With new guidelines and requirements in place the focus of both FDA and international inspections is shifting shift more and more to computer systems and Electronic records. An example is the new EU Annex 11 with requirements for periodic evaluation, vendor agreements, incident management and structured back-up. Just in the last three years more than 30 warning letters mentioned violations for computer systems, some of them with disastrous consequences for the companies. Most companies have a computer validation and Part11 compliance program in place, but either it is wrongly designed, not implemented or not followed.
Reference material for easy implementation:
SOP Auditing Computer Systems
Part 11 checklist
Checklist
Areas Covered in the Session :
FDA regulations and guidelines
10 most frequently found deviations and how to avoid them
Developing an SOP for audits of computer systems.
Effective development and use of audit checklists
Conducting the audit: review procedures, walk through the computer system area
Most critical computer system questions to ask: traditional and new ones
Auditing for data integrity
Documenting detailed audit findings
The audit summary report
Auditing in preparation for FDA’s new Part 11 initiative
Case study: going through a life audit
Who Should Attend:
IT Departments
QA Departments
Operations Departments
Users of computer systems in regulated areas
Analysts and lab managers
Validation specialists
Training Departments
Documentation Departments
Consultants