Symphony®X Multichannel Peptide Synthesizer

Enhance research, optimize, and increase production flexibility.

Compliant Software under 21 CFR Part 11

Ensure compliance through effective review via audit trails and reporting features. Retrospectivity

User management includes password management support and login rules.

Compliant with 21 CFR Part 11 Electronic signature

Ensure traceability

Symphony in a CGMP facility ^® The X instrument is used to synthesize peptides required for a variety of applications, such as clinical studies, neoantigen assays, and cosmetic formulations. Instruments employed in these environments must provide secure and accurate data storage and traceability. Regulatory agencies—including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency—require specific controls and documentation for software involved in electronic data processing. Part 11 of the 21 CFR is a component of federal regulations that outlines the FDA’s requirements for electronic records and electronic signatures, while Annex 11 of the European Union represents a similar set of European regulatory provisions.

To meet these requirements, SymphonyX software conducts effective reviews through the following features, enabling traceable performance!

User Management
Audit trail
Data integrity
Electronic signature

Compliant Part 11 of 21 CFR and IQ/ OQ

With training provided by qualified personnel, comprehensive quality management systems—including appropriate documentation covering installation qualification and operational qualification (IQ/OQ)—and software that complies with the requirements of 21 CFR Part 11, SymphonyX users can meet and exceed regulatory standards.

The IQ/OQ support service verifies and documents whether the supply, installation, and operation of your instrument comply with GPT specifications. GPT-certified field service engineers will inspect critical components to ensure the system operates properly during automated synthesis processes and provide accompanying documentation to help you meet regulatory requirements.

User Management

Administrators can configure passwords by specifying the password length, complexity, modification frequency, and excluding previously used passwords. Administrators can also set the maximum number of failed login attempts. After a specified (and configurable) period of inactivity, users will be automatically logged out and must re-enter their password to log back into the software.

A password is required at least when creating new or editing existing program or sequence files. In addition, administrators can also specify more stringent control measures.

Audit trail

An audit trail is an electronically stored data file that includes timestamps and is tamper-proof, providing detailed records of all system events and modifications. The SymphonyX software enables users or auditors to view composite run reports, instrument activity log files, user activity log files, and software log files. All recorded content, including the audit trail, can be exported and printed.

Detailed records of user and software activities, as well as data from internal sensors (monitoring fluid flow, heating, and other processes), also provide these documents with practical diagnostic information for instrument performance and troubleshooting.

Data integrity

The synthesis program, cleavage, and sequence files are protected by document passwords and encrypted, and then recorded as digitally signed PDFs using PDFTron technology.

It is necessary to develop backup, archiving, and recovery strategies to ensure that data can be reconstructed in the event of an unexpected data loss. SymphonyX software enables users to create backups (restore points) on local or external drives, thereby effectively restoring the software.

Electronic signature

An electronic signature serves the same purpose as a handwritten signature. To meet the FDA’s requirements for using electronic signatures, software must employ at least two distinct authentication components, such as an identification code and a password. When a new user is added to the system, the system will verify that the user has a username, a username-password combination, an email address, and a legitimate name for digital signing.

The completion of the synthesis run is acknowledged by the user who initiated the synthesis. This is reflected in the synthesis run report as a digital signature. The signed synthesis report includes the signer’s printed name, the date and time of the signature, and the reason for signing.

Audit Support Documentation

In addition to training records, feature specifications, and user guides, audit support documentation can also be provided, detailing how individual software features correspond to the specific requirements outlined in Part 11 of 21 CFR.

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