YEAR: 2022

Pharma icon

OVERVIEW

Digitizing processes for better organizational efficiency

A major player in the pharmaceutical industry approached InfoCert to rapidly implement digital signature processes. The client had the following needs:

  • Easy to use and flexible platform
  • Guaranteed legal validity of signatures
  • Ability to integrate the solution within existing enterprise systems
  • Ability to involve in the signature workflows users from outside the organization
  • Possibility to manage processes with different types of electronic signatures
  • Compliance with the industry regulations
  • Ability to verify time stamps and digital signatures of different stakeholders

CHALLENGE

Pharma and digital transformation: the importance of regulation

To meet these needs, the Client turned to InfoCert, strengthened not only by its wide range of Digital Trust solutions, but also by a team completely dedicated to the study and analysis of Compliance. In fact, the adoption of innovative and digital solutions in the Life Sciences sector requires compliance with industry regulations, such as CFR 21 part 11 of the FDA (Food and Drug Administration), which governs how pharmaceutical, biotechnology and scientific companies manage their electronic documents and signatures. This is why it is critical to turn to qualified providers who can integrate the security and efficiency of Digital Trust with compliance with current regulations.

SOLUTION

GoSign, the simple, flexible and secure signature solution

InfoCert thus supported the Client in choosing services that would meet the organizational needs and the general and specific regulatory constraints of the pharmaceutical sector. The solution proposed was GoSign, the platform able to create and manage signature approval workflows involving both internal and external users. Moreover, to facilitate the implementation, GoSign has been fully integrated within the management system already in use.

To ensure flexibility and regulatory compliance, GoSign allows the use of different types of signatures including password-enhanced simple signature. In addition, to enable the signature of users not belonging to the organization, a signatory user identification phase has been provided and documents are sent by password-protected e-mail.

Thanks to GoSign, the Client has been able to manage business needs in a simple and intuitive way and  to quickly engage different stakeholders in digital document management.