Guide
Your quality system is being built from scratch or has to bring several sites together: how does it become ready for inspection and audit?
Whether a quality system is new or grows from several sites: baseline, document structure, deviations, data integrity, inspection preparation and CAPA depend on each other. This page shows the stages in their order and links each one to the expert page with the details.
Typical triggers
- After a merger or acquisition, the quality structures the sites grew on their own no longer fit together.
- The company is growing fast and its quality structures are not keeping up, or the system is only now being built for new manufacturing.
- The SOPs describe procedures that are lived differently on site, and that only shows in the audit.
Last updated: October 19, 2026
The path in 6 stages
Stage 1
Take stock at each site
At the end, each site has a target-versus-actual comparison against the applicable requirements, and from it a prioritized action plan with responsibilities and a timeline. It separates what is critical from what is merely effort.
Stage 2
Set the standard and the structure
The decision on which standard governs the scope is made: the EU GMP Guide in the pharmaceutical environment, ISO 13485:2016 for medical devices and IVD. On it stand the shared process landscape, the document hierarchy, the responsibilities and the control of documents and records, before SOPs are written; SOP texts written before the standard and the control framework are settled produce documents that fall apart in the audit.
Stage 3
Bring deviations into one process
Every deviation follows a set path: classification by criticality, timelines, escalation and handover of the actions to the CAPA system. Recurring patterns become visible in the evaluation and feed back into the quality system.
Stage 4
Make the data hold up
The lab, QA and management work to concrete rules for each role. Audit trails are reviewed regularly and based on risk, every entry is attributable to a person, and no GxP decision may rest on an unprotected spreadsheet.
Stage 5
Get ready for inspection
The baseline and the timeline up to the inspection or the notified body audit are set, and a mock audit under inspection conditions has tested teams that got no warning. Because unannounced inspections and notified body audits are possible, readiness stays a permanent state.
Stage 6
After the findings
Deviations, audit findings and complaints feed into the same CAPA system, every action with a root cause analysis, owners and deadlines. An action is closed only when its effect is shown against predefined criteria.
How we work with you
How we work with you in the stages is set by the format: Strategy, Hybrid or Operational Consulting.
Track record
Projects that combined several stages
Frequently asked questions
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