Can I connect an actual manufacturing system today?
This page describes a synthetic testbed, not a generally available validated integration. A production path would first require the specific MES/ERP/LIMS/OT connection, quality-system review, and documented acceptance tests. We will not label an interface Enforcing until its execution boundary has been demonstrated.Does AtlaSent replace a QP, QA unit, MES, or electronic batch record?
No. AtlaSent is intended to support organizational authorization before an action. It does not make the product-quality decision, perform QP certification, replace the approved record, or stand in for the native system.Is an approval enough to prove a batch was released?
No. Approval, permit issuance, permit verification, native execution, and established effect are distinct facts. Each requires its own evidence.What happens on an unavailable data feed?
In the simulated enforcing flow, unresolved authorization facts or failed verification refuse execution. A real integration must prove that same behavior with the specific customer-controlled execution system before any prevention claim.Choose one decision to make safer
Bring one concrete action, the system where it executes, and the team that owns its authorization. We can use a synthetic scenario to identify the applicable policy inputs, show allowed and refused outcomes, and define what would be needed to move from demonstration to a customer-specific proof.Request a GMP control demonstration
Review your use case with AtlaSent. Synthetic demonstration; no validation or production-enforcement claim.
Review the technical documentation
See GxP change-control concepts, supporting authorization primitives, and related materials.