Course Description
“Introduction to Automation Documentation“ explores various types of documentation crucial for successful automation projects, focusing on their applications in regulated industries. The second module, “How to Read and Write Project Lifecycle Documentation“, delves into the purpose and key components of essential documents like the User Requirements Specification (URS), Functional Requirements Specification (FRS), Software Design Specification (SDS), and Software Testing Protocol (STP), guiding you on how to write and review them. The third module, “Operating Instructions, Procedures, and Records“, provides a comprehensive understanding of documents essential for the operation, maintenance, and validation of automation systems, particularly within the life sciences industry. It explores the development, management, and utilization of operating documents, standard operating procedures (SOPs), records, and plans. The fourth module, “Change Control and Redlining“, offers insights into the change control process and the practice of redlining, highlighting best practices for change tracking, error flagging, and implementing and testing code updates.
Who Will Benefit
Automation engineers, project managers, technical writers, quality assurance professionals, and regulatory compliance officers working in regulated industries such as pharmaceuticals, biotechnology, and manufacturing. It is particularly beneficial for those responsible for developing, managing, and maintaining automation project documentation.
