Implementation and validation
Business Central implementation with validation built in
One engagement, not two. Configuration decisions and the evidence that justifies them are produced together, so the system is defensible the day it goes live.
Most regulated manufacturers run implementation and validation as two projects: a partner configures the system, then a quality function tries to document it afterwards. That sequence is where cost and risk accumulate. Decisions get made without a record of why, and validation becomes archaeology - reconstructing intent from a finished configuration.
We run them as one. Requirements are written so they can be tested, configuration is traced back to them, and the qualification evidence accumulates as the build proceeds rather than at the end. The effort is scoped by risk under GAMP 5, so it lands on the functions that affect product and patient - not spread evenly across a system where most of it does not matter.
What the engagement covers
Requirements and risk scoping
A requirements set written to be testable, and a risk assessment that decides where validation effort goes.
Configuration and build
The system built against those requirements, with the decision record produced as work proceeds.
Qualification and go-live evidence
IQ, OQ and PQ executed against the traced requirements, leaving the evidence an inspection expects.
Requirements and risk scoping
- User and functional requirements captured in a form that can be traced and tested, not a wish list
- GAMP 5 categorization across Business Central, its extensions, and the integrations in scope
- Risk assessment driving the depth of qualification per function, documented so the reasoning survives staff changes
Configuration and build
- Configuration and, where genuinely needed, AL extensions - kept to what the requirement justifies
- Design and configuration specifications maintained as living documents, not written retrospectively
- Change control from the first configuration decision, so the audit trail starts before go-live rather than after
Qualification and go-live evidence
- Installation, operational, and performance qualification proportionate to the assessed risk
- Requirements-to-evidence traceability that answers an inspector's question directly
- Validation summary report and a handover your quality function can own and maintain
How we deliver
- Scoped in phases with a written deliverable at each one, so the engagement can be stopped or re-scoped without leaving a half-documented system.
- Validation effort proportionate to risk. We will tell you where testing is not warranted, which is usually the larger saving.
- Senior involvement throughout. The people who scope the validation are the people who execute it.
- Documentation handed over in a form your team maintains. We do not build a dependency on us to keep the system compliant.
Related reading
- Computer System Validation - Step by Step for Business Central
- ERP Implementation Checklist for Regulated Manufacturers
- GxP Validation for Business Central - A Practical Guide
Planning an implementation or a re-implementation?
If you are scoping a Business Central project in a regulated environment, or inheriting one that was implemented without a validation record, we offer a focused discussion to establish what the validation scope actually needs to be.