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Stefan Münch, Rockwell Automation
Yves Samson, Kereon
Wolfgang Schumacher, F. Hoffmann-La Roche
Learn about the requirements of the pharmaceutical industry on computerised systems validation (csv).
Evaluate the expectations of the pharmaceutical industry on supplier’s validation activities.
Learn as a supplier how to establish and defend a quality management system complying with the GMP requirements
Get a picture of the frequent observations and problems from a supplier as well as a customer point of view and how to overcome them.
Learn about the GMP aspects to consider with regard to alternative software development methods.
Regulatory requirements (on the validation) of computerized systems directly address the pharmaceutical industry only. Software engineers are rarely aware of them. While the pharmaceutical industry is regularly audited by GMP inspectors, suppliers of this industry aren’t subject to any official GMP supervision.
However, the pharmaceutical industry has to assess the suppliers with regard to their quality. Appropriate evaluation (audit) reports are expected and also reviewed by the GMP inspectors. Indirectly and consequently, the software engineer has to know the regulations of its customers and understand them. The development of the software must be accordingly qualitative and documented. The course will decidedly address the aspects to consider.
This course is directed at software engineers working for system suppliers and also directed at internal IT employees in companies of the pharmaceutical and medical
industry. The customer’s and supplier’s personnel in the quality assurance departments is also addressed. First experiences in CSV are recommended.
Software Development: From Good Software
Engineering Practice to GxP Compliance
Software development for GxP relevant applications
Good (Software) Engineering Practice
Roles and responsibilities
Leveraging GAMP software categories
Requirements for the Quality System of the Supplier
Annex 11 – Is there a direct impact for the supplier?
Are Health Regulatory Bodies allowed to inspect Software companies?
Essential parts of the Quality System – Hot Buttons
Design of Service Level Agreements (SLA) and
Customer complaints – Bugs
Expectation for the management of subcontractors
Support of inspectors
Programming Standards / Code Reviews
Typical checkpoints in a code review
When to do it and how to follow up
Code review vs. design review
General vs. home-made programming standards
Development Tools / OSS
Risk assessment of development tools
What you should consider when using open source software (OSS)
Risk Management / Change Control / Traceability
Implemented by the Supplier
Why do we need to do this at all?
Risk management as an interdisciplinary process
Impact analysis vs. risk assessment
Which changes to take into account
Traceability put into practice
Testing – the most important quality assurance element?
ISPE’s Good Practice Guide “A Risk-Based Approach to Testing of GxP Systems, 2nd Edition”
Test Automation in regulated industries: Tools, compliance, and ROI
Audit Findings from the Pharma Business Perspective
Evaluation criteria of the pharmaceutical industry
May audits be rejected?
Dos and Don’ts – Recommendations
Problem areas and trends
Discussion of audit observations and corrective actions
Audits – A Supplier’s View / Real-life Experiences
Preparation of a supplier audit
Understanding and achieving audit objectives
How to handle an auditor
Improvements – Corrective and preventive actions (CAPA)
Iterative Software Development & V-model
What „iterative“ really means
Requirements to an iteration
Why iteration planning is crucial
How to improve documentation efficiency
Making Scrum work for the Life Sciences industry
Resolving (potential) conflicts
How to use an agile approach while still being compliant
Regulatory management for software developers /
Understanding the regulatory requirements
21 CFR Part 11
EU GMP Guide Annex 11 functional requirements