Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.
You must follow best practices for developing a validation program that includes planning, execution and maintenance components to ensure that these efforts will meet all regulatory agency requirements and expectations. Preparedness will improve your relationship with the agency and ensure a more cooperative and successful audit experience. Join this session with expert speaker Carolyn Troiano to learn all about preparing your system validation documentation for an FDA audit of your company’s computer systems.
Why You Should Attend:
One of the most critical aspects of validation is the testing phase, which includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ). A protocol must be prepared and followed for each one, along with a summary report. These activities will ensure the system is properly installed, and that not only does the core functionality work, but it works in the way the user will challenge it during day-to-day operations. You will learn about the testing component of computer system validation (CSV) work that’s aligned with the system development life cycle (SDLC) methodology, which includes:
Determining the category of your system, based on GAMP 5 from ISPE
Determining the risks associated with the various ways your system may fail
Using the category and risk, develop a rationale for the level of testing that will be needed to assure your system is thoroughly vetted
Objectives of the Presentation:
The testing component of computer system validation (CSV) work that is aligned with the system development life cycle (SDLC) methodology
The FDA requirements for documentation of all testing activities
How to write a test protocol for each phase of testing, i.e. IQ, OQ, and PQ)
How to develop test scripts and acceptance criteria
How to identify test discrepancies and distinguish the type: test script errors, tester errors, and system errors
How to document all testing and the summary reports
How to maintain the system in a validated state, and keep testing as a ‘living’ exercise that runs through the system life cycle
Areas Covered in the Session :
Definition and examples of GxP systems
Key premises of the FDA regulatory oversight
Definition and key takeaways of CSV
Key elements of SDLC
Risk assessment to plan and execute testing
Software categorization: Specific criteria and rationale
IQ/OQ/PQ and testing
GAMP 5 “V” model
Use of vendors and contractors
Validation plan and test plan requirements
Testing protocol and examples
Handling result deviations
Test documentation requirements
Requirements traceability matrix (RTM)
Preparing a testing summary report
System acceptance and notification
Standard operating procedures and templates
Training
Conducting periodic reviews
Who Should Attend:
Information technology analysts
QC/QA managers
QC/QA analysts
Clinical data managers
Clinical data scientists
Analytical chemists
Compliance managers
Laboratory managers
Automation analysts
Computer system validation specialists
GMP training specialists
Business stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance and audit
Consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance
Auditors engaged in the internal inspection of labeling records and practices
Manufacturing Analysts and Supervisors
Supply Chain Managers and Analysts