Description
The objectives of this professional certification are to give learners a strong understanding for the principles of Computer Software Assurance (CSA), overview of Computer Systems Validation (CSV) and the documentation associated with a complete Software Validation Lifecycle (SVLC).
There are 11 individual courses included with the Computer Software Assurance (CSA) Professional Certification program. These courses are described below.
GxP: Good Practices (GxP) in Drug Development and Manufacturing: This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
Introduction to Validation: This program introduces validation and to the regulations and guidance that apply to it. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company.
Introduction to Software Validation (Part 1 of 2) (Planning): This course focuses on software validation for support systems. These are the systems used to develop, deliver, measure, maintain, or assess products such as, Document Management Systems (DMS), Manufacturing Execution Systems (MES), and control systems. The main purpose of this course is to help students establish a solid validation process.
Introduction to Software Validation (Part 2 of 2) (Implementation): This course provides an overview of the FDA and European requirements with practical exercises covering the implementation of those requirements. The course covers the application of these requirements to the validation of both computer hardware and software systems used in manufacturing, QA, regulatory and the control of processes.
Validation & Compliance: Commercial-off-the-shelf (COTS), Software-as-a-service (SaaS) and Cloud Systems: Validating Commercial Off-The-Shelf (COTS) software, Software-as-a-Service (SaaS), and cloud systems involves ensuring that these solutions meet the specific functional, security, and regulatory requirements of the organization using them. This process includes thorough risk assessments, security evaluations, and compliance checks to verify that the software operates as intended within the organization’s environment and complies with industry standards such as ISO/IEC 27001 for information security management and GDPR for data protection.
Computer Software Assurance: The FDA’s approach to Computer System Assurance (CSA) represents a modernized perspective on computer system validation (CSV), aiming to ensure that systems used in the pharmaceutical, medical device, food, cosmetic, and dietary supplement regulated industries are reliable, consistent, and meet quality standards without imposing unnecessary burdens on the industry.
Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures): Part 11 of Title 21 of the US Code of Federal Regulations (21CFR11) sets out requirements that computer systems must meet to satisfy the Food and Drug Administration (FDA), and to assure that electronic records and electronic signatures provided by those systems are trustworthy and reliable to the same extent as paper counterparts.
Validation Plans and Documentation: This program describes the purpose, content and use of validation master plans, project validation plans, and other documentation for validation projects in the medicines and healthcare products industries. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company.
Commissioning and Installation Qualification (IQ): Before equipment can be used routinely in production, it must first be commissioned and, if necessary, undergo Installation Qualification (IQ). This module describes commissioning and IQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.
Operational and Performance Qualification (OQ/PQ): This program describes OQ and PQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.
Data Integrity: This course describes data integrity as part of FDA, EU and PIC/S GMPs. It defines risk management methods and controls, as well as several different scenarios that have led to errors relating to computer systems.
