This is a ready-to-use log for tracking every finding a CDMO technical assessment produces, from initial identification through to a documented, closed disposition. It is the working record referenced throughout the technical assessment article: every finding gets a row, every row gets an owner and a date, and nothing is carried forward silently. Replace every <<FILL: ...>> placeholder with your own specifics. A filled sample row and instructions follow.
Document control header
| Field | Entry |
|---|---|
| Document title | CDMO Finding Disposition Register for <<FILL: program / CDMO name>> |
| Document number | <<FILL: e.g. DD-2026-04-REG>> |
| Version | <<FILL>> |
| Linked assessment | <<FILL: reference to the technical due diligence plan and scorecard>> |
| Register owner | <<FILL>> |
1. Purpose
This register captures every finding identified during the technical assessment of <<FILL: CDMO name>>, its disposition, its owner, and its closure status, so that no finding is dropped between the assessment record and the technical agreement, and so the same register can be extended into ongoing oversight after the contract is signed.
2. Field definitions
| Field | Format | Required | Who enters it | When |
|---|---|---|---|---|
| Finding ID | <<FILL: e.g. F-001>>, sequential | Yes | Lead assessor | At identification |
| Finding description | Free text, specific and factual | Yes | Assessor who identified it | At identification |
| Source | Which assessment activity surfaced it (e.g. equipment gap table, quality audit, reference call) | Yes | Assessor who identified it | At identification |
| Scope-critical (Yes/No) | Per the decision flow in the technical assessment article | Yes | Lead assessor with the relevant SME | Within 3 business days of identification |
| Disposition | Accept as is / Accept with interim control / Require remediation before first GMP batch | Yes | Lead assessor, confirmed by QA for any red flag | Before the assessment is marked complete |
| Owner | Named individual, not a function or team | Yes | Lead assessor | At disposition |
| Target date | Calendar date, not “before PPQ” alone | Yes | Owner, confirmed by lead assessor | At disposition |
| QA risk acceptance (if applicable) | Name and date, or N/A | Required for any risk-accepted red flag | Quality Assurance | Before disposition is finalized |
| Status | Open / In progress / Closed | Yes | Owner | Updated at each review |
| Closure evidence | Reference to the document, record, or data that closes the finding | Required at closure | Owner | At closure |
| Closure verified by | Name and date | Required at closure | Lead assessor or QA | At closure |
3. Instructions
Open a row the moment a finding is identified, even before its disposition is decided; an undated, unowned finding sitting in someone’s notes is the exact failure mode this register exists to prevent. Do not close a row on the owner’s own assertion alone; closure requires a named piece of evidence and a second person verifying it. Review the register’s open items on a fixed cadence, at minimum weekly during active diligence, and carry it forward unchanged into ongoing CDMO oversight after the contract is signed rather than starting a new, disconnected tracker.
4. Retention
Retain this register for the life of the CDMO relationship plus your organization’s standard record retention period after relationship close, consistent with retention for other quality records supporting product disposition and regulatory filings. Do not delete or overwrite closed rows; a closed finding with its evidence trail is itself part of the audit record.
5. Register
| Finding ID | Description | Source | Scope-critical | Disposition | Owner | Target date | QA risk acceptance | Status | Closure evidence |
|---|---|---|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL: Yes/No>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
6. Revision history
| Version | Date | Author | Summary of change |
|---|---|---|---|
<<FILL: 1.0>> | <<FILL>> | <<FILL>> | Initial issue. |
Filled specimen
Sample row from the assessment of a fill-finish CDMO for Acme Therapeutics’ ATX-410 lyophilized biologic.
| Field | Entry |
|---|---|
| Finding ID | F-003 |
| Description | CDMO’s lyophilizer chamber is roughly three times the scale ATX-410 was characterized on |
| Source | Equipment gap-assessment table |
| Scope-critical | Yes, shelf-load and heat-transfer profile at full load is unverified at this scale |
| Disposition | Require remediation before first GMP batch |
| Owner | CDMO tech transfer lead, jointly with Acme process SME |
| Target date | Before PPQ protocol approval, calendar date set at plan approval |
| QA risk acceptance | N/A, remediation path, not a risk acceptance |
| Status | Closed |
| Closure evidence | Bridging engineering run report ER-2026-014, showing shelf temperature uniformity at full load within the qualified range |
A second row from the same assessment, this one risk-accepted rather than remediated:
| Field | Entry |
|---|---|
| Finding ID | F-005 |
| Description | Potency reference standard sourced from a single, non-redundant vendor |
| Source | Analytical transfer readiness review |
| Scope-critical | No, a qualified backup lot already exists on Acme’s side |
| Disposition | Accept as is |
| Owner | Acme QC |
| Target date | N/A, documented risk acceptance on file |
| QA risk acceptance | J. Alvarez, Acme QA, 2026-08-14 |
| Status | Closed |
| Closure evidence | Risk acceptance memo RA-2026-021 |
The two rows show the pattern the register exists to force: the same table structure carries both a remediation and a risk acceptance, with the difference visible in the disposition and QA risk acceptance fields, not buried in prose that a later reader has to reinterpret.
Common inspection findings this register prevents
- A finding mentioned in a report or a meeting but never entered into a tracked register, so it has no owner, no date, and no visible status.
- A finding marked closed with no referenced evidence, closed on the owner’s own word alone.
- A red flag accepted informally in conversation with no documented Quality Assurance risk acceptance on file.
- A separate, disconnected tracker started for post-signature oversight, breaking the audit trail from the original assessment finding to its eventual resolution.
How to adapt this register
- Set your document number and the linked assessment plan reference in the header.
- Extend the field list in section 2 only if your quality system genuinely needs another field; do not drop any of the fields shown, each closes a specific gap seen in real diligence records.
- Set your review cadence in section 3 to match assessment intensity, at minimum weekly during active diligence.
- Set your retention period in section 4 to your organization’s documented retention schedule.
- Carry this same register forward into post-signature oversight rather than starting a new one.