Auditing Systems for 21CFR Part 11 Compliance
Overview:
Life sciences companies should regularly audit and assess computer systems for 21CFR Part 11 compliance, both their internal systems used in support of regulated GxP activities as well as systems used by their contract vendors for manufacturing, laboratory testing, drug safety and clinical studies. This is done routinely as self-assessment and inventory of existing systems, during the implementation of new systems, as during vendor qualification and periodic audits.
A methodology for system assessment, risk-analysis, 21CFR Part 11 compliance, remediation and inventory is presented, along with templates and forms attendees may modify for their own business. Case studies are presented showing the outcomes for three regulatory inspections at companies conducted after following this methodology.
"Show me how you manage your computer systems in compliance with 21CFR Part 11." These words from an FDA or other regulatory inspector can send shivers down the spines of your Lab Managers, Information System Manager, End Users and Quality Assurance Managers. This presentation will describe a process which has prepared several pharmaceutical companies to answer this question accurately, completely and to the great satisfaction of the inspectors. We will show how to inventory the site, assess the compliance risk of existing systems, implement new systems, remediate any non-compliance found, prepare SOPs and quality policies, collate the required documentation and train the staff. We will learn how to prepare and present a concise and comprehensive presentation to regulatory inspectors. Preparation and knowing in advance the expectations and required deliverables for a successful inspection is critical to your pharmaceutical, medical device, biotechnology or software company. Case studies are presented showing the outcomes for three inspections at companies following this methodology.
Areas Covered in the Session:
- 21CFR Part 11 Requirements
- Regulatory Inspections of Computer Systems
- Required Policies and Procedures
- Training
- Performing a Comprehensive Inventory: Team Effort
- System Inventory Assessment - Preliminary Risk Assessment
- Compliance Assessment - Compliance Risk Analysis, Gap Analysis and Corrective Actions
- Remediation Plans and Schedules
- Presenting to the Inspector
- Case Studies: Federal and State Regulatory Inspections
Who Will Benefit: This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and data systems will also benefit.
The employees who will benefit include:
- End-users responsible for applications and system
- QA Managers and Personnel
- Information Technology Managers and Personnel
- Senior Quality, Regulatory and Operations Management
- Regulatory Affairs staff
- Quality System Auditors