Software - Testo Saveris
Security
The testo Saveris software enables comprehensive analysis and evaluation of all recorded measurement parameters - with access from anywhere. Detailed logging functions and secure archiving of measurement data makes testo Saveris 1 an audit-proof central data management platform that also meets the requirements of the FDA regarding 21 CFR Part 11 and Annex 11 of the EU GMP Directive.
21 cfr Part 11 compliant
The Fraunhofer Institute for Experimental Software Engineering confirms that the testo Saveris 1 measurement data monitoring system meets the requirements of 21 CFR Part 11. Testing took place in accordance with the evaluation guidelines of the GAMP Special Interest Group: complying with 21 CFR Part 11 Electronic Records, Electronic Signatures.
Access-protected PDF reports
For the reliable storage of electronic records, testo Saveris 1 offers the option of restricting the creation of PDF reports to a configurable, predefined report folder. If the user attempts to save the electronic PDF record to another location or to overwrite an existing measurement report, the report creation process is aborted.
Audit trail
Each audit trail records the sequence of processes and activities carried out after the software has ensured a correct sequence by specifying the necessary steps. In this way, testo Saveris 1 ensures that it is possible to perform a system check of events based on the sequence.
User management
The testo Saveris software supports the system administrator in creating and managing passwords through integrated controls such as password length and queries about expiration dates as part of the Windows password policy.
Alarm management
Minimize risks and react quickly to critical situations at all times thanks to a reliable alarm procedure. Alarm management including escalation management available in the software.
Data access 24/7
Full transparency over all your sites / site areas in just one system. Platform-independent access at all times and from anywhere (smartphone, tablet, PC, etc.)
Validation concept
Our experts support you in the validation of your computer and software systems. Together with you, we create a validation concept. The validation of your systems is carried out according to a risk-based validation approach in accordance with the requirements of GAMP 5.
Key Principles of 21 CFR Part 11
- Electronic Records: Part 11 defines when electronic records are considered equivalent to paper records. It necessitates controls to ensure the authenticity, integrity, and confidentiality of electronic records.
- Electronic Signatures: The regulation outlines requirements for electronic signatures to be as legally binding as traditional signatures, including the need for unique user and password combinations.
- Audit Trails: Systems must maintain an audit trail which records all actions taken on electronic records, including who made changes, what changes were made, and when those changes occurred.
Temperature Monitoring Systems
In the context of temperature monitoring systems—such as those used in pharmaceutical storage, clinical trial equipment, or vaccine storage—21 CFR Part 11 compliance is critical for several reasons:
- Data Integrity: Temperature monitoring systems must ensure that the data recorded (temperature readings, alerts, etc.) is accurate and cannot be tampered with. This is vital for maintaining product quality and safety.
- Audit Trails: All readings and actions taken within the monitoring system (such as setting thresholds, acknowledging alarms, or modifying settings) should generate an audit trail. This is crucial for compliance and helps in investigations if there is a temperature excursion.
- Validation: The temperature monitoring system must undergo validation to demonstrate that it operates consistently and accurately under intended conditions. This includes ensuring that the system accurately captures, records, and reports temperature data.
- User Access Controls: The system must implement controls to restrict access to specific users and ensure that users are authenticated before they can sign or modify any electronic records. This can be accomplished through role-based access controls (RBAC).
- Backup and Recovery: Organizations should establish procedures for regular data backups and a disaster recovery plan in case of system failures. This ensures that temperature data remains secure and recoverable.
- Training: Personnel must be trained on the proper use of the electronic temperature monitoring system, including understanding how to interpret data, respond to alerts, and maintain compliance with 21 CFR Part 11.
- Exception Reporting: The system should provide alerts and reports that help in identifying temperature excursions and other anomalies, which is essential for regulatory compliance and patient safety.
Summary
Overall, compliance with 21 CFR Part 11 is essential for any organization using electronic records, including temperature monitoring systems. It ensures that electronic systems are reliable, records are protected and can be audited, and signatures are secure. This is of particular importance in regulated industries like pharmaceuticals, where temperature monitoring is critical for maintaining product integrity. Organizations looking to be compliant need to have robust systems, policies, and training protocols in place.
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Your contact: Stefan Van Vooren