Optional paid certificate for the free course Data Integrity & ALCOA+ in Practice. The learning is free; this is the graded assessment and the verifiable certificate.
A 32-question exam drawn at random from a substantially larger bank, balanced across all six modules. Pass mark 78%, three attempts, 80 minutes.
What it is not: Cuabity is not affiliated with PIC/S or the MHRA. This certificate is not an accreditation, not a recognised qualification, and not a substitute for employer training or regulatory sign-off — it records that one named person passed one named assessment on one date, verifiable by anyone.
Optional paid certificate for the free course Computer System Validation in Practice. The learning is free; this is the graded assessment and the verifiable certificate.
A 30-question exam drawn at random from a substantially larger bank covering all ten modules. Pass mark 80%, three attempts, 60 minutes. Questions test judgement — how much assurance a system needs and how to get it — not recall of clause numbers.
Cuabity is not ISPE and is not endorsed by them. This certificate records individual knowledge; it is not regulatory advice, and requirements in this field are changing.
What it is not: Cuabity is not affiliated with ISPE, the EMA, the FDA or PIC/S. This certificate is not an accreditation, not a recognised qualification, and not a substitute for employer training or regulatory sign-off — it records that one named person passed one named assessment on one date, verifiable by anyone.
What data integrity actually requires of you, built from the guidance inspectors use: PIC/S PI 041-1, with the MHRA data integrity guidance on culture and environment. The nine ALCOA+ attributes and how each one fails; criticality versus risk; paper records; computerised systems and audit trail review; and what a company is expected to do when it finds a problem itself.
Free to learn. An optional verifiable certificate is available separately.
Free to learn. Computer system validation for quality professionals, assuming no IT background whatsoever.
Ten modules. The first five build the reasoning — what you are protecting, who requires what, how much assurance is enough, what you have, and the lifecycle. The next four are the cases other CSV training skips: cloud and software you cannot see inside, spreadsheets, IT infrastructure and virtual machines, and artificial intelligence. The last covers keeping a system valid for the fifteen years after the project ends.
Includes a toolkit of six templates you can adapt and use: system inventory, validation plan and report skeletons, spreadsheet control checklist, supplier and SaaS questionnaire, AI tool assessment aid, and a periodic review record.
GMP-first. Annex 11 and PIC/S PI 011-3 lead; Part 11 and FDA's Computer Software Assurance guidance are covered in their own right. GAMP concepts are taught in our own words — Cuabity is not ISPE and reproduces none of their text.