We will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.  We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and the importance of managing electronic records and signatures appropriately.

We will review various approaches to validation, including the traditional Computer System Validation (CSV) approach. We will also discuss Computer Software Assurance (CSA), FDA’s draft guidance for validation. Where CSV is document-driven, CSA is guided by critical thinking, with documentation being the final proof work was done correctly. We will discuss waterfall and agile methodologies for development, testing, configuration, and validation. We will cover automated testing and how it can be incorporated into validation testing. We will also cover technology, including on-premise systems, Computer-Off-the-Shelf (COTS) software, cloud services, and Software-as-a-Service (SaaS) solutions. The best approaches for validating systems in these environments will be discussed.

We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation for operational activities that must be developed and followed to ensure compliance.  We will provide an overview of practices to prepare for an FDA inspection, and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.

Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.

Areas Covered

Course Level- Intermediate

Who Should Attend

Why Should You Attend    

We have used our real-world experience to design a computer system validation course that not only meets FDA, ICH, and Eudralex expectations for risk-based validation, but also prepares you to implement these practices in your company.  The standard operating procedures and validation templates used in class have already been proven at other companies.

We are focused on your comprehension and application of the CSV techniques that will result in efficient, effective, and inspection-ready validation initiatives.

Topic Background    

Computer system validation has been regulated by FDA for more than 40 years, as it relates to systems used in the manufacturing, testing and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries.  The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11.  This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk.  The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process.  System size, complexity, business criticality, GAMP®5 category and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries.  These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA.  All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, and image files, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.