Electronic Service Records (21 CFR Part 11)
Establishes IFS Cloud as the electronic system of record for medical device servicing activities, so that service records held electronically in place of paper satisfy 21 CFR Part 11 alongside the underlying Part 820 predicate rule. The design decides which records are Part 11 records, controls system access and electronic signature use, and preserves a time-stamped audit trail. Part 11 artefacts such as the audit trail and the validation record have no standard IFS Cloud object and are handled as system capability and controlled documents.
Execution steps
6 steps
The sequence somebody actually follows in IFS Cloud, step by step, written for a person doing the work rather than for a diagram.
Data requirements
14 requirements
Every entity this process needs, mapped to its IFS object, marked mandatory or optional, with the source system it comes from. This is the list a data migration is built from.
Configuration decisions
5 decisions
The choices this process forces you to make in IFS, named up front. Finding these in week nine of a program is what makes week nine expensive.
KPIs
5 measures
What this process is measured on, so the reporting requirement is known before the process is configured rather than after go-live.
Integration points
5 integrations
Where this process has to talk to something outside IFS, and what crosses the boundary.
Workshop questions
6 questions
The questions to ask the business about this process, written before the workshop. This is the difference between a design session and a discussion.
Prerequisites
4 prerequisites
What has to be true before this process can run at all: master data, other processes, setup completed elsewhere.
Industry variants
3 variants
How this process differs by industry: the parts a utility does differently from a manufacturer, already worked out rather than discovered.
Process diagram
1 BPMN diagram
A real BPMN diagram, editable in the platform, not a picture of one. It is the same diagram your team will annotate in the workshop.
Sources
5 citations
Where this came from. Every process traces back to IFS documentation and release notes, so a claim about how IFS behaves can be checked rather than believed.
Every process in the library looks like this.
48 details are already worked out for this one process. A license opens them, and the other 619 processes with them.