eSignature Software for Pharma and Life Sciences Organizations
Meet FDA electronic signature requirements. Maintain GxP compliance. Keep your document control moving.
Life Sciences Signing Demands More Than Standard eSignatures.
FDA 21 CFR Part 11 establishes specific requirements for electronic records and signatures in regulated environments: unique user identification, non-repudiation, audit trails, and controls that ensure signed records cannot be altered without detection. Inkfree's life sciences eSignature platform provides the compliance infrastructure for commercial agreements, quality documentation, and clinical paperwork that regulated organizations rely on. Please note: Inkfree is not currently validated for GxP use under 21 CFR Part 11 for batch records or QMS sign-offs. It is suitable for commercial agreements, HR documents, clinical trial commercial paperwork, and non-regulated administrative workflows.
Every Life Sciences Organization That Signs Regulated Documents
From pharmaceutical companies to CROs and CMOs, Inkfree supports the document signing workflows that regulated life sciences organizations depend on.
Pharmaceutical Companies
Execute GxP-adjacent documents: commercial agreements, clinical trial contracts, vendor qualification records, and regulatory correspondence with a compliant signing platform and full audit trail.
Inkfree provides a compliant audit trail for every commercial and clinical agreement.
Biotech and Biologic Manufacturers
Manage IND-stage and commercial-stage document control with a platform that scales from early-phase research agreement signing to full commercial operational document workflows.
Inkfree scales document control from early research through full commercial operations.
Medical Device Manufacturers
Meet documentation requirements for design control, supplier qualification, and product release with a digital signing platform that captures electronic signatures with defined signing sequences.
Inkfree captures defined signing sequences for every regulatory documentation event.
Contract Research Organizations (CROs)
Execute clinical trial agreements, site initiation documents, informed consent forms, and protocol amendments with sponsor organizations using a compliant, audit-ready eSignature platform.
Inkfree keeps clinical trial agreements moving between sponsors and sites efficiently.
Contract Manufacturing Organizations (CMOs)
Sign quality agreements, batch release authorizations, and vendor qualification records with pharmaceutical clients using a platform that satisfies their QMS documentation requirements.
Inkfree satisfies pharmaceutical client QMS requirements on every quality document.
Every Life Sciences Organization That Signs Regulated Documents
From pharmaceutical companies to CROs and CMOs, Inkfree supports the document signing workflows that regulated life sciences organizations depend on.
Pharmaceutical Companies
Execute GxP-adjacent documents: commercial agreements, clinical trial contracts, vendor qualification records, and regulatory correspondence with a compliant signing platform and full audit trail.
Inkfree provides a compliant audit trail for every commercial and clinical agreement.
Biotech and Biologic Manufacturers
Manage IND-stage and commercial-stage document control with a platform that scales from early-phase research agreement signing to full commercial operational document workflows.
Inkfree scales document control from early research through full commercial operations.
Medical Device Manufacturers
Meet documentation requirements for design control, supplier qualification, and product release with a digital signing platform that captures electronic signatures with defined signing sequences.
Inkfree captures defined signing sequences for every regulatory documentation event.
Contract Research Organizations (CROs)
Execute clinical trial agreements, site initiation documents, informed consent forms, and protocol amendments with sponsor organizations using a compliant, audit-ready eSignature platform.
Inkfree keeps clinical trial agreements moving between sponsors and sites efficiently.
Contract Manufacturing Organizations (CMOs)
Sign quality agreements, batch release authorizations, and vendor qualification records with pharmaceutical clients using a platform that satisfies their QMS documentation requirements.
Inkfree satisfies pharmaceutical client QMS requirements on every quality document.
Life Sciences Documents Inkfree Handles Every Day
From SOPs and clinical agreements to regulatory correspondence and supplier contracts, Inkfree covers every regulated document workflow.
SOP and Work Instruction Acknowledgments
Distribute updated SOPs and collect digital acknowledgments with unique user ID, signature meaning, and timestamp. Archive every signed record with a full audit trail.
Electronic Batch Record Sign-Off
Route batch manufacturing records through production, quality control, and quality assurance, each signature documented, timestamped, and linked to the signatory's credentials.
CAPA and Deviation Documentation
Route CAPA and deviation records through investigation, root cause analysis, and effectiveness review stages in sequence, with a complete, auditable approval record at every step.
Clinical Trial Informed Consent
IRB-approved informed consent forms require documented patient signatures with clear evidence of when consent was obtained. Inkfree's audit trail provides this evidence for clinical trial master files.
Vendor and Supplier Quality Agreements
Execute quality agreements, approved supplier qualifications, and technical service agreements with CROs, CMOs, and materials suppliers, documented to your QMS standard.
Regulatory Submission Correspondence
Sign cover letters, response documents, and commitment letters for regulatory submissions with authorized signatory credentials captured in a compliant audit trail.
Globally Recognized Compliance.
Every document is encrypted, legally valid, and compliant anywhere in the world.
AES-256 Encryption
Every document encrypted in transit and at rest.
ESIGN, UETA & eIDAS
Legally valid in the US, EU, and 180+ countries.
Tamper-Proof Audit Trail
Every action logged and included in the Certificate of Completion.
Two-Factor Authentication
Secure account access with 2FA enforced for all users.
Global Legal Validity
Signatures recognized and enforceable worldwide.
Secure Cloud Storage
Documents archived securely and accessible at any time.
Life sciences organizations that adopt digital signature workflows can reduce agreement turnaround times by up to 40% and significantly improve data integrity across their regulated document processes.
Life Sciences Features That Matter
- OTP and Passcode Authentication
- Legally Binding Digital Audit Trail
- Signing Order
- Approval Workflows
- Manage Roles and Permissions
- Unlimited Document Storage
- Templates and Folder Organization
- Renewal Notifications and Automatic Expirations
- Reporting
- Multi-Document Envelopes
Manage Regulated Documents in Three Simple Steps
Inkfree fits into existing workflows with no complex setup. Most teams send their first document within minutes.
Questions, answered.Questions Answered About eSignatures for Life Sciences
Yes. Inkfree is compliant with the U.S. ESIGN Act and UETA, making documents legally binding across all adopting U.S. states. For international use, Inkfree is also eIDAS compliant. This applies to licensing agreements, partnership contracts, supplier agreements, and other commercial documents.
Inkfree is not currently validated for GxP use or compliant with 21 CFR Part 11. It is suitable for commercial agreements, HR documents, and non-regulated administrative workflows. For GxP-regulated documents, please consult your quality and compliance team.
Inkfree's signing order and multi-document envelope features support complex, multi-party signing processes, allowing documents to move through the right signatories at the right sites in the correct sequence.
Inkfree supports identity verification via email access, OTP authentication, passcode authentication, and optional two-factor authentication, providing multiple layers of verification before any document is signed.
Inkfree provides unlimited document storage so all signed documents are retained without time limits or additional storage costs.
Compliant Signing for Life Sciences - From Agreement to Archive
Inkfree gives life sciences organizations the eSignature infrastructure to execute commercial agreements, quality documentation, and clinical paperwork with confidence, backed by the audit trail that protects you in every review and inspection.