We will explore the best practices and strategic approach for evaluating computer systems used in the conduct of 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of managing electronic records and signatures appropriately and data integrity requirements.We’ll cover the latest draft guidance from the FDA on Computer Software Assurance (CSA), a risk-based approach using critical thinking as a driving factor for validation. We’ll talk about the newest GAMP®5, 2nd Edition and how it aligns with CSA. We’ll also cover the thoughts from GAMP®5 and CSA for moving toward non-linear forms of software development, including agile, artificial intelligence (AI), machine learning (ML), and others.We will cover the approach for validating/qualifying all components of FDA-regulated systems, including cloud-based servers and Software-as-a-Service (SaaS) solutions. A different approach is required for auditing and performing Installation Qualification (IQ) for systems supported by these vendors, and we’ll provide the roadmap.We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation and 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, 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 CoveredLearn how to identify “GxP” SystemsDiscuss the Computer System Validation (CSV) approach based on FDA requirementsLearn about Computer Software Assurance (CSA) and how this approach may streamline your validation workLearn the differences introduced by ISPE in the current GAMP®5, 2nd Edition, issued in July 2022.Learn about cloud service and SaaS providers and the best approach for conducting a vendor audit and performing Installation Qualification (IQ) for validationLearn about the System Development Life Cycle (SDLC) approach to software development, testing, and release, including the application of automated testing to streamline activities, particularly for updates.Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance proceduresUnderstand how to maintain a system in a validated state through the system’s entire life cycleLearn how to assure the integrity of data that supports GxP workDiscuss the importance of “GxP” documentation that complies with FDA requirementsLearn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated stateUnderstand the key components of 21 CFR Part 11 compliance for electronic records and signatures and data integrity requirements, both of which are somewhat intertwined.Know the regulatory influences that lead to FDA’s current thinking at any given timeLearn how to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationaleUnderstand the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP 5 category and risk, should it fail, to develop a cohesive and comprehensive validation rationaleLearn how to best prepare for an FDA inspection or audit of a GxP computer systemUnderstand the importance of performing a thorough vendor audit to ensure oversight to the products and services they deliverFinally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycleQ&AWho Should AttendInformation Technology AnalystsInformation Technology Developers and TestersQC/QA Managers and AnalystsAnalytical ChemistsCompliance and Audit ManagersLaboratory ManagersAutomation AnalystsManufacturing Specialists and ManagersSupply Chain Specialists and ManagersRegulatory Affairs SpecialistsRegulatory Submissions SpecialistsRisk Management ProfessionalsClinical Data AnalystsClinical Data ManagersClinical Trial SponsorsComputer System Validation SpecialistsGMP Training SpecialistsBusiness Stakeholders/Subject Matter ExpertsBusiness System/Application TestersContract Research Organizations (CROs)Laboratory Testing Facilities for Clinical SamplesVendors and consultants working in the life sciences industry who are involved in computer system development, implementation, testing, validation, maintenance and complianceWhy Should You Attend A critical element of any computer system implementation project is the infrastructure that supports it. This varies, including hardware and software, and must be a foundation that’s qualified and able to support a system in a validated state.In this webinar, we’ll discuss on-premise servers and software, cloud-based services, and Software-as-a-Service (SaaS) solutions. There are specific things to watch out for to ensure you are properly supported and covered, including security, access control, incident reporting, change control, and maintenance of the system. Learning the best approach for different types of hardware and software will help you simplify your work. Rather than always doing things the way they’ve been done for decades, we’ll provide some thoughts and suggestions about how to leverage technology and the vendor’s work to make sure you’re doing things efficiently and effectively without risking quality or compliance.Topic Background Computer system validation has been regulated by FDA for more than 30 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, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.