Product/Service

Pharmaceutical Environmental Monitoring Systems Data Security: RMS Data Security Data Integrity

RMS Data Security/Data Integrity/FDA Conformity

Data security, data integrity, data availability: these three terms play a central role in monitoring systems. The RMS reassuringly scores in all these fields.

Data Security

Data security means the data cannot be accessed by unauthorized persons. This is achieved through encryption during data transfer and storage.

Data Security in RMS

The monitoring system provides encryption of the data during transfer. This means the data can neither be tapped or manipulated by so-called retry attacks. The security of the stored database in RMS is ensured by the IT structure. The Rotronic Cloud is protected by certified IT data centers. If the database is located in the customer's server center, the customer defines the security infrastructure. Rotronic then offers IT support.

FDA/GMP Requirements

Regulators in the pharmaceutical and food industries demand that all relevant events are recorded so they are traceable. This is achieved through the electronic marking of all calibration measurements and verification processes. The so-called "electronic recording" requires unique identification of certificates. This means that every calibration certificate with a date and inspection stamp must be traceable such that the calibration chain can be verified.

Audit Trail

When a monitoring system is commissioned, it is calibrated and validated. In this way the operator assures his Quality department that the system works correctly. During subsequent operation, all relevant changes must be recorded in full. The audit trail guarantees recording of all changes in the system such as, for example, change in measurement probes, user activities, battery change. This in turn ensures that all events can be tracked at a later date.

Data Availability

For some manufacturar's systems, data availability can contradict data security because secure data are difficult to access. The user must authenticate themselves and use secure connections or verified platforms. Nevertheless, the trend is clearly moving towards worldwide data accessibility allowing platform-independent viewing and evaluation.

Availability of Data Centers

Thanks to the server database and Server Software, very high availability of the data is already implemented in the basic concept of the Rotronic RMS. The data can be viewed without problem from anywhere in the world with all conventional devices. Security is guaranteed by user rights and authentication.

Data Integrity

Ensuring data integrity means guaranteeing secure transmission and storage. A measured value must not change during transmission because of disruptions. Data transmission and storage must therefore be safe from manipulation. This is achieved with CRC checksums and intermediate storage during data transmission. In this way, faulty data communication is recognized and the data stored in the buffer memory are sent again until the transmission has been finished. 

Data Integrity in RMS

All data in RMS are sent with CRC checksums and confirmed by the recipient after receipt. Faulty data transmission is thus ruled out. Should the data not arrive with the recipient, they are stored intermediately by the logger and can then be transmitted at a later point in time when the connection has been restored.