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Administration and security

Validation kit (UAT / PQ)

How a company tests YouEDC internally: scripts, demo study, sign-off, report.

The validation kit helps a company test YouEDC internally before relying on it: ready test scripts, a demo study to run them on, a record of every step, a sign-off and a report for the validation file. It is the customer's user acceptance testing (UAT) and performance qualification (PQ) in GAMP 5 terms.

Validation kit: the tester's path Available only to people the Portal Owner allowed, personally or through a group. 1 Start demo study: 3 sites, test data; demo DM project in YouEDC Studio 2 Scripts 8 scripts, 32 steps: sign-in, roles, audit, lock, sites, YouEDC Studio, languages, Portal Owner 3 Record each step: pass, fail or n/a; what you saw: required for failures 4 Sign e-mail + password, meaning of signature; printable report and Excel, audit trail ! This is the customer's own test (PQ / UAT), not validation done for them. The report shows fitness for your intended use; the decision and the SOPs stay with your company.
The tester's path: starting a run creates the demo projects, then each step is recorded, and finally the run is signed and the report downloaded.

Who sees the kit

Only people the Portal Owner allowed personally or through a group (for example “UAT testers”). Others do not see it in the menu, and its addresses answer “No access to this function”. How to allow someone: see “Access management”.

How to run it

  1. Open “Validation kit” in the left menu and press “Start the run”. Give it a name (for example “UAT of registry X, cycle 1”) and say where you test: browser, computer, network.
  2. The portal creates a demo study UAT-… with three sites and a demo DM project in YouEDC Studio. The data is made up; there are no real patients.
  3. Execute the scripts in order. For each step record pass, fail or n/a and write what you saw. A comment is required for fail and n/a.
  4. When every step is recorded, sign the run: e-mail, password and the statement “I executed these tests myself and the recorded results are true and complete”. After signing the results cannot change.
  5. Download the printable report (or save it as PDF from the browser) and the Excel file. The report carries the portal version you tested, every step and the audit trail of the run.
Example. At step UAT-04.4 an invitation went through after the lock. Record “fail”, describe what you saw, raise a deviation in your quality system and tell us. After the fix, run again on the new version.

What the scripts cover

  • UAT-01 sign-in and passwords, UAT-02 roles, UAT-03 audit trail, UAT-04 database lock, UAT-05 sites;
  • UAT-06 a DM project and a YouEDC Studio tool, UAT-07 languages and time, UAT-08 Portal Owner access control (needs a Portal Owner).

Each step names the requirements (URS) and the clauses of 21 CFR Part 11, EU Annex 11 and ICH E6(R3) it supports. The vendor's full package (validation plan, URS, FS, risk assessment, traceability matrix, IQ/OQ) is in the docs/validation folder of the repository.

What the kit does not do

It does not validate the system for you. The decision on fitness for use, SOPs, training and change control stay with your company. The sign-off in the kit records the run with your name, the time and the meaning; it does not replace your own electronic signature procedure.