This is a ready-to-use internal memorandum template, not legal advice and not itself a disclosure to any health authority. Its purpose is narrow: to organize, in one place, the factors a company would weigh when deciding whether to proactively tell a regulator about a data integrity problem beyond whatever reporting obligation already applies on its own clock (a Field Alert Report, a Biological Product Deviation Report, a safety report, or a contractual notification). The decision to disclose, and the content, timing, and channel of any disclosure, is made by Legal and senior quality leadership, informed by qualified legal counsel, never by this document or by the person who drafts it. Replace every <<FILL: ...>> placeholder. Treat the completed memo as privileged or confidential per your own legal function’s direction; mark and route it accordingly. A filled specimen follows, describing an illustrative, invented scenario only.
Document control header
| Field | Entry |
|---|---|
| Memorandum title | Self-Disclosure Factors-Considered Memorandum |
| Document number | <<FILL: reference>> |
| Linked investigation number | <<FILL: DI-INV-ID>> |
| Date | <<FILL>> |
| Prepared by | <<FILL: name, role>> |
| Reviewed with | <<FILL: Legal contact, name>> ; <<FILL: senior quality leader, name>> |
| Privilege / confidentiality marking | <<FILL: per your legal function's instruction>> |
1. Purpose and framing
This memorandum records the factors considered in weighing a discretionary self-disclosure to <<FILL: relevant health authority or authorities>>, separate from and in addition to any reporting obligation already triggered on its own regulatory clock (see section 3). It is an analytical aid prepared for Legal and senior quality leadership. It does not recommend a specific disclosure action, does not constitute legal advice, and does not authorize any communication to a regulator. The decision rests with Legal and senior quality leadership.
2. Summary of the underlying finding
| Field | Entry |
|---|---|
| Nature of the finding | <<FILL: brief, factual, from the investigation record>> |
| Extent determined | <<FILL: population, cross-reference to the extent statement>> |
| Data-reliability verdict(s) | <<FILL: per data set, cross-reference to Phase 5 verdicts>> |
| Product / patient impact | <<FILL: lots, distribution, exposure, cross-reference to impact assessment>> |
| Root cause classification | <<FILL: system gap / intentional act / both>> |
3. Mandatory obligations already assessed (not a judgment call)
| Obligation | Applicable? | Basis | Status |
|---|---|---|---|
| Field Alert Report, 21 CFR 314.81(b)(1)(ii) (approved drug product) | Y/N | <<FILL>> | <<FILL: filed / in progress / not applicable>> |
| Biological Product Deviation Report, 21 CFR 600.14 (licensed biological product) | Y/N | <<FILL>> | <<FILL>> |
| Safety / pharmacovigilance reporting | Y/N | <<FILL>> | <<FILL>> |
| Contractual / quality agreement notification | Y/N | <<FILL>> | <<FILL>> |
This section exists so the discretionary question in section 4 is weighed against what is already required, not confused with it. A mandatory filing on one lot does not resolve the broader question of whether the pattern behind it warrants more.
4. Factors considered for the discretionary question
| Factor | Observation | Source |
|---|---|---|
| Severity and scope of the finding beyond what any mandatory filing already covers | <<FILL>> | <<FILL: extent statement>> |
| Whether product reached, or could have reached, patients beyond what a mandatory filing addresses | <<FILL>> | <<FILL: impact assessment>> |
| Completeness of the remediation already in place or planned | <<FILL>> | <<FILL: CAPA record>> |
| Whether the problem was found by the company itself, before any external party raised it | <<FILL>> | <<FILL>> |
| Likelihood and timeline of independent discovery by an inspector or other external party | <<FILL: factual assessment, not a prediction of enforcement outcome>> | <<FILL>> |
| Prior compliance history at the site or with the authority | <<FILL>> | <<FILL>> |
| Readiness to present a complete, defensible investigation record if asked | <<FILL>> | <<FILL>> |
Each row records an observation, not a conclusion about what the company should do. The weighing of these factors against each other is Legal’s and senior quality leadership’s task, not a calculation this memo performs.
5. Options noted for leadership’s consideration
| Option | What it would involve | Noted by |
|---|---|---|
| Proactive disclosure beyond mandatory filings | <<FILL: what would be communicated, to whom, on what approximate timeline>> | <<FILL>> |
| Complete remediation without additional proactive disclosure, beyond mandatory filings already made | <<FILL: basis for this option being on the table>> | <<FILL>> |
Defer the decision pending <<FILL: e.g. completion of the wider trust review>> | <<FILL>> | <<FILL>> |
This section lists options for the decision-makers; it does not rank or recommend among them.
6. Decision and basis (completed by Legal and senior quality leadership, not by the preparer)
| Field | Entry |
|---|---|
| Decision | <<FILL>> |
| Decision made by | <<FILL: name(s), role(s)>> |
| Date | <<FILL>> |
| Basis recorded | <<FILL>> |
7. Distribution and retention
Distribute only to the individuals named in section 6 and others Legal specifically directs; retain per your legal function’s instruction on privileged or confidential materials, and reference it from the investigation file without attaching the full memorandum if your legal function directs otherwise.
8. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL: date>> | <<FILL: author>> | Initial issue. |
Filled specimen
The scenario below is illustrative and invented; it does not describe any real company, product, or event.
| Field | Entry |
|---|---|
| Nature of the finding | Re-integration pattern on a release-testing instrument, traced to a shared login used by three analysts over 18 months |
| Extent determined | 40 batches across 3 instruments; 4 people implicated, one of them not individually identifiable due to the shared login |
| Reliability verdict | 38 batches reliable after correction from valid originals; 2 batches not reliable, no valid original survives |
| Mandatory obligations | Field Alert Report filed on the 2 not-reliable lots within the 3-working-day clock; no biological product involved |
| Discretionary factors noted | Pattern spans 18 months and 3 instruments, beyond the 2 lots the mandatory filing covers; found through routine audit trail review, not a tip or external notice; CAPA for the shared-login gap already implemented site-wide at the time of this memo |
| Options noted | Proactive disclosure of the broader pattern beyond the 2-lot filing; complete the wider trust review first and revisit; remediate and monitor without further disclosure |
| Decision and basis | left blank in the specimen; this is Legal’s and senior quality leadership’s entry, not a scripted example of what they should decide |
The specimen stops short of filling in section 6 on purpose. Showing an invented “decision” would misrepresent this document as something that decides the question; it only organizes what the decision-makers need to weigh.
Common pitfalls this memorandum format is built to avoid
- Treating a mandatory filing (Field Alert Report, Biological Product Deviation Report) as if it resolved the separate, discretionary question about the broader pattern.
- A memo that recommends a specific disclosure action, which turns an analytical aid into something that reads as legal advice or a predetermined conclusion.
- Deciding the discretionary question before the extent and impact assessment is complete, which is the same premature-reportability error the investigation SOP is built to prevent.
- No clear record of who actually made the decision, leaving it unclear whether the call was made by the people accountable for making it.
How to adapt this memorandum
- Confirm with your own Legal function how it wants privileged material marked, routed, and retained before this template is ever used, and adjust the header accordingly.
- Keep section 4 as observations tied to a source document; do not let it drift into recommendations.
- Leave section 6 for Legal and senior quality leadership to complete; do not pre-fill it as part of drafting the memo.
- Confirm the current citation and timeline for any mandatory filing in section 3 against the regulation in force before you rely on it.