Validating a SharePoint Quality Register: A Worked Example

This is a companion piece to Beyond Excel: A Practical GxP Approach to Quality Registers Using SharePoint Lists, working through what validating a SharePoint deviation register actually looks like once the record-versus-register boundary is settled. This is a proposed risk-based approach — the final validation strategy should be appropriate to the organisation's own procedures, regulatory context, and intended use.

What is being validated

A SharePoint List configured as a deviation register, where the paper system remains the authoritative GMP record. The paper record stays responsible for the deviation and investigation narrative, root-cause analysis, impact and risk assessment, investigation approval, and signatures and supporting evidence. The SharePoint List supports identification and status tracking, ownership and due-date monitoring, risk categorisation, root-cause trending, and resource prioritisation.

Six core deliverables

1. User requirements specification. Define intended use, required functions, users, data, and boundaries — describing what the organisation needs, not every capability SharePoint offers. Requirements should concentrate on intended use, critical data, access, traceability to the paper record, and reporting reliability, not on low-value platform features included merely to pad the document.

2. Functional risk assessment. Identify credible failure scenarios and whether existing or proposed controls reduce risk to an acceptable level: incorrect classification affecting trend reports; a missing record reducing visibility of a quality event; incorrect status showing a deviation as closed while the paper process remains open; unauthorised modification of classification or status; lost traceability between the electronic entry and its paper file; and incorrect report output from flawed filters or dashboard logic. The paper source reduces some risks but does not eliminate risks relating to trending, oversight, timeliness, or resource allocation.

3. Configuration specification. Document the controlled configuration implementing the approved requirements and risk controls — field types, required status, and controlled choice values for status, risk category, and deviation type — with screenshots supporting, not replacing, a clear, reviewable specification. Any Power Automate or Power BI connections should be documented here too.

4. Validation plan. Define how assurance will be established and how the package scales to the solution's risk, complexity, and novelty. In scope: the register configuration, critical data fields and classifications, permissions and version history, reporting outputs used for quality decisions, and register-to-paper traceability. Excluded or leveraged: Microsoft's own software-development processes, physical data-centre qualification, and generic testing of standard SharePoint functions unrelated to intended use. "Do not re-test Microsoft" does not mean Microsoft is automatically compliant — the organisation remains responsible for its own configuration, data, access model, and reliance decisions.

5. Verification protocol and evidence. Test that a deviation can be created with all mandatory information, that saving without a required field is prevented, that only approved risk and root-cause values can be selected, that status history is retained after an update, that access control correctly distinguishes editors from read-only users, that an electronic entry can be traced to its paper deviation, and that a report or dashboard sample matches the underlying list data. Attention should concentrate on critical classifications, access controls, traceability, and decision-supporting reports — not on exhaustively exercising every SharePoint feature.

6. Validation summary report. Summarise completed evidence and the documented basis for release — intended use confirmed, requirements verified, risk controls tested, configuration baseline approved, and any residual risk accepted by authorised stakeholders — referencing detailed evidence rather than repeating every requirement or test step in full. Bulk does not equate to rigour.

Why the first register costs more than the next one

The first implementation establishes reusable assets: validation templates, list-design standards, permission groups, a risk-assessment model, a standard test library, and operational procedures. A subsequent register — a CAPA register, for example — reuses that framework but still needs its own process-specific assessment: the CAPA-specific intended use, source and ownership, effectiveness-check requirements, and process-specific risk and verification. Reuse is justified where the platform, governance, controls, and verification methods remain equivalent; a new assessment is required wherever the process, data, reports, or quality decisions genuinely differ.

When the lightweight approach is no longer enough

Risk is determined by intended use and reliance, not by the product name. Reassess the approach when a solution introduces electronic approval of GMP records or electronic signatures, complete electronic investigations, automated risk classification or product-impact decisions, complex workflow branching or custom code, system-to-system integration, or replacement of the paper source record. Any of those conditions warrant a more extensive validation strategy than the lightweight register approach described here.

The principle underneath it all

The goal is not to prove SharePoint works — it is to demonstrate that the organisation's configured register, supporting processes, and controls provide reliable information for their defined GxP use. Scale the documentation to the risk, complexity, and novelty of the intended use, and the validation package earns its credibility on decision quality, not on volume.