The ERP is installed and a demonstration has been completed. Then a question arrives: “Will the vendor provide validation?” Different people may interpret that as test scripts, a documentation pack, execution support or a complete site-specific approval process.

Leaving the meaning unresolved until go-live creates avoidable uncertainty. Define the work, evidence and decision owners while agreeing the implementation scope.

Start with intended use and applicability

List the processes and records that the ERP will support. Identify the relevant sites, users, interfaces, data migration and operating environment. The customer’s quality team should establish the applicable requirements for the site and the markets it serves.

Health Canada’s Annex 11 guidance is one useful international reference for computerized systems in GMP activities. It addresses risk management, defined responsibilities, supplier arrangements and validation. Its Canadian context should not be mistaken for a statement of Indian legal requirements.

Agree a practical responsibility matrix

The following is a starting point for discussion, not a universal allocation or a promise of included Neurons deliverables.

• Intended use and user requirements: customer process owners define the needs; the vendor clarifies software behaviour and feasibility.
• Risk assessment: customer quality and process owners lead the assessment with relevant technical input from the vendor and IT.
• System definition: the vendor describes the agreed configuration and interfaces; the customer confirms the operational context.
• Test preparation and execution: allocate authorship, review, execution and evidence retention explicitly in the project agreement.
• Deviations and corrections: the vendor investigates software issues within scope; the customer determines quality impact and acceptance through its procedures.
• Operational approval: the customer’s authorised owners decide when the system may be relied upon.

Ask what supplier evidence is actually available

Discuss the software version, relevant specifications, test evidence, release information, known limitations and support arrangements. Where documents will be supplied, agree their scope, format and availability.

Supplier evidence may contribute to the customer’s assessment. It does not establish that every local configuration, migrated record and operating procedure has been assessed. Avoid relying on an unspecified “validation pack” as a complete answer.

Include the environment and connected systems

An ERP project may depend on infrastructure, authentication, backups, printers, interfaces and other applications. Determine which parties provide and verify each dependency.

Define checks for migrated data and the treatment of historical records. For interfaces, include missing or repeated updates and reconciliation of important statuses. The approved scope should make these boundaries visible.

Separate UAT from the approval to operate

User-acceptance testing helps establish whether the agreed workflow meets users’ needs. Validation considers evidence for intended use within the applicable quality framework. Activities can share evidence when appropriately planned, but the names are not interchangeable.

Agree how requirements connect to acceptance evidence, how deviations are assessed and which unresolved items prevent operational use. Define training and procedures before asking users to depend on the new process.

Plan the period after go-live

Clarify change assessment, access review, incident handling, backup and recovery responsibilities, and periodic evaluation as applicable. A release that changes an important function may need impact assessment and additional evidence.

Support arrangements should explain how the customer learns about changes and how authorised changes reach the live environment.

Bring clear inputs to the first discussion

Prepare the intended process scope, key records, relevant quality procedures, proposed users, interface list and target environment. Ask the vendor to identify what is standard, configurable, developed or excluded, and what validation support is included or separately scoped.

What this means when evaluating Pharma Protocol

Neurons’ Pharma Protocol scope includes pharmaceutical operations and controls such as role-based access, audit trails and electronic approvals. Those capabilities give the customer concrete functions to assess; they do not make a configured installation automatically validated.

Connect each requirement to a demonstrated feature

For an approval requirement, show the responsible user, permitted action and resulting record. For material traceability, follow the relevant inputs and outputs. For an audit-trail requirement, inspect a representative change. Agree acceptance criteria with the customer’s quality and process owners.

Identify the implementation boundaries

Document the version, configuration, custom work, migrated data and interfaces relevant to the customer’s intended use. ERP, LIMS and instrument connections should have defined owners and test responsibilities. Cloud or on-premise deployment also requires agreement on the operating environment and support boundary.

Specify validation support in the proposal

Ask Neurons to identify the documentation and assistance included in the agreed engagement, with exclusions and dependencies made explicit. Do not infer that script authorship, execution, infrastructure qualification or a complete validation package is included merely because the product supports compliance-related controls.

A useful starting point: bring your intended process scope and validation expectations. We can map product features, implementation deliverables and customer responsibilities into a reviewable scope before go-live planning.

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.

See Pharma Protocol pharmaceutical ERP and our article on risk-based ERP testing. To establish implementation responsibilities and documentation scope, discuss your requirements with Neurons. Software features support customer controls; neither an installation nor a generic document pack guarantees compliance.

Reference

Health Canada: Annex 11, Computerized Systems. The responsibility allocation above is Neurons’ recommended project discussion framework, not a regulatory checklist.

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