Controlled content
Document libraries, metadata, review and approval flows, versioning, retention, and access for controlled information.
GxP / Computerized system validation
SharePoint validation for regulated teams.
Practical, risk-based support to define how SharePoint is used, document what matters, test the right controls, and assemble reviewable evidence for your quality system.
Validation starts with intended use—not a generic checklist.
The scope, controls, and evidence should reflect business impact, data integrity, configuration, integrations, and your organization’s procedures.
Where support fits
SharePoint can support critical work in many forms.
We help teams examine the actual process and configuration before deciding what belongs in the validation boundary.
Forms and workflows
Configured forms, lists, approvals, notifications, and automations that support regulated business processes.
Records and evidence
Data capture, auditability, status history, electronic records, exports, and evidence used for review or decisions.
Connected systems
Permissions, identity, Power Platform components, interfaces, migration, and dependencies that can affect the validated process.
Validation deliverables
Clear documents, connected to risk and evidence.
Deliverables are selected and scaled according to the intended use, risk, project stage, and your quality procedures.
- Intended use and scopeDefine the business process, users, records, decisions, system boundary, dependencies, and regulated context.
- Validation planning and URSSet responsibilities and acceptance criteria, then express user needs in clear, testable requirements.
- Risk assessmentConnect functional and data-integrity risks to controls, test depth, and required evidence.
- IQ, OQ, and PQ—as appropriatePrepare and execute installation, operational, performance, or equivalent verification suited to the system and procedures.
- Traceability and objective evidenceLink requirements, risks, controls, tests, results, deviations, and supporting records in a reviewable chain.
- Reporting and change controlSummarize results, open items, and acceptance decisions, then define how validated configurations are maintained through change.
Risk-based approach
A practical path from context to maintained evidence.
The work can support a new implementation, a substantial change, or an assessment of an existing SharePoint environment.
Understand
Map the intended use, process, stakeholders, records, configuration, suppliers, and existing quality-system expectations.
Define
Set the boundary, requirements, responsibilities, risks, controls, acceptance criteria, and proportionate test strategy.
Verify
Execute approved testing, capture objective evidence, document deviations, and maintain traceability through review.
Maintain
Complete the report and establish practical change, access, incident, backup, review, and retirement controls as applicable.
MDose AI provides validation and documentation support; it does not certify systems or guarantee regulatory compliance. Final approval and accountability remain with the regulated organization.
Frequently asked questions
A clearer starting point for SharePoint validation.
Does every SharePoint use require validation?
No. The approach should follow the intended use, the records or decisions the system supports, applicable procedures, and documented risk. Scoping determines what needs control and evidence.
What can a SharePoint validation package include?
Depending on scope and risk, a package can include an intended-use statement, validation plan, URS, risk assessment, IQ/OQ/PQ or other appropriate testing, traceability, objective evidence, deviation records, and a summary report.
Are IQ, OQ, and PQ always required?
Not automatically. Test phases and terminology should suit the system, intended use, risk, hosting model, available supplier evidence, and your organization’s procedures.
Can existing SharePoint sites and workflows be assessed?
Yes. Existing configurations, permissions, workflows, records, integrations, and documentation can be reviewed to identify gaps and define a proportionate remediation and evidence plan.
Does MDose AI certify SharePoint as compliant?
No. MDose AI provides validation and documentation support. The regulated organization remains responsible for approving its intended use, procedures, risk acceptance, and validated state.
Start with the context
Discuss your SharePoint use, risk, and documentation needs.
Share what the system supports, where the project stands, and what your quality team needs to review.