- Speaker : David Nettleton
- Session Code : DNAPR1422
- Date : 14th April 2022
- Time : This webinar is over and the same will occur back in July 2022
- Duration : 90 Mins
Excel Spreadsheets - Ensuring Data Integrity and 21 CFR Part 11 Compliance
Overview:
This
interactive webinar explains how to configure and validate a GxP compliant
spreadsheet applications to avoid FDA 483s.
Follow the step-by-step instructions as we configure Excel for audit
trails, security features, and data entry verification. Understand how to
validate your application with minimal documentation. Bring your laptop and use
Excel for your own needs.
This
session will make you a better Excel user, saving you time and costs.
Areas
covered during the session:
- Develop
spreadsheet applications that are GxP compliant
- Learn
how to use Excel’s built in 21 CFR Part 11 features
- Apply
features required for GxP environments without programming macros.
- Follow
along as we configure Excel for audit trails, security features, data
verification, and multiple concurrent users
- Avoid
483s and Warning Letters
- How
to use cell and file protections
- Reduce
validation time and costs
- Increase
compliance while lowering resource needs
- Validate
your application with minimal documentation
- Understand
what does and does not need to be validated.
- How
to specify and test your application
Learning Objectives:
Why
are spreadsheets so popular?
- Spreadsheet
overview
- What
are they used for?
Why
is compliance a problem?
- How
is it different from a calculator?
Developing
Part 11 applications
- Security
- Versioning
- Cell
protection
- Data
entry checks
- Audit
trail
- Data
output formatting
Validation
- Fill-in-the-blank
validation templates
- Step-by-step
validation
Using
the validated application
- Maintaining,
upgrading, re-validation
Examples
- Requirements
- Specifications
- Test
cases
How
to turn on the audit trail
- How
to view the audit trail
Who
will benefit?
- Excel users in FDA Regulated Environment
- IT
- QA
- QC
- Laboratory
staff
- Managers
- Executives
David Nettleton Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation.
Mr. Nettleton is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 300 mission critical laboratory, clinical, and manufacturing software implementation projects.
Mr. Nettleton recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.