QP Release Register

The QP Release Register documents all lot releases by a Qualified Person (QP) in a gap-free and immutable manner. It serves as a central, tenant-wide record of lot releases, e.g. for EU-GMP Annex 16.

QP Release Register

Automatic Creation of QP Release Register Entries

An entry in the QP Release Register is automatically created as soon as a lot or serial number changes to a status marked as QP Release Register relevant in the Item Tracking Info Status table. This can be triggered by two processes:

This also includes Lot No. Information Modifications that the system posts automatically, e.g. through Automatic Item Tracking Status Modifications of the app Yaveon 365 Quality Assurance. In this case, the user who triggered the status change is entered as Posting User.

Manual creation of entries is not possible.

Important

Entries in the QP Release Register cannot be changed, renamed, or deleted after creation. This makes the register audit-proof.

Setup

The following setup is relevant for using the QP Release Register:

  1. Activation: In the Yaveon 365 Compliance Setup, the field QP Release Register active must be set. In addition, a QP Release Register Nos. number series must be entered for the gap-free assignment of entry numbers.
  2. Mark relevant statuses (Yaveon 365 Lot Management): In the Item Tracking Info Status, every status whose attainment represents a QP release must be marked with the field QP Release Register relevant. This field is independent of the field Release Status — for a QP-relevant release status, both fields are usually set together.
  3. QP authorization: Who is allowed to manually post a lot to a QP-relevant status continues to be controlled exclusively via the existing Lot No. Information Modification Rules (condition Posted by user ID/Posted by User Group for a change of the field Status). The QP Release Register itself does not check any authorization, it only documents the posting user.
  4. Electronic signature (optional): If an active rule for the triggering action is set up in the Rules for electronic signature, the signature number and the signing user are also shown in the QP Release Register — which action is relevant depends on the trigger path: Lot No. Information Modification - Post Document for an entry from a Lot No. Information Modification, Lot No. Modification - Post Document for an entry from a Lot No. Modification (lot split). Without a matching rule, these fields remain empty.
  5. Reason Code (optional): If a reason code has been entered for the triggering posting via the Reason Code for Item Tracking Modifications, the reason code and its description are also shown in the QP Release Register.
  6. Inspection Order No. (Yaveon 365 Quality Assurance) (optional): If the app Yaveon 365 Quality Assurance is installed, the QP Release Register automatically shows the last Inspection Order for the item, variant, and lot. No separate setup in the QA app is required for this.
Note

Activating the QP Release Register does not perform a retroactive initialization of data. Only releases from the point of activation onward are recorded.

Columns of the QP Release Register

Field Description
Entry No. Consecutive, gap-free numbering from the number series entered in the Compliance Setup.
Item No. Item of the released lot.
Item Description Description of the item.
Lot No. Lot number of the status change. If a lot split was posted as part of the change, the new lot number is shown.
Status The new, QP-relevant status the lot has changed to.
Quantity The released quantity.
Posting User The user who posted the status change.
Posting Date / Posting Time Date and time of the triggering posting.
Posted Lot No. Info Modification / Posted Lot No. Mod The posted document that triggered the status change.
Electronic Signature No. / Signer Electronic Signature Reference to the electronic signature for the triggering posting, if a corresponding rule is set up.
Reason Code / Reason Description Reason code of the triggering posting, if entered.
Inspection Order No. Last inspection order for the item, variant, and lot, if the app Yaveon 365 Quality Assurance is installed.

The action bar allows you to open the linked documents directly.

With the Print action in the QP Release Register, you can output the entries of the register as a report, e.g. to archive the lot releases of a specific period as a PDF file or to present them during an audit. The report is created in landscape format.

  1. Open the QP Release Register.
  2. Choose the Print action.
  3. On the request page, set the required filters:
    • Posting Date: period of the releases to be output, e.g. 01/01/2026..03/31/2026.
    • Item No. and Lot No. (optional): restriction to specific items or lots.
    • Status Filter on the Options FastTab (optional): restriction to one or more statuses. Via the lookup, you can select a status from the Item Tracking Info Status.
  4. Print the report, show it in the preview, or save it as a PDF file.

Filters that you have already set in the QP Release Register list are transferred to the request page.

The report header contains the filters set, the print date, and the printing user. The entries are sorted by Entry No. and output with the following columns:

Column Description
Entry No. Number of the entry in the QP Release Register.
Item No. / Item Description Item of the released lot.
Lot No. Lot number of the status change.
Status The QP-relevant status the lot has changed to.
Quantity The released quantity.
Posting User The user who posted the status change.
Posting Date / Posting Time Date and time of the triggering posting.
Note

The lookup in the Status Filter shows all statuses of the Item Tracking Info Status. Entries in the QP Release Register only exist for statuses marked as QP Release Register relevant.

Note

Document references, electronic signature, reason code, and inspection order no. are not printed. You can still find this information in the QP Release Register list.

Additional Usage Notes

  • Using the QP Release Register is only meaningful if the app Yaveon 365 Lot Management is also used: both the marking of a status as QP Release Register relevant (in the Item Tracking Info Status) and the entire trigger mechanism — the automatic creation of an entry when posting a Lot No. Information Modification or a Lot No. Modification — are implemented exclusively in the Yaveon 365 Lot Management app. Without this app, the register can still be activated in the Yaveon 365 Compliance Setup, but no entries are ever created, since neither the status mechanism nor the triggering documents exist.
  • Entries are only added to the QP Release Register when a lot is changed to a QP-relevant status. It must be ensured organizationally that the QP-relevant status is not used as an initial status, since no entry is created in the QP Release Register in that case.
  • Since the QP Release Register should only contain saleable lots, it must be ensured organizationally that purchased lots or intermediate goods do not receive a QP release status. The system records all items that receive the QP-relevant status, without distinguishing between item groups or similar criteria.
  • Via the conditions Posted by user ID and Posted by User Group in the Lot No. Information Modification Rules, you define who is allowed to change a lot to a particular status — for status changes to a status marked as QP-relevant, this effectively defines who counts as a Qualified Person (QP). The QP Release Register does not check this authorization itself, it only documents the posting user.
  • Changes to serial numbers are currently not recorded.
Important

Automatic status changes are performed as a system posting. Neither the Lot No. Info Modification Rules nor the Rules for electronic signature are checked; the electronic signature fields remain empty in the QP Release Register. It must be ensured organizationally that a status marked as QP Release Register relevant is not entered as Item Tracking Status in the Automatic Item Tracking Status Modifications.