Under QMSR, cleanroom projects fail when leaders cannot demonstrate risk-based control of what was built, what changed, and what was accepted. Turnover becomes quality evidence, not project closeout paperwork.
What changes on February 2, 2026
FDA’s Quality Management System Regulation (QMSR) amends 21 CFR Part 820 and becomes enforceable on February 2, 2026. QMSR aligns Part 820 with ISO 13485:2016 through incorporation by reference.
The most important change for project leaders is inspection visibility. Under the legacy regulation, 21 CFR 820.180(c) limited FDA access to certain reports, including management review reports, quality audit reports, and supplier audit reports. FDA’s QMSR FAQ confirms QMSR does not maintain that exception, so reports previously exempt under 820.180(c) are now subject to inspection.
Scope check for executives
Part 820 applies to manufacturers of finished medical devices and to the operations within scope. For mixed-use sites, apply QMSR expectations to the areas and systems that support device operations under Part 820.
If a cleanroom, utility, automation layer, or contamination-control system can affect device safety, quality, or regulatory compliance, the project record belongs in the QMS evidence trail, even if the project organization reports outside QA.
Why turnover becomes quality evidence
QMSR reinforces risk management and risk-based decision-making across QMS processes and the device lifecycle. FDA’s CDRH training materials explicitly frame QMSR around risk management, a risk-based approach, and risk-based decisions.
Once FDA can review management review outputs and audit reports, weak project evidence becomes a leadership and governance problem. Risk files and management reviews should point back to the project’s objective evidence. When the trail is thin, inspectors will see the gap between documented intent and actual control.
Three project areas most likely to surface under QMSR
1) Supplier control and performance history
CMs, GCs, cleanroom OEMs, skid vendors, controls integrators, and specialty subs become quality-relevant suppliers when they influence contamination control, monitoring, alarms, or validated process capability. Under QMSR, qualification at award is not enough. Management review and internal audits should draw on supplier performance and issue history, including nonconformances, deviations, rework, and closure quality. FDA’s FAQ makes clear that supplier audit reports can be inspected.
2) Change control tied to risk
Projects change. Inspectors will focus on whether you approved changes, maintained traceability, and justified decisions against risk. Uncontrolled field decisions create audit exposure by weakening risk-based controls. QMSR’s framing makes this a governance issue, not a formatting issue.
3) Acceptance evidence and traceability, including data integrity
Expect scrutiny on whether the organization can reconstruct requirements, as-built status, test evidence, deviations, and acceptance decisions. That includes environmental monitoring, alarm handling, and data integrity across automation interfaces when those systems support regulated operations. If internal audits or management review cannot tie risk and performance back to objective evidence, QMSR-era inspections will expose the disconnect.
A QMSR-aligned pressure test before turnover
These questions mirror how QMSR-era management review and audits will probe your ability to demonstrate risk-based control of project delivery.
- What changed from design intent, and where is the approval trail tied to risk?
- Which suppliers were quality-relevant, and what evidence supports acceptance and ongoing control?
- What objective tests prove environmental control and monitoring behavior, including alarms and interfaces?
- What remained open at handover, what interim controls were in place, and how did the team govern closure?
- Where is the single index that ties requirements to evidence to acceptance?
If the team cannot answer quickly, the organization will respond later in audit time, remediation cost, and schedule impact.
Hygenix Documentation Master Planning
Most organizations do not fail because they lack documents. They fail because documentation has no governance across cleanroom projects. Hygenix Documentation Master Planning provides that governance.
A Documentation Master Plan defines how teams create, review, approve, store, and retrieve project evidence before execution begins. It also defines what “complete” means at each phase so turnover is auditable, searchable, and defensible.
Depending on your scope, Hygenix Documentation Master Planning can include:
- PHA integration and traceability into design decisions and changes
- URS that drives measurable acceptance criteria and testing strategy
- RFP packages that lock supplier evidence requirements before award
- Documentation specifications that define deliverable content, format, and acceptance standards
- Site or project-specific QMS and Safety Plan alignment for contractors and vendors
- ETOP structure, meaning an electronic turnover package indexed to requirements and tests
This is how you demonstrate that risk management and supplier control are documented in project records, not just in SOP language.
Make turnover defensible before QMSR enforcement
If you have a 2026 cleanroom build, expansion, or retrofit that supports medical device operations under Part 820, request a Hygenix Documentation Master Plan and a QMSR Turnover Documentation Readiness Review. We will define the minimum evidence set you need, identify where your current turnover approach will break under audit and management review visibility, and structure turnover so you can defend the project in an FDA inspection under QMSR.