If you use YARDtwin in a GxP process, your change control needs to know when a release could affect the system you validated. Every entry on the public changelog that may do so carries a GxP flag, and YARDtwin can also e-mail the notice to up to five people in your organisation.
What the GxP flag means
Each flagged change states its impact under 21 CFR Part 11 (electronic records and signatures) and EU GMP Annex 11 (computerised systems):
- Indirect: review the change. Regression testing is generally enough.
- Direct: assess the change against your validated state. Targeted re-qualification is likely.
- Re-validation advised: we recommend you re-validate before relying on the change in a GxP process.
Each flag is set by a person who has reviewed the change. On the changelog, click GxP impact only to list just the flagged changes.
Switch the notices on
- Go to Site Admin → Profile and find GxP release notices.
- Tick Send GxP release notices to my organisation.
- Enter up to five e-mail addresses, for example your QA and validation leads. Click + Add a recipient for another box.
- Click Save.
The setting applies to your whole organisation, not just the site selected at the top of the menu. Each change to it is recorded in the audit trail with who made it. Only administrators see this setting.
What a notice contains
Each notice names the version, every change it covers with its Part 11 and Annex 11 impact, and whether re-validation is advised. It also says whether each change has already reached production or is planned for a date. Where we can, the notice arrives before the release. It links to the changelog and says how to unsubscribe.
You are told about each change once. Your organisation's audit trail records each notice sent to you.
Stop the notices
Untick Send GxP release notices to my organisation and click Save. The addresses are kept, so you can switch the notices back on later without typing them again.