Course Description
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” products, 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.
Major areas covered by Carolyn Troiano in this online CPE course on Information Technology:
- How to identify “GxP” Systems
- The Computer System Validation (CSV) approach is based on FDA requirements
- The System Development Life Cycle (SDLC) approach to validation
- The best practices for documenting computer system validation efforts, including requirements, design, development, testing, and operational maintenance procedures
- How to maintain a system in a validated state through the system’s entire life cycle
- How to assure the integrity of data that supports GxP work
- The importance of “GxP” documentation that complies with FDA requirements
- The policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
- The key components of 21 CFR Part 11 compliance for electronic records and signatures
- The regulatory influences that lead to FDA’s current thinking at any given time
- How to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale
- What is 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 rationale?
- How to assess risk, based on probability of occurrence, the severity of impact, detectability, and mitigation, along with technical and procedural controls that can help minimize risk
- How to best prepare for an FDA inspection or audit of a GxP computer system
- The importance of performing a thorough vendor audit to ensure oversight of the products and services they deliver
- 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 cycle
Click here to access online CPE webinars on Information technology.
