ValidaPoint configures Microsoft 365 to meet customer audit expectations across regulated industries. The configuration aligns with GMP and GDP audits from pharmaceutical and biotech customers, ISO 13485 audits from medical device manufacturers, ISO 9001, ISO 22000, and HACCP evaluations, supplier qualification and re-qualification audits, and technical quality agreement requirements.

The configuration addresses recurring audit findings directly. Document lifecycle controls prevent obsolete document use. Immutable audit trails generate structured historical evidence on demand.

Both. ValidaPoint serves regulated suppliers (packaging, logistics, technical services, laboratories, IT providers with GxP impact) who face high customer audit pressure without a quality system proportionate to their risk profile. It also serves small and mid-size life sciences manufacturers who need audit-defensible document control, electronic signatures, and audit trails without the cost or scope of enterprise platforms.

In both cases, the configuration sits inside the customer's existing Microsoft 365 tenant. Ownership and data residency stay with the organisation.

Enterprise QMS platforms target large pharmaceutical organisations with 20+ quality modules. For regulated suppliers, these platforms present four barriers. Annual licensing exceeds typical supplier quality budgets. The functional scope is built for pharma manufacturers, not supply chain partners. Validation requirements are disproportionate to supplier risk. Implementation timelines run six to eighteen months, incompatible with audit urgency.

ValidaPoint focuses on validated document control and training traceability. The focused scope produces faster implementation, lower cost, and proportionate validation against customer audit requirements.

No. Standard SharePoint Online requires additional controls to support GxP use. ValidaPoint configures four compliance layers inside the existing tenant: enforced lifecycle states that prevent unauthorised edits, tamper-evident audit trails stored in a separate immutable ledger, electronic signatures with cryptographic verification, and training effectiveness gates that bind acknowledgement to the current effective version.

The result is a configured system that meets FDA and EMA expectations for electronic records and signatures, built on infrastructure the organisation already owns.