To showcase the real value of our new electronic signature feature for Certificates of Conformity (CoC), we invite you to step into the shoes of Clara, a Quality Manager at a biotech company.
Through her daily routine, we'll walk through the entire CoC management workflow and discover how this new functionality transforms a critical (yet often time-consuming) task into a smooth, secure, and fully traceable process.
A Seamless Quality Workflow
Clara starts her day by opening Smart Biotech. The quality checks for the produced batches have already been validated in the integrated LIMS. With a single click, she automatically generates the corresponding Certificate of Conformity: all analytical data, specifications, and results are pulled in without error, directly from the lab records.
No more copy-pasting or reformatting tables. Within seconds, the document is ready.
Security and Compliance at the Core
Clara selects the recipients and initiates the electronic signature process directly from the Smart Biotech interface, using the Odoo Sign module. The HSE Manager receives a notification, authenticates via SMS or ItsMe, and signs the document. It is now sealed, timestamped, and version-controlled. 🔐
It can no longer be altered or deleted: each signed version is preserved in the quality history. A traceability requirement fully met, with no extra handling needed.
One Document, One Proof, One Less Worry
For Clara, this change is not just technical—it’s operational relief. No more chasing down signatures. No more printing, scanning, or archiving paper documents. Each signed certificate becomes an official part of the quality system, instantly accessible, fully traceable, and always up to date.
And soon, this feature will be extended to quality control reports themselves, further strengthening the overall document integrity of the process.
A Major Step Forward in Quality Digitalization
The electronic signing of CoCs in Smart Biotech marks a significant milestone: one where compliance (especially with GxP requirements) no longer slows teams down but instead supports them—smoothly, securely, and efficiently.
This is the spirit of Smart Biotech: tools designed for real-world operations, serving both regulatory compliance and industrial performance.
✅ Are you a Quality Manager, CIO, or Regulatory Compliance Officer?
Our digitalization experts are here to help you:
- Navigate best practices for digital transformation,
- Assess your current processes and identify automation opportunities,
- Guide you in fully integrating electronic signatures into your quality workflows.
ℹ️ Glossary
- CoC (Certificate of Conformity): Official document confirming that a batch or product meets established quality specifications.
- LIMS (Laboratory Information Management System): Software that manages lab data and workflows.
- GxP: Set of good practice regulations (e.g., GMP, GLP) governing quality in the pharmaceutical/biotech industry.
Contact us for tailored support—and let’s turn your compliance into a strategic asset.
A Day with a Quality Manager in Biotechnology: Electronically Signed Certificates of Conformity