Manage research documents.
Archive lab records.
Ensure compliance.
Pass every audit first time: Batch documentation, quality protocols and validation documents are fully versioned, completely traceable and FDA 21 CFR Part 11 compliant.
Do audits keep you up at night?
Regulatory Requirements
GMP, GLP, GDP, FDA, EMA - the regulatory requirements for documentation are enormous. Errors can cost approvals.
Audit Trail Required
Every change must be traceable. Who changed what and when? Inspectors expect complete documentation.
Batch Traceability
In case of quality issues, all documentation for a batch must be immediately available. No delay permitted.
Sensitive Research Data
Patents, formulations, research results - this data must not fall into the wrong hands.
How Docuflair supports your compliance
Complete Audit Trail
Docuflair logs every action: Create, modify, read, delete. Who, when, what - immutable and traceable.
More about ArchiveVersion Control
SOPs, test specifications, validation documents - always the current version available, complete change history.
More about FlowBatch Record
All documents for a batch in one place: Manufacturing protocols, test reports, releases. Instant access during recalls.
More about ScanOn-Premises Security
Research data and formulations remain on your infrastructure. No cloud, no risk for intellectual property.
33 Good ReasonsTypical pharma workflows with Docuflair
Batch Record Management
Batch documentation is captured during production and automatically assigned to the batch number. Releases are issued digitally.
- Complete batch documentation
- Digital release processes
- Immediate availability
SOP Management
Manage Standard Operating Procedures with version control. Changes go through defined approval processes with audit trail.
- Always current version
- Complete change history
- Integrated training acknowledgment
Validation Documentation
Centrally manage IQ, OQ, PQ protocols, validation reports and qualification documents. Audit-ready for inspections.
- All documents quickly searchable
- Audit-proof storage
- Inspection-ready
The most important modules for pharma
Docuflair Archive
Audit-proof archiving with complete audit trail.
Learn moreDocuflair Flow
Workflow automation and approval processes.
Learn moreDocuflair Scan
Digitise documents with OCR and classification.
Learn moreDocuflair Access Control
Role-based access control for sensitive data.
Learn moreWith Docuflair, we passed our FDA inspection without any findings. The complete audit trail and immediate access to all batch documentation convinced the inspectors.
Frequently Asked Questions
Answers to the most important questions about Docuflair for pharma & chemicals
How does Docuflair support regulatory compliance?
Docuflair provides a complete audit trail for all document actions, version control for SOPs and validation documents, and secure on-premises storage. The system supports GMP, GLP, GDP requirements and FDA 21 CFR Part 11 compliance.
Can Docuflair manage batch documentation?
Yes, With Docuflair, you manage batch records completely. All documents related to a batch are centrally stored: manufacturing protocols, test reports, release documentation. Immediate access during recalls or audits.
How is version control handled for SOPs?
Docuflair manages Standard Operating Procedures with full version control. Changes go through defined approval workflows with complete audit trail. You can integrate training acknowledgments.
Is research data secure with Docuflair?
Absolutely. Docuflair runs 100% on-premises on your infrastructure. Patents, formulations, and research results never leave your premises. No public-cloud dependency., no risk for intellectual property.
Does Docuflair support validation documentation?
Yes, Docuflair centrally manages IQ, OQ, PQ protocols, validation reports, and qualification documents. All documents are quickly searchable and stored in an audit-proof manner for inspections.
See how pharma companies meet their compliance requirements
See how Docuflair meets your regulatory requirements in a personal demo.