A project team has a long list of ERP screens to test and limited time before go-live. Treating every screen as equally important may appear fair, but a report-formatting issue and an incorrect material-status decision can have very different consequences.

A risk-based discussion starts with intended use and the effect of failure. It helps the customer’s quality and process owners decide where stronger evidence is needed.

Begin with the decision the function supports

Describe each relevant function in business terms. Does it identify material, calculate a quantity, restrict an activity, preserve an electronic record or support a quality decision? What happens if its result is wrong or unavailable?

Health Canada’s Annex 11 guidance for computerized systems connects lifecycle risk management with patient safety, product quality and data integrity. It also calls for justified, documented risk assessment when determining validation and data-integrity controls. These are useful reference principles; applicability to an Indian site must be established by its quality team against its own obligations and markets.

Use concrete scenarios rather than labels alone

The following are illustrative assessment questions, not predetermined risk ratings:

• Material status: could a transaction use material that the process should exclude?
• Quantity conversion: could a conversion error affect dispensing or reconciliation?
• Access: could a user perform an action outside the approved role?
• Record correction: could a change obscure the original entry or its context?
• Interface retry: could a repeated message duplicate a consequential transaction?

Discuss the potential impact, circumstances of failure and the controls that would prevent or reveal it. Document the rationale rather than assigning a number and assuming the work is complete.

Do not assume detectability

A control is useful only if it exists, operates at the right point and has an owner. “QA will notice” is not a complete detection mechanism.

Specify what the reviewer sees, when the check occurs and what happens after a discrepancy is found. Confirm the proposed control through testing where appropriate. Risk scoring conventions, including the direction of detectability scales, should be defined consistently by the organisation.

Test failure paths and system boundaries

For important functions, include inappropriate inputs, unauthorised actions and interrupted workflows. Where an ERP exchanges records with another application, examine missing messages, duplicates and conflicting statuses.

A successful screen submission does not establish that the entire process is reliable. The evidence should address the function in its configured environment and intended workflow.

Keep testing, acceptance and validation distinct

Developer tests, customer user-acceptance testing and validation activities can contribute different evidence. Passing a demonstration or UAT session does not automatically establish a validated state.

Agree requirements, acceptance criteria, evidence ownership, deviation handling and the decision to permit operational use. The extent and formality should follow the documented assessment and applicable quality procedures.

Be precise about CSV and CSA references

FDA’s February 2026 computer software assurance guidance concerns software used in medical-device production or quality management systems. It should not be presented as a blanket replacement for pharmaceutical computerized-system validation.

For a pharma project, ask QA to identify the applicable framework and approve the approach. This article offers assessment questions, not a universal regulatory method.

Use Pharma Protocol workflows to make testing concrete

A feature checklist becomes more useful when it is tested against the plant’s actual decisions. For Pharma Protocol, the relevant discussion spans material control, QC and QA, production records, approvals and system connections.

Test who may act

Role-based access and electronic approval requirements should be demonstrated using the proposed users and responsibilities. Try the action with an authorised user and an inappropriate role; confirm the behaviour against your approved requirement.

Test what the record preserves

Audit-trail requirements should be assessed with a representative correction. Check the available record of the change and the reviewer’s ability to interpret it. A feature labelled “audit trail” should lead to visible acceptance evidence, not end the evaluation.

Test the handoff between functions

Follow a material or batch decision across the agreed stores, quality and production workflow. Where another system is involved, include failed or repeated updates in the integration test scope. Required controls and evidence must be assessed for the specific version and implementation.

A useful discussion: bring three decisions whose failure would matter most to your plant. We can help map the related software functions and implementation tests; your quality team retains responsibility for the applicable validation assessment and acceptance.

Neurons Software Consultants has served pharmaceutical customers for 23 years, with installations across 45+ formulation and bulk-drug manufacturers. Our implementation discussions connect software requirements with the way production, stores, quality and IT teams work.

Explore Pharma Protocol pharmaceutical ERP and read customer and vendor validation responsibilities. To discuss a scoped implementation and its testing needs, discuss your requirements with Neurons.

Sources

• Health Canada: Annex 11, Computerized Systems — risk-management reference principles.
• FDA: Computer Software Assurance for Production and Quality Management System Software — medical-device guidance scope.

Related guides

Vendor and Customer Onboarding: From Registration to ERP Master Creation
Delivered, Rejected or Partly Accepted? Closing the Delivery Reconciliation Gap
Before Moving to eBMR: Are Your Masters, BOMs and Manufacturing Stages Ready?
ERP, MES and eBMR: Which Manufacturing Problem Does Each Address?
Why a Single-Level BOM May Not Be Enough for Multi-Stage Pharma Manufacturing
Pharma ERP Validation: What Should the Customer and Software Vendor Each Prepare?