Digital Quality & ComplianceComing soon
Course facts.
LevelFoundation, no validation experience needed
FormatLive first, then self-paced chapters
Completion windowOne month from enrolment
AssessmentGraded, with certificate on passing
Who this course is for.
I work in industry
Refresh your CSV, adopt CSA properly and defend both in an audit.
I study at university
Learn the single most hireable skill in pharma IT quality from scratch.
Course outline▼
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Click a module to see every lesson.
01
What is CSV/CSA?
Why validation exists and how the industry's approach has shifted.
- 1.1 How computer validation became standard in pharma
- 1.2 Why CSV exists: patient safety and data integrity
- 1.3 CSV vs CSA: what is changed?
- 1.4 Inside FDA's 2025 CSA guidance
02
The regulatory landscape
Navigate the frameworks that govern validated systems.
- 2.1 21 CFR Part 11: electronic records and signatures
- 2.2 GAMP 5: risk-based validation and software categories
- 2.3 GxP fundamentals: GMP, GCP and GLP
- 2.4 EMA Annex 11: the European perspective
03
Risk-based thinking
Decide what gets validated, and to what depth.
- 3.1 What risk-based really means in GxP
- 3.2 GAMP 5 software categories and risk classification
- 3.3 Deciding the depth of validation
- 3.4 Risk assessment tools you will use in practice
04
The validation lifecycle
Follow a system from planning to sign-off.
- 4.1 The validation lifecycle: from planning to release
- 4.2 Validation documentation across the lifecycle
- 4.3 Sign-off and system release
- 4.4 Maintaining the validated state: the role of SOPs
This course is in production and the outline is confirmed. Join the waitlist and we will tell you the moment enrolment opens. Waitlist demand also decides which course we launch next.
What you leave with
A certificate of completion and a validation portfolio practical you can show an interviewer.
Enrolment, waitlists, payment and delivery run on our learning platform at learn.ada.archimedis.io.