Managed operations and support
Managed operations for audit-relevant Business Central environments
Releases, monitoring, and incident response for a system that has to stay in a validated state - including the changes Microsoft schedules for you.
Validation is not a project that finishes. Business Central Online ships two major updates a year plus continuous minor changes, and each one arrives whether or not your quality function was ready for it. A system validated at go-live and then operated without change control is not a validated system; it is a system that used to be.
We operate Business Central estates where the operational and the regulatory are the same problem. A release is assessed for regulatory impact before it lands, an incident produces a record as well as a fix, and the validated state is something that can be demonstrated on any given day rather than reconstructed before an inspection.
What we cover
Release and change management
Microsoft's cadence handled as regulated change rather than as an interruption.
Monitoring and incident response
Operational support where an incident also produces the record a regulated environment requires.
Periodic review and continued compliance
The recurring evidence that keeps the validated state defensible over years, not weeks.
Release and change management
- Major and minor release assessment against your validated functions, ahead of the update window
- Regression testing scoped by GxP impact, so the effort matches the risk rather than repeating full qualification
- Change records and updated validation documentation produced as part of the release, not chased afterwards
Monitoring and incident response
- Monitoring of integrations, jobs, and the data paths that carry GxP-relevant records
- Incident handling with root cause and corrective action documented to a standard your QA function can use
- Deviation support where an incident touched product or data integrity, rather than a ticket that closes silently
Periodic review and continued compliance
- Periodic system review against the current requirements and the current configuration
- Access and permission reviews, including the segregation of duties that drifts as people change roles
- Audit-trail and data-integrity spot checks, so a gap is found by us rather than by an inspector
How we deliver
- Defined response expectations agreed up front, sized to the operational reality rather than to a tier list.
- The same senior people across operations and advisory. Whoever answers an incident understands why the system was validated the way it was.
- Everything we do leaves a record your quality function owns. No knowledge that exists only in our heads or our ticket system.
- Transferable by design. If you take operations back in-house, the documentation supports that rather than obstructing it.
Related reading
- Audit Readiness Checklist for Business Central in Regulated Industries
- GxP Validation for Business Central - A Practical Guide
- ALCOA+ Principles and Business Central - Data Integrity in Regulated ERP
Is your validated state still demonstrable?
If you cannot say with confidence what the last three Business Central releases changed in your validated functions, or incidents close without a regulatory record, we offer a focused discussion to establish where the gaps are.