Matrix: Validation Project RACI

This is a ready-to-use RACI (Responsible, Accountable, Consulted, Informed) matrix for a validation or qualification project. Build it once per project at the plan stage, get it approved alongside the validation plan, and refer back to it whenever a deliverable stalls because “I thought someone else owned that.” Replace every <<FILL: ...>> placeholder with your own roles and names. A worked filled specimen follows the template. Verify each cited regulation against the current source before you rely on it.

Document control header

1. Purpose

This matrix assigns exactly one Accountable role and one or more Responsible, Consulted, and Informed roles to every deliverable in the validation project named above, so that ownership is explicit before work starts rather than discovered when a deliverable is late. It is approved alongside the validation plan and referenced at every stage gate.

2. The four roles, defined

• Responsible (R): does the work. A deliverable can have more than one Responsible party.
• Accountable (A): owns the outcome and signs for it. Exactly one Accountable role per deliverable, never zero, never two. Two accountable parties on one deliverable means, in practice, none.
• Consulted (C): provides input before the work is finalized. Two-way communication, sought out for expertise or impact.
• Informed (I): told after the decision or the work is complete. One-way communication, no input expected.

3. How to build this matrix

1. List every deliverable from the validation plan’s deliverables list down the left column. Do not skip minor deliverables; ambiguity hides in the ones people assume are obvious.
2. List every role that touches the project across the top: validation lead, system/process owner, QA, SMEs or business users, vendor, IT/infrastructure, and any others specific to this project (regulatory affairs for a submission-linked system, data migration lead, security).
3. For each cell, assign one letter. A deliverable row must contain exactly one A. If you cannot decide who is Accountable, that is itself a finding: escalate to the project sponsor before proceeding, do not guess.
4. Route the completed matrix through the same approval as the validation plan; it is not a working draft, it is a controlled commitment.
5. Revisit the matrix at every stage gate. If a role changes (a vendor resource turns over, a new SME is added), update it under change control the same way you would update the plan.

4. The matrix

5. Acceptance criteria

• Every row has exactly one Accountable entry.
• Every deliverable in the approved validation plan appears as a row; no deliverable is left unassigned.
• QA is Accountable or Consulted, at minimum, on every quality-relevant deliverable, and is Accountable for deviation disposition.
• The business or process owner is Accountable for the user requirements and named as Responsible or Consulted on PQ/UAT, because intended use is a business determination.
• No role is Accountable for a deliverable it also independently reviews or approves in a second capacity that would remove independence (for example, the same person cannot be the sole Accountable author and the sole QA approver of the same record).
• The matrix is approved before execution begins and is version-controlled alongside the plan.

6. References

GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems, Second Edition (ISPE), for the risk-based, planned lifecycle this matrix supports. EU GMP Annex 11, general principles on organization and personnel accountability for computerised systems. ICH Q10, Pharmaceutical Quality System, for management responsibility and defined roles within the quality system.

Confirm the current version of each reference before issue.

7. Revision history

8. Approvals

Filled specimen

The following shows the matrix completed for an example configured LIMS project, so you can see the level of detail expected. The names and system are illustrative; replace them with your own.

In this example the process owner is Accountable for eleven of sixteen deliverables, which is normal: the process owner owns the system in production. QA carries a second Accountable role on deviation disposition and the go-live decision, which is correct because release is a joint business-and-quality decision and the two accountabilities are for different aspects (fitness for use versus compliance), not a duplicate accountability for the same outcome.

Common inspection findings this matrix prevents

• No documented ownership, so when a deliverable is challenged nobody can say who was accountable for it, and the project team gives conflicting answers to the same investigator question.
• Two people both believing they were accountable for a deliverable, resulting in neither reviewing it fully.
• QA left off a deliverable’s row entirely, discovered only when the summary report is challenged for lacking an independent quality decision.
• The validation lead accountable for deliverables that should belong to the business or system owner, which reads as the vendor or consultant self-certifying its own work.

How to adapt this matrix

1. Set the project name, document number, and parent plan reference in the header.
2. Add or remove role columns to match your actual project team; a submission-linked system may need a regulatory affairs column, a data migration may need a data lead column.
3. Assign every cell before the plan is approved. An unassigned cell is not a placeholder to fill in later, it is an open risk.
4. Re-approve the matrix under change control whenever a role changes hands during the project.