Digital Signatures for Part 11 Compliance

With digital signatures it is possible to fulfill all FDA requirements from 21 CFR Part 11 for Electronic Signatures, Closed/Open Systems, Signature Manifestations or Signature/Record Linking. The use of interoperable document and signature formats like PDF is important, here.

Your solution for Part 11 with PDF signatures

Secardeo assists you during analysis, conception, and realization of your solution for implementing Part 11. The basis for such a solution with PDF signatures can be provided by the pdfGate platform which we can integrate with your IT infrastructure. This allows Part 11 compliant processes within your DMS or workflow system.

Secardeo offers you excellent technical competence and implementation experience in the fields of PDF signatures und 21 CFR Part 11:

• Workshops about Part 11 / Electronic Signatures,
• Analysis of existing systems and specification of requirements compliant with Part 11,
• Conception and realization of Part 11 compliant solutions for digital signatures based on standards like PDF,
• Integration of our pdfGate platform for verifiable signature workflows,
• Realization of a company PKI or integration of an external trust center for Part 11 compliance.