Stop wrestling with SharePoint, shared drives, and ad-hoc file systems that can't pass an FDA inspection. CERF ELN is a purpose-built 21 CFR Part 11 and GLP-compliant document and file management platform for regulated laboratories — with true audit trails, PKI digital signatures, and ultra-long-term archiving built in from day one.
The Problem
Most regulated labs manage documents across a patchwork of tools that were never built for compliance. CERF consolidates them into a single auditable system.
Why Generic Tools Fail
Consumer and enterprise file management tools share a critical flaw: they were never designed with FDA inspections, GLP audits, or 21 CFR Part 11 requirements in mind. Here is what that costs regulated labs.
SharePoint logs can be deleted or altered by administrators. A compliant audit trail must be computer-generated, time-stamped, and impossible to modify from within the system — a foundational requirement of 21 CFR 11.10(e).
Clicking "approve" in SharePoint is not an electronic signature under 21 CFR Part 11. Compliant signatures must be unique, non-repudiable, and cryptographically linked to the signed record — not just a checkbox.
SharePoint version histories can be purged. GLP and 21 CFR Part 11 require that all previous versions of a record remain available for the life of the study — which for many organizations means indefinitely.
Validating SharePoint for 21 CFR Part 11 compliance is a notoriously complex and expensive undertaking. Most labs end up with a fragile system that drifts out of compliance with every Microsoft update.
Controlling access in SharePoint at the granular level required by GLP — where users in search results only see what they're specifically authorized to see — requires complex, brittle configuration that rarely holds.
When an FDA inspector asks for a complete, human-readable record of a study, SharePoint cannot generate it. CERF exports a complete, structured, digitally-signed record package on demand.
Platform Features
CERF combines the functions of an EDMS, ELN, SOP management system, and semantic file manager — all with the compliance infrastructure required by 21 CFR Part 11 and GLP.
Every action — file creation, edit, access, deletion attempt, signature event — is captured in a secure, computer-generated, time-stamped audit trail that cannot be modified or deleted from within the system. Fully exportable for regulatory inspection.
CERF is the only ELN that uses genuine Public Key Infrastructure (PKI) hashing — applying the U.S. federal government's Digital Signature Algorithm (DSA). Signatures are cryptographically linked to their records and cannot be transferred or falsified.
No version of any document is ever deleted in CERF. All previous versions, including deleted content, remain available for inspection. Changes are visible and the original entry is never obscured — a core requirement of 21 CFR 11.10(e).
Control access at the workgroup, project, folder, and individual record level. Unauthorized users cannot even see a record exists in search results — ensuring complete data confidentiality across concurrent studies and client projects.
CERF's search engine understands metadata, relationships between files, and the meaning of scientific content — not just filename keywords. Find anything in seconds across your entire archive, with results filtered by your access permissions.
Manage Standard Operating Procedures with full version control, approval workflows, and controlled distribution. Ensure your lab always works from the current approved version, with a complete history of every SOP revision and user acknowledgment.
CERF stores, indexes, and previews virtually any file type — raw instrument data, proprietary scientific formats, images, PDFs, spreadsheets, videos, DICOM, CML chemistry structures, biological sequence files, and more. Drag entire folder trees from your desktop directly into CERF.
CERF 6 extends the table tool to allow image thumbnails in table cells — enabling structured specimen registries, image grids, and visual data tables where each row contains a preview, metadata, and linked documents in a single auditable notebook entry.
CERF automatically extracts and indexes metadata from files at ingestion. Researchers can also add rich semantic annotations that carry forward for the lifetime of the record, ensuring future scientists can find and understand your data decades later.
Export complete notebooks, files, audit trails, signature records, and metadata packages as PDF or open-standard XML — ready for agency review, due diligence inspection, or data migration. The CERF Exporter handles bulk exports with a single operation.
Deploy CERF in the cloud, on-premise on your own servers, or on a completely sealed LAN with no internet connectivity required. Choose MySQL, MS SQL, or Oracle as your database backend. Available perpetual licensing means your data remains accessible forever.
Automatically capture files generated by lab instruments, desktop applications, and email attachments directly into CERF — maintaining the complete chain of custody for every data file from the moment of creation, with no manual transfer steps.
Head-to-Head
This comparison applies equally to Microsoft SharePoint, shared network drives, Google Drive, Dropbox, and other general-purpose file management tools.
| Compliance Requirement | CERF ELN | SharePoint / Generic Tools |
|---|---|---|
| Immutable, computer-generated audit trail (21 CFR 11.10(e)) | ✓ | ✗ |
| True PKI / DSA digital signatures | ✓ | ✗ |
| Signatures cryptographically linked to records (21 CFR 11.70) | ✓ | ✗ |
| Permanent version history — all versions retained indefinitely | ✓ | ~ Add-on required |
| Granular role-based access (search results respect permissions) | ✓ | ~ Complex config |
| SOP management with approval workflows | ✓ | ~ Add-on required |
| Automated metadata extraction and semantic annotation | ✓ | ✗ |
| IQ / OQ validation support and documentation | ✓ | ✗ |
| Sealed LAN deployment (no internet required) | ✓ | ✗ |
| Inspection-ready PDF and XML record exports | ✓ | ~ Manual / partial |
| Electronic lab notebook integrated with document management | ✓ | ✗ |
| Perpetual license — data accessible after subscription ends | ✓ | ✗ |
| Designed for 21 CFR Part 11 and GLP from the ground up | ✓ | ✗ |
Who Uses CERF
CERF is trusted as a compliant document management system across a wide range of regulated industries and laboratory types.
Manage pre-clinical study records, regulatory submission files, SOPs, and IP documentation in a single 21 CFR Part 11 compliant system — ready for FDA inspection at any time.
Manage whole slide images, tissue specimen metadata, staining SOPs, and peer review sign-off in a single compliant system — with CERF 6's purpose-built histology workflows.
Manage concurrent, multi-client studies with complete data isolation. Give sponsors secure access to their data while keeping all other client records fully confidential.
Maintain design history files, risk documentation, and verification records in a compliant repository supporting 510(k) and PMA submissions.
Store study plans, raw data, and final reports in a GLP-compliant system that meets OECD and EPA requirements for environmental safety data.
Protect intellectual property, support patent applications, and maintain FAIR-compliant research data with permanent, auditable records that establish clear provenance.
Common Questions
Common questions about laboratory document management and CERF.
Talk to a CERF specialist about your organization's document management requirements. We'll show you exactly how CERF addresses your compliance needs, deployment constraints, and workflow — no generic demos.