Why Should You Attend:

This webinar describes exactly what is required for compliance with Computer Software Assurance guidance, 21 CFR Part 11, and the European equivalent Annex 11 for local, and SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance..

Areas Covered in the Webinar:

Which data and systems are subject to Part 11 and Annex 11
How to write a Data Privacy Statement
What the regulations mean, not just what they say
Avoid 483 and Warning Letters
Requirements for local, SaaS, and cloud hosting
Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
How to use electronic signatures, ensure data integrity, and protect intellectual property
SOPs required for the IT infrastructure
Product features to look for when purchasing COTS software
Reduce validation resources by using easy to understand fill-in-the-blank validation documents

Agenda:

What 21 CFR Part 11 means today
- Purpose of Part 11
What does Part 11 mean?
- SOPs
- System features
- Infrastructure qualification
- Validation
Security standards
- Roles
- Usernames and passwords
- Restrictions and logs
Data transfer standards
- Deleting data
- Encryption
Audit trail standards
- Types of data
- High risk systems
Electronic approval standards
- Electronic signatures
- Single sign-on
- Replacing paper with electronic forms
Infrastructure qualification
- How to efficiently document qualifications
Validation
- Software validation for vendors
- Computer System Validation for users
- Fill-in-the-blank templates
- Change control re-validation
SaaS/Cloud hosting
- Responsibilities for software vendor and hosting provider
- Evaluation criteria
- Hosting requirements
SOPs
- IT, QA, validation
- Software development
Annex 11
- Comparison with Part 11
EU GDPR
- Data Privacy Statement

Frequently Asked Questions:

How do you suggest communicating to the vendor the importance of all versions (even minor) being validated prior to implementation?
All log ins and log outs must be visible in audit log? even log outs due to inactivity?
Does Single Sign On (SSO) capability go against the "passwords are not remembered" rule?
For the new Data Privacy role will that be a QA or IT position?
What exactly is the validation that needs to occur each time my vendor deploys a minor and major release?
How can we get access to infrastructure qualification templates?
You talked about data retention, so is the data supposed to be deleted or archived from a compliance perspective?
Do you have any advice for validating software systems that were in place for many years prior to being required to have validation reports?

Who Will Benefit:

GMP, GCP, GLP, regulatory professionals
QA/QC
IT
Auditors
Managers and directors
Software vendors, hosting providers

Data Integrity & Privacy: 21 CFR Part 11, SaaS/Cloud, EU GDPR Compliance