WEBINAR ON-DEMAND

How to Fast Track 21 CFR Part 11 Electronic Signatures in Adobe Sign

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Gianna DeRubertis

Director, Professional Services | Montrium

Gianna is the Director of the Professional Services team and is responsible for in-house verification projects as well as validation services provided to external clients. She has extensive validation experience, which includes validation of manufacturing equipment, utilities, and computerized systems (including ERP, EDMS, and eSignature solutions). Gianna has also developed a solid understanding of the various regulations which apply to the pharmaceutical, biotech and device industries.

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Jayashree Ramakrishna

Strategic Business Development Manager, Document Cloud | Adobe

Jay is part of the Document Cloud Strategic Business Development Team, working with Adobe's customers to drive collaboration around product innovation roadmap and identifying thought leadership opportunities around the digital transformation.

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Lorie Groth

Senior PMM, Adobe Sign Enterprise | Adobe

With over 25 years’ experience in enterprise software, Lorie helps bring to market strategic initiatives and simplify complex technical concepts. She focuses on identity assurance, security, and risk management strategies to help organizations balance requirements for technology, people and business processes. At Adobe, she is a core member Adobe’s digital identity and cloud signatures team, providing marketing and engagement strategies to expand Adobe Cloud Signature Provider partnerships and bring secure remote e-signing solutions to customers around the world.

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More information on Adobe Sign Validation here

Best Practices to Validate and Leverage Adobe Sign in a GxP Environment

The life sciences industry is evolving to be more distributed, collaborative, and efficient than ever, leading teams to break free from paper-and-ink (and its bottlenecks) and to leverage e-signature solutions. With specifically designed, intuitive functionality for regulated organizations, Adobe Sign can deliver verified and trusted electronic signatures anywhere, on any device.

However, with strict worldwide regulations around electronic signatures, it's not easy to digitally transform your business if you don't know where to start. To tackle this problem, Montrium and Adobe have teamed up to ease the validation burden on life science teams and speed up the validation process.

This is a follow up to our first webinar in April 2020. In this session, we will be joined by Adobe and we'll present the key steps you should be taking to implement and validate Adobe Sign for use in 21 CFR Part 11 and Annex 11 GxP environments. We will also highlight the customer perspective of Pharmascience, a company that leveraged Montrium's services to validate Adobe Sign in early 2020.

The webinar covers the following topics:

  • Demystifying remote signatures
  • Overview of Adobe Sign and its partner ecosystem
  • Part 11 capabilities and a customer’s point of view on key considerations
  • How to apply a strategic framework to validation
  • Results from Pharmascience's customer experience validating Adobe Sign
  • Adobe Sign's free validation packs
  • Montrium Toolkit offering available to help accelerate your transition

Who will benefit:

  • VP/Director of Quality and Compliance, Information Technology, Quality Systems, Clinical Information Systems
  • VP/Director of Manufacturing Operations/ Quality Operations/ Supply Chain/ R&D
  • Document/ Records Managers/ Directors
  • VP/Director, Regulatory Operations/ Regulatory Affairs
  • IT System Managers and Administrators