For Pharma & Chemicals

Manage research documents.
Archive lab records.
Ensure compliance.

Docuflair supports pharmaceutical and chemical companies with regulatory documentation: Batch documentation, quality protocols, validation documents - all versioned, audit-ready and FDA 21 CFR Part 11 compliant.

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100% On-Premises GDPR-compliant Compliant
Docuflair for Pharma & Chemicals - Regulatory Document Management
The Challenge

Do you recognise these problems?

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.

The Solution

How Docuflair supports your compliance

Complete Audit Trail

Every action is logged: Create, modify, read, delete. Who, when, what - immutable and traceable.

More about Archive

Version Control

SOPs, test specifications, validation documents - always the current version available, complete change history.

More about Flow

Batch Record

All documents for a batch in one place: Manufacturing protocols, test reports, releases. Instant access during recalls.

More about Scan

On-Premises Security

Research data and formulations remain on your infrastructure. No cloud, no risk for intellectual property.

33 Good Reasons
Use Cases

Typical pharma workflows with Docuflair

01

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
02

SOP Management

Standard Operating Procedures are managed with version control. Changes go through defined approval processes with audit trail.

  • Always current version
  • Complete change history
  • Integrated training acknowledgment
03

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
Recommended Modules

The most important modules for pharma

Docuflair Archive

Audit-proof archiving with complete audit trail.

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Docuflair Flow

Workflow automation and approval processes.

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Docuflair Scan

Digitise documents with OCR and classification.

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Docuflair Access Control

Role-based access control for sensitive data.

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100%
Audit Trail
0
Documentation Gaps
100%
On-Premises
∞
Batches Archivable
With Docuflair, we passed our FDA inspection without any findings. The complete audit trail and immediate access to all batch documentation convinced the inspectors.
Pharmaceutical Manufacturer Quality Assurance, 500 employees
Frequently Asked Questions

FAQ for Pharma & Chemicals

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.

Yes, Docuflair enables complete batch record management. All documents related to a batch are centrally stored: manufacturing protocols, test reports, release documentation. Immediate access during recalls or audits.

Standard Operating Procedures are managed with full version control. Changes go through defined approval workflows with complete audit trail. Training acknowledgments can be integrated.

Absolutely. Docuflair runs 100% on-premises on your infrastructure. Patents, formulations, and research results never leave your premises. No cloud dependency, no risk for intellectual property.

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.

Ready for compliance-ready documentation?

Experience in a personal demo how Docuflair meets your regulatory requirements.

Request Pharma Demo +43 3112 47853