Plan a trustworthy data path.
Set the intended use and plant context. The other sections turn these choices into a traceable design and review checklist.
Project context
One record for a defined process or integration boundary.
Existing plant focus
Inventory what is already running before making changes.
Draft plans and checklists support engineering review. Qualification, Quality approval, and release remain with the site’s approved procedures and accountable people.
Review at a glance
Updates as you workFollow the data.
Document each handoff and keep equipment commands on a separate, approved path.
Connection design
Record the actual interfaces. A protocol choice alone does not prove data integrity.
Boundary checks
Keep monitoring separate from setpoint changes, recipe writes, and remote control.
Record zones, least privilege, individual or service identities, certificates, and allowed flows.
Size ingest rate, buffer capacity, retry windows, duplicate handling, and maximum outage duration.
Link batch and sample IDs, result status, units, method version, and approval state. Preserve the authoritative original and its audit trail.
Map assets and critical fields.
For each value, connect a real source to its destination, units, time source, and GxP purpose.
Add a field mapping
Use one row per value used by a production record or decision.
Field register
0 entriesRun it on controlled infrastructure.
Define where integration, operator access, analytics, and AI run and how each is maintained.
Infrastructure and endpoints
A managed thin client such as IGEL can standardize operator sessions and limit local changes. Validate the complete endpoint, application, identity, and update path for its intended GxP use.
Analytics and agentic AI
Use approved copies of operational data for analytics. Do not allow an agent to write directly to a PLC or regulated record.
Version models and prompts, evaluate data drift and false alarms, log inputs and outputs, and recheck after changes.
Uncertain, stale, or missing data must visibly stop the recommendation or route it to a person.
Decide what needs control.
Assess product quality, patient safety, data integrity, and operational reliability for each failure mode.
Record a risk
Start with a credible failure, then name the control and how it will be tested.
Control library
Use these as prompts; apply them according to intended use and site procedures.
The impact × likelihood number is a prioritization aid, not a release decision. Quality and process owners must assess critical risks under the site’s method.
Risk register
0 entriesProve the intended use.
Run the normal data path and challenge the failure cases. Record real evidence references rather than marking a test complete from a design assumption.
Add a site specific test
Plan for day two.
Assign owners, control changes, and make failures visible and recoverable.
System ownership
Operating limits
Readiness checklist
Attach procedure or ticket IDs in the notes below when reviewed.