In Depth Testing of Computer Systems Regulated by FDA

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

Course Director: CAROLYN TROIANO

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.