E-signature for pharma, biotech and medical devices
Pharmaceutical laboratories, biotech, medical device manufacturers, CROs (Contract Research Organisations), clinical trial sponsors: sign protocols, CRO/CMO contracts, informed consents and regulatory dossiers online. 21 CFR Part 11, GxP (GCP, GMP, GLP), ICH-E6 R2 and EU regulation 536/2014 (CTR) compliant.
Pharma regulatory requirements
Frequent ANSM, FDA and EMA audits, GxP traceability of documented decisions, mandatory signature by principal investigators, multi-country CRO contracts, informed consents in 12 languages: paper signatures expose you to audit findings (FDA Form 483, ANSM inspection letter) and to product approval delays. Certyneo provides the building blocks a signature system has to bring under 21 CFR Part 11 — signer identification, timestamping, a tamper-evident audit trail, sealing — on the understanding that compliance is assessed on your whole process: the FDA certifies no vendor.
FDA/ANSM audit gaps threaten paper signatures
Incomplete GxP traceability exposes to inspection observations (Form 483, ANSM letter). 21 CFR Part 11 compliant signature documents each decision in a verifiable way.
Clinical trial investigator signatures are scattered
Collecting multi-site principal investigator signatures on paper slows studies. Compliant remote signature accelerates enrollment without compromising compliance.
Multi-country CRO contracts delay product approval
Multilingual CRO contracts and consents pile up delays. Compliant electronic contracting reduces delays marking approval timelines.
Your regulatory documents online
6 use cases covering clinical development, manufacturing and product registration.
Clinical trial protocol
Protocol + amendments signed by sponsor, principal investigator and ethics committee. Native versioning, ICH-E6 R2 §5.5 traceability (Electronic Trial Master File).
Patient informed consent
ICF (Informed Consent Form) translated in 12+ languages, signed by patient and investigator. GDPR art. 9 (health data), Belmont Report and Helsinki Declaration compliant.
CRO / CMO contract
CRO Master Service Agreement, work order, SOW (Statement of Work), CMO/CDMO manufacturing contract. Multi-language, 21 CFR Part 11-compliant audit trail.
Material Transfer Agreement (MTA)
Biological sample transfer between research institutions, biological material transfer agreement compliant with NIH Uniform Biological MTA.
MAA / ANSM / FDA dossier
Common Technical Document (CTD) modules 1-5, variation dossier, IND (Investigational New Drug), CTA (EMA Clinical Trial Application): qualified signature + RFC 3161 timestamping.
Pharmacovigilance notification
Periodic Safety Update Report (PSUR), DSUR (Development Safety Update Report), serious adverse event (SAE) notification: signature with ICSR (Individual Case Safety Report) traceability.
Why Certyneo for pharma
21 CFR Part 11 compliant (FDA)
E-signature recognised by the FDA for IND, NDA, BLA submissions. Tamper-proof audit trail, unique signer identification, access control, manipulation-resistant timestamp sequence.
GxP & ICH-E6 R2
GCP (Good Clinical Practice), GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice): all ICH guidelines applicable to electronic TMF / DMS are supported.
12+ languages for clinical trials
ICF translated and signed in 12+ languages (EN, FR, DE, ES, IT, PT, NL, PL, JA, ZH, AR, RU). Independent versioning per language, native regulatory traceability.
Frequently asked questions — life sciences
- Is Certyneo 21 CFR Part 11 compliant?
- Yes. Our tamper-proof audit-trail architecture, role-based access control, manipulation-resistant timestamp sequence and unique signer identification (login + 2FA + optional biometry) satisfy the requirements of 21 CFR Part 11 Subpart B (Electronic Signatures). We provide a 21 CFR Part 11 compliance attestation within 48h.
- Is e-signature accepted by the ANSM for clinical trials?
- Since 31 January 2023, the ANSM requires every new clinical trial application to be filed in CTIS, the European portal created by Regulation (EU) No 536/2014, which has applied since 31 January 2022. The dossier is submitted there under the sponsor's own account, and the ANSM publishes no required eIDAS signature level for the documents that accompany it. Certyneo is for the deeds you sign among yourselves upstream: protocol, CRO contracts, delegation-of-duties logs, principal investigator's commitment.
- Can patient informed consent be signed electronically?
- Yes, and France has had a written framework for it since 26 June 2026. In the United States, the FDA and OHRP published a joint guidance on 15 December 2016, "Use of Electronic Informed Consent: Questions and Answers". In France, the Ministry of Health publishes its "Recommandations relatives à la délivrance d'information et au recueil du consentement dématérialisés des personnes se prêtant à des recherches". They set out the four eIDAS levels and recommend, for a person with capacity — on site as well as remotely — an advanced signature confirmed by an SMS code sent to a registered number tied to the signatory's identity. The qualified level is kept for the most exposed cases, such as the second holder of parental authority consenting for a minor without a video call. The sponsor sets out its arrangement in the research project so that the ethics committee (CPP) can check it.
- What is the audit-trail retention period?
- Our audit trail is retained for 30 years (recommended duration for clinical trials) or for the residual patent life of the drug (up to 50 years for some orphan drugs). The digital vault is NF Z42-013 qualified and SAE compliant with NF Z42-020.
- Is Certyneo ISO 27001 and ISO 13485 certified?
- Not yet for ISO 27001: the certification audit is in progress, and we will display the certification once the certificate has been issued. Data is hosted in the European Union, on our own infrastructure (IONOS). ISO 13485 (medical devices) does not apply to a signature SaaS vendor, but our 21 CFR Part 11 + GxP compliance is sufficient for software medical device manufacturers.
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