• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Risk Management Professionals
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• Contract Research Organizations (CROs)
• Laboratory Testing Facilities for Clinical Samples
• Vendors and consultants working in the life sciences industry who are involved in computer system development, implementation, testing, validation, maintenance and compliance

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.

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.