Agile Validation in GMP Projects
Brief Introduction to the challenge Agile Vs GxP/GAMP
Possible Agile Approach in Validation Project "Agilized Waterfall"
Lessons Learned out of concrete projects
Possible Agile Approach
Areas covered in this session
-Brief Introduction to the challenge Agile Vs GxP/GAMP
- Possible Agile Approach in Validation Project "Agilized Waterfall"
- Lessons Learned out of concrete projects
- Discussion on pros/cons
Who should benefit
Any person interested in good practice for IT projects, especially in a GxP environment.
Why should you attend
IT landscape in companies changes extremely fast and it is necessary to be able to react quickly to these changes.
Agile approaches are nowadays very commonly used in many areas where SW development is used to be able to overcome these frequent changes and to ensure that business needs are clearly understood.
Still, in a GxP regulated environment, Agile approaches tend to not be applied because of wrong assumptions/understanding: Agile is NOT about Chaos, Freestyle, Absence of Documentation, as one can often hear.
In reality, successfully applying agile methodology always requires even more precise process definition for team collaboration as one would do in a classical V-model approach.
In this session, you will learn how the advantages of agile methodologies can be applied within GxP validation projects.
Wega Informatik AG, with 25 years of experience, we are the preferred partner of IT and business departments to support their R&D and QC projects. Our experts offer in-depth expertise in various areas to help your professionals to understand their business and technical needs and provide perfect support to find and establish a state of the art environment.
Through the tight collaboration between our 4 internal groups, Clinical Development IT, Lab & Research IT, CSV & QA and IT Solutions, Wega provides the full lifecycle support to your company.
Focused on the R&D / QC & CSV aspects, some of Wega's principal topics are:
Strategic Consulting & Business Analysis
LIMS, ELN, LES and paperless Lab
Compound Management& BioBanking
Research Data & Knowledge Management
Project management and project lead
Smart Lab / Lab of the Future
Industry 4.0 Concepts
Active Contribution to SiLA and AnIML
Project Quality Management (CSV)
GxP Validation Strategies & Documentation
Functional Risk Assessment
Vendor and in-house audits