Reporting: What is an audit trail?
What is in the report?
Regulations require strict system security. Carefully selected users must have unique usernames and passwords to work the monitoring system. Every action (automated and manual) must be annotated, describing who did what and when. Every setting, alarm, and login must be collected in an audit trail for the entirety of the operation. The audit trail also includes raw, unadulterated data, temperature excursion reports and their information requirements along with internal comments. It even captures the battery status and connection information.
- Where did the alarm go off? Which facility, container, or sensor had an excursion?
- When did the temperature excursion occur and when were the drug label conditions re-established?
- How long was the product exposed to temperatures outside the drug label conditions?
- What was the highest/lowest temperature measured?
- Which product, batch, or pallet was potentially affected?
- Risks? Is it likely that the core temperature of the product was affected, thus damaging the product?
- Is there sufficient stability budget left to justify a release of the product or is a product recall necessary?
- What was the cause of the temperature excursion? Should there be a corrective action? Do people need to be informed about the findings?
- Which preventive actions can be performed in order to prevent the event from reoccurring? What changes should be implemented?
When is data consolidated?
If the purpose is none other than archiving data, a monthly report is sufficient. A weekly report may be necessary for a roundup of sensors during a project. A closely studied report may be more appropriate for daily analysis.
There are different storage and archiving requirement for these reports. Users access data regularly within the first two years for making business decisions. Afterwards, it should be stored in a secure and easily accessible archive for a minimum of 10 years.
Where are the reports?
The data must be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available over their entire life cycle. The legacy data storage system has been onsite, on a local network and server with software that is downloaded. The owner is responsible for the entire system’s configuration, security, updates, and maintenance.
Growing organizations are upgrading to a cloud system. Software as a Service (SaaS), also known as cloud application services, represents the largest cloud market. SaaS delivers (business) applications that are typically accessed directly via web browser and do not require any downloads or installations on the client side. But, the cloud requires internet access for operation and access to data. The upside is that data that is being collected in one place can be read anywhere there is internet or cell service. The benefits are the cloud providers are responsible for security, maintenance, storage space (to include back up storage), and updates.
Cloud vs. On-Premises
Compare the systems to find what is right for you.