ValidaPoint extends Microsoft 365 logging to meet GxP requirements
Native audit logging in Microsoft 365 lacks the immutability, cryptographic verification, and separation of duties that GxP auditors require.
ValidaPoint generates tamper-evident, chronological records of every document lifecycle event. Azure SQL ledger enforces data integrity at the storage layer. The audit trail is immutable from the point of capture, aligned to FDA 21 CFR Part 11 and EU GMP Annex 11..
Standard Logs Fail Regulatory Scrutiny
Why relying on existing IT systems leaves quality operations vulnerable during a rigorous regulatory or customer inspection.
Part 11 Non-Conformance
SharePoint version history is not a compliant quality record. Administrators can alter audit logs, and routine system updates overwrite historical metadata. This violates the record protection requirements of FDA 21 CFR Part 11.10(c).
Part 11 Non-Conformance
SharePoint version history is not a compliant quality record. Administrators can alter audit logs, and routine system updates overwrite historical metadata. This violates the record protection requirements of FDA 21 CFR Part 11.10(c).
Failed Non-Repudiation
Native timestamps lack cryptographic verification. Without an immutable record, digital signatures, document approvals, and batch record activities cannot be validated during audit.
Failed Non-Repudiation
Native timestamps lack cryptographic verification. Without an immutable record, digital signatures, document approvals, and batch record activities cannot be validated during audit.
Critical Regulatory Observations
Auditors require a verifiable history of every action. Mutable logs produce 483 observations, major non-conformances, and put approved supplier status at risk.
Critical Regulatory Observations
Auditors require a verifiable history of every action. Mutable logs produce 483 observations, major non-conformances, and put approved supplier status at risk.
Objective Evidence. A Validated State of Control.
ValidaPoint configures a centralised logging layer within Microsoft 365 that generates immutable audit records for every document lifecycle event.
Cryptographic Ledger Storage
The configuration writes all system logs to an Azure SQL ledger. Cryptographic hashing seals each event sequence. No entry can be modified after commit.
Log entries are cryptographically linked in sequence.
Write-once storage prevents modification, independent of user permissions.
The ledger is the single source of truth for all quality system activity.
Automated Event Capture
The system captures all user activity automatically. Every document event, metadata change, and approval action writes to the ledger without manual intervention.
Captures document uploads, state changes, and metadata modifications.
Captures workflow approvals across the full document lifecycle.
Captures Part 11-compliant electronic signature events automatically.
Independent Record Export
Audit records export independently of the source document. Each export produces a human-readable, chronological view of the full document history.
Export runs independently of the source document.
The export demonstrates chain-of-custody for any controlled document.
Structured, verifiable evidence available on demand.
ALCOA+ Data Integrity Controls
External auditors evaluate systems against ALCOA+ principles. ValidaPoint configures these controls natively within Microsoft 365.
Attributable
Role-based access controls link every action to an authenticated user identity.
Attributable
Role-based access controls link every action to an authenticated user identity.
Contemporaneous
Secure server clocks generate all timestamps independent of local machine time.
Original & Accurate
Write-once storage preserves each log entry exactly as it occurred.
Legible & Available
The full chronological record is searchable, readable, and exportable on demand.
Benchmark Your Microsoft 365 Audit Readiness
A five-minute assessment that benchmarks your current document workflows and version history against supplier audit expectations.
A short assessment to benchmark your current practices
against audit-ready expectations.
Quality System Data Isolation
The architecture isolates compliance data from unauthorised modification and IT-level vulnerabilities.
Separation of Duties
The configuration enforces role-based access control across all document libraries. Personnel access only the documents required by their job function. The ledger sits outside standard IT administrative permissions.
Granular Control Over
Quality System Data
The architecture isolates compliance data from unauthorised modification and IT-level vulnerabilities.
Separation of Duties
The configuration enforces role-based access control across all document libraries. Personnel access only the documents required by their job function. The ledger sits outside standard IT administrative permissions.
Regulatory Alignment
The configuration maps to the technical controls required by FDA 21 CFR Part 11 and EU GMP Annex 11.
FDA 21 CFR Part 11
21 CFR Part 11.10(e) requires computer-generated, timestamped audit trails that record the sequence of operator entries and field-level changes. ValidaPoint configures these controls natively within Azure SQL ledger, producing tamper-evident records without third-party SaaS dependencies.
EU GMP Annex 11
ISO 13485 & ISO 9001
Configuration Comparison
How ValidaPoint configuration compares with standard Microsoft 365 and enterprise QMS platforms.
Feature
Feature
System Record Storage
System Record Storage
Modification Risk
Implementation Time
Digital Signatures
Customer Audit
Ready
Log Integrity
Customer Audit
Ready
Auditor Readiness
Customer Audit
Ready
Standard Microsoft
365
Enterprise
QMS
SharePoint lists and version history
Large
pharma
manufacturers
Administrators can modify or delete audit logs
Administrators can modify or delete audit logs
Requires third-party SaaS licensing
Requires third-party SaaS licensing
Mutable record history
Mutable record history
Non-conformance risk during customer audits
Non-conformance risk during customer audits
ValidaPoint
Configuration
ValidaPoint
Configuration
Isolated Azure SQL ledger
Suppliers & small-mid
pharma
Suppliers &
small-mid
pharma
Tamper-evident, write-once record with separation of duties
Tamper-evident, write-once record with separation of duties
Native Part 11-compliant cryptographic verification
Native Part 11-compliant cryptographic verification
ALCOA+ aligned immutable audit trail
ALCOA+ aligned immutable audit trail
Audit-ready evidence on demand
Audit-ready evidence on demand
Validated Implementation Methodology
Validated Implementation Methodology
Full deployment from gap analysis through validated go-live, without disrupting ongoing operations.
Full deployment from gap analysis through validated go-live, without disrupting ongoing operations.
Phase 1: Discovery & Scope
Requirements gathering, gap analysis, and validation scope definition.
Phase 2: Configuration
Azure SQL ledger deployment, document library structuring, and automated workflow configuration.
Phase 3: System Validation
Pre-built IQ/OQ/PQ test script execution and QA-ready report generation.
Phase 4: Production Go-Live
End-user training and production deployment.
Assess Your Document Control Infrastructure
Identify compliance gaps in your current Microsoft 365 audit logs.
The assessment benchmarks your configuration against GxP audit trail requirements.
Assess Your Document Control Infrastructure
Identify compliance gaps in your current Microsoft 365 audit logs.
The assessment benchmarks your configuration against GxP audit trail requirements.
Need to Establish Audit-Ready Document Control?
Identify compliance gaps in your current Microsoft 365 audit logs.
The assessment benchmarks your configuration against GxP audit trail requirements.
Our Other Capabilities
Audit-Ready Document Control for Microsoft 365
ValidaPoint configures Microsoft 365 as a GxP-compliant document control system. Typical deployment: 8 weeks.