This is a ready-to-use mapping matrix. It pins each provision added under 21 CFR 4.4 to the procedure that satisfies it, the evidence that demonstrates it, the applicability decision with rationale, and the accountable owner. It supports the combination product quality plan. Replace every <<FILL: ...>> placeholder, use the table that matches your base, and route it through document control. A worked filled specimen follows. Verify each cited regulation against the current source before you rely on it.
Control header
| Field | Entry |
|---|---|
| Document number | <<FILL: MX-ID>> |
| Product | <<FILL>> |
| Base operating system | <<FILL: 211 base OR 820/QMSR base>> |
| Linked quality plan | <<FILL: QP number>> |
| Version / date / owner | <<FILL>> |
Table A: Drug/biologic base, device provisions added (21 CFR 4.4(b)(1))
Use this table if your base is 21 CFR 210/211.
| Provision | Section | What it must demonstrate | Procedure | Evidence / record | Applicable (Y/N + rationale) | Owner |
|---|---|---|---|---|---|---|
| Management responsibility | 820.20 | Quality policy and objectives, organization, management representative, management review covering device scope | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Design controls | 820.30 | Design plan, inputs, outputs, review, verification, validation (incl. human factors), transfer, changes, DHF | <<FILL>> | <<FILL: DHF>> | <<FILL>> | <<FILL>> |
| Purchasing controls | 820.50 | Device supplier evaluation, purchasing data, supplier agreements | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| CAPA | 820.100 | Capture of device failure modes, investigation, action, effectiveness, management awareness | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Installation | 820.170 | Installation and inspection instructions and records, where applicable | <<FILL>> | <<FILL>> | <<FILL: often N/A>> | <<FILL>> |
| Servicing | 820.200 | Servicing procedures and records, where servicing is a specified requirement | <<FILL>> | <<FILL>> | <<FILL: often N/A>> | <<FILL>> |
Table B: Device base, drug provisions added (21 CFR 4.4(b)(2))
Use this table if your base is 21 CFR Part 820 / QMSR.
| Provision | Section | What it must demonstrate | Procedure | Evidence / record | Applicable (Y/N + rationale) | Owner |
|---|---|---|---|---|---|---|
| Component/container/closure testing | 211.84 | Sampling and testing of incoming drug components, with approval or rejection before use | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Calculation of yield | 211.103 | Actual and theoretical yield at appropriate phases | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Tamper-evident packaging | 211.132 | Tamper-evident packaging for OTC drug products | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Expiration dating | 211.137 | Scientifically justified expiration dating supported by stability | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Testing and release | 211.165 | Batch testing for identity, strength, conformance before release | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Stability testing | 211.166 | Written stability program with intervals, conditions, sound sampling | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Special testing | 211.167 | Sterility, pyrogen, or other special tests where required | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
| Reserve samples | 211.170 | Retention of reserve samples for required periods | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Acceptance criteria
- Every applicable added provision maps to a named procedure and a real evidence record.
- Every N/A carries a written rationale.
- The base matches the quality plan, and only the relevant table is used.
- The matrix is approved by QA and kept current as procedures change.
References
21 CFR Part 4, 4.4(b)(1) and 4.4(b)(2); 21 CFR Parts 210/211; 21 CFR Part 820 / QMSR; ISO 13485:2016.
Confirm the current version and clause numbers before issue.
Filled specimen
Drug-base case for an example prefilled syringe (drug-led). Illustrative.
| Provision | Section | Procedure | Evidence | Applicable | Owner |
|---|---|---|---|---|---|
| Management responsibility | 820.20 | Quality manual, management review SOP extended to device scope | Management review minutes | Yes | Site quality head |
| Design controls | 820.30 | SOP-DC-001 plus syringe DHF; HF validation per IEC 62366-1 | DHF, HF study report | Yes | Device engineering |
| Purchasing controls | 820.50 | Supplier qualification SOP, device criteria | Supplier audit, agreement | Yes | Supplier quality |
| CAPA | 820.100 | CAPA SOP, scope expanded to delivery malfunction and use error | CAPA records | Yes | Quality systems |
| Installation | 820.170 | N/A: patient-administered, not installed | Documented rationale | N/A | Quality |
| Servicing | 820.200 | N/A: single-use disposable | Documented rationale | N/A | Quality |
This is the artifact that turns “we comply with Part 211” into a defensible demonstration that the device provisions were each addressed.
Common inspection findings this matrix prevents
- A provision named in the plan but with no procedure or evidence behind it.
- An N/A with no rationale.
- Both base tables filled in, signaling the team ran two full systems instead of the streamlined approach.
How to adapt this matrix
- Set your document number and link the quality plan.
- Keep only the table that matches your base; delete the other.
- Map each applicable provision to a real procedure and evidence record.
- Give a rationale for each N/A and have QA approve.