The audit trail is a central element of quality assurance in the MEDEORA GmbH software. It enables the complete and tamper-proof tracking of all relevant database actions and thus ensures that changes to data are transparent and traceable at all times.

Direct database connection

The audit trail is technically linked directly to the database.
This means:

• Every change or deletion of data is recorded automatically.

• Logging takes place in real time and is unalterable.

• It is not possible to subsequently manipulate or delete entries in the audit trail.

Quality assurance tool

The audit trail is a central tool for quality assurance:

• It documents all relevant activities in the system.

• It is always possible to trace who changed what and when.

• This creates accountability and transparency and serves as a basis for internal or external audits.

Secure electronic recording

The audit function is based on a computer-generated, secure electronic record.
This fulfills the requirements for:

• Tamper-proof

• Long-term traceability

• Revisability of the changes

• Legally compliant documentation

Exemplary logged information:

• User name

• Date & time of the action

• Type of action (create, change, delete)

• New value

Traceability of events

The audit trail is particularly relevant for regulated industries such as pharmaceutical research or clinical studies:

• It offers a complete history of all entries.

• Every change to a data record can be traced back to the original creator.

• This supports compliance with legal and regulatory requirements, such as GxP, FDA 21 CFR Part 11 or EU Annex 11.

Advantages of the audit trail

• ✔️ Complete logging of all user activities

• ✔️ Transparency across the entire data history

• ✔️ Increased data security and integrity

• ✔️ Basis for audits & testing processes

• ✔️ Compliance with regulatory requirements

MEDEORA’s audit trail ensures maximum data integrity and makes sure that all activities are documented in a traceable manner – a crucial building block for trustworthy and audit-proof processes.