E-Signatures in Pharma: Challenges, Solutions, and Best Practices
4:00 PM – 5:30 PM, Central European Time (CET)
10:00 AM – 11:30 AM, Eastern Time (ET)
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Overview
The availability of electronic signature solutions to the Pharmaceutical industry has undergone massive expansion in recent years in terms of the number of solution providers and the uptake in the industry (thanks to COVID!).
The facilities preferred by the solution providers can vary significantly in relation to the terms and services available and the budgetary considerations.
This makes it difficult for life science organizations to know which solution is going to be right for them:
- How would the implementation need to be adapted for the technologies are chosen?
- How can organizations show compliance with the necessary regulations applicable to them?
This webinar aims to break down the requirements, cutting through the jargon and sales talk, to look at the common sense practical considerations to mitigate the benefits, risks, and challenges of using eSignatures in the 21st Century.
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Who Should Attend:
- QA Professionals with responsibilities for auditing documents and data using electronic signatures
- Skill Level: Novice, Intermediate
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Topics:
- Regulations
- 21 CFR Part 11
- EU Annex 11
- Electronic / Digital Signature Solutions
- Key Players / Minor Concerns
- Signature Workflows
- Typical Challenges
- Other considerations
- Integration / Replacement of Internal Systems
- Summary
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Special event information:
- Free certificates for live attendees.
Speaker
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Trev SimmonsOwner & Principal Consultant at TS CSV QA LtdTrev is an experienced Data Integrity, Computer System Validation, and Quality Assurance professional with twenty-eight years of experience within the pharmaceutical device industry. Trev has been an active member in the Pharmaceutical industry working on committees and working parties with industry associations and univ developing training courses and guidance for QA professionals for CSV, Data Integrity and Electronic Records and Signatures and Quality Risk Management
Trev has worked with both small and large companies within the industry including Sponsor Organizations, CROs, and niche IT / PV Service Providers on systems with 70k+ users.
Partner
Cygnature by Cygnet Infotech
Website
https://www.cygnature.io/Cygnature is part of a global technology organization, Cygnet Infotech. Cygnet Infotech offers products, platforms, and services across Product Engineering, RPA, Test Automation, Digital Transformation, Tax Technology, and Fintech besides Digital Signature. It has a team of over a thousand people who work on leading technologies, application development on microservices architecture, including Hyper automation, AI & ML, Blockchain, and others, in offices across India, the USA, Europe, the UK, UAE, South Africa, Australia, and other locations.
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