Audit trail simply explained

Audit trails are mainly used for the following reasons:

• Compliance with legal requirements and regulations, especially in the strictly regulated process manufacturing industry
• To support the search for errors
• Usage-dependent determination of maintenance intervals
• Inspection of safety risks and problems

The situations in which audit trails are used depend mainly on the industry of the respective company. Typical situations in which audit trails are used are

• IT security attacks, for example in the event of a hacker attack
• Failure of cooling systems
• Fraudulent business activities
• Loss of data and information
• Significant changes to data (properties, shelf life, etc.)

Audit trails include information about

• who (user)
• at what time (when/time stamp)
• with what (device/system)
• what activity (event and resulting data) was carried out and
• why (justification).

This information can be recorded both automatically and manually. The actual review of the audit trail information takes place in an audit trail review.

The audit trail review defines the information and criteria that are relevant to the event that has taken place and which persons are responsible for carrying it out. The review also specifies the manner in which the audit is to be conducted and the intervals at which audits are required.

Typical formats for audit trails are CSV, XML, YAML and JSON.

Long-term retention of audit trails after an audit trail review can prove difficult for many organizations, as the logs can take up extensive storage space that may not be readily available. However, where possible, retain the audit trail for the life of the records. These can be extremely useful in reporting and resolving issues in the future.

Audit trails are mainly used in regulated industries. These are mostly in the life sciences sector, i.e. industries such as pharmaceuticals, chemicals, biotechnology, cosmetics, food and medical technology. These industries are particularly regulated and therefore require complete documentation of all process steps.

Audit trails enable and document safe processes and help to comply with regulations. As a rule, data such as batch information, e.g. best-before date (BBD) and split, changes to item or batch and serial number data are recorded.

• Pharmaceuticals: For compliance with Good Manufacturing Practices (GMP) and FDA regulations.
• Chemicals: For compliance with REACH and other chemical regulations.
• Biotechnology: For traceability and compliance with biotech-specific regulations.
• Food: For traceability and food safety in accordance with HACCP and FDA.
• Cosmetics: To ensure product safety and compliance with cosmetics regulations.
• Medical devices: For compliance with ISO 13485 and other regulatory requirements.

The reasons for this are:

• Strict regulations: Each of these industries is subject to strict legal and regulatory requirements.
• Product safety and traceability: Critical for the traceability of products and ingredients.
• Quality control: Ensuring that all products meet the required quality standards.

An audit trail helps to document all relevant data changes, process steps and user actions in a transparent and traceable manner, which is essential for compliance and quality assurance in these industries.

The U.S. Food and Drug Administration (FDA) defines the requirements for audit trails. In 21 CFR part 11, it requires that an audit trail is always necessary if a document is generated and signed exclusively electronically. It is also the EU that requires the use of audit trails in Annex 11 of the GMP Directive. Companies that do not meet the requirements and do not enable audit trail reviews receive a warning letter from the FDA. It penalizes the respective company for lack of data integrity.

Software solutions that are suitable for the life sciences industries must meet the requirements for audit trails. This is particularly important in an ERP system. It must be specially designed to enable audit trails reliably and consistently.

Yaveon 365 offers comprehensive functions such as complete documentation, electronic signatures and user authorizations that are specially tailored to the strict regulatory requirements and quality standards of the life science industries. They enable complete traceability of data changes and processes, which is essential for compliance and quality assurance.