Software development lifecycle workshop
A structured roadmap to building compliant and high‑quality software
How to approach software development and documentation with good SDLC practices for regulated environments
This workshop guides participants through best‑practice software development lifecycle (SDLC) approaches tailored for regulated environments.
We explore how to integrate compliance, documentation, and quality assurance seamlessly into every development phase. With practical examples and case studies we will demonstrate how to maintain traceability, manage risks, and prepare for audits without slowing innovation.
Participants will learn strategies for selecting tools, structuring documentation, and aligning processes with industry regulations such as GxP, ISO, or FDA requirements. By the end of the session, attendees will have a clear, actionable framework for building compliant and high‑quality software solutions.
What you will learn
What standards and guidelines to follow
Where to start and how to approach the whole development process
How to structure traceability and design documentation
How to perform validation of the software
How to manage risks and perform verification and testing
What are the minimal requirements for different regulation
Who should attend?
✔ Software developers and architects working in regulated environments
✔ QA/RA teams responsible for documentation and validation
✔ Product managers and tech leads aiming to align processes with regulatory standards
✔ Companies developing life sciences, MedTech, or diagnostic software that must comply with GxP, EU or FDA regulation
Delivered by
BioSistemika team of senior software engineers, regulatory specialists, and project leads with hands-on experience implementing software development lifecycle best practices in regulated software projects.
BONUS: Participants receive an SDLC compliance framework document with practical templates for documentation, traceability, and validation planning. This resource helps teams implement structured processes that ensure both regulatory compliance and efficient development.
Let’s talk about your team’s training needs
Contact us to plan an internal session for your company.
