Designed for 21 CFR part 11

Enabling Traceability

User Management

Audit Trail

Data Integrity & Electronic Signatures

Symphony^® X instruments in cGMP facilities are used for synthesis of peptides required in applications such as clinical studies and neoantigen trials as well as cosmetic formulations.
For instrumentation in these environments, Title 21 CFR Part 11 (FDA) and Annex 11 (EMA) require safe and accurate data storage and traceability.
The software includes features that enable traceability via the following functions, for efficient reviews:
- User Management
- Audit Trail
- Data Integrity
- Electronic Signatures

user-management-chart

Predefined roles of Administrator, Designer, Runner, and Auditor with specified role rights, and individual users can be added and assigned to one of these roles.
Administrators can configure password length, complexity, frequency of change, and exclusion of used passwords
Administrators may also define the maximum number of failed login attempts and period of inactivity before users are automatically logged out and must re-enter a password.

software-audit-trail-illustration

A user or auditor can view synthesis run reports, instrument activity log files, user activity log files, and software log files
Export and print the full contents of all records including the audit trail
Detailed records of user and software activity as well as data from internal sensors monitoring fluid deliveries, heating, etc. also make these files useful diagnostics for instrument performance and troubleshooting.

data-integrity-electronic-signatures

Synthesis program, cleavage, and sequence files are protected and encrypted by document passwords and recorded as digitally signed PDFs using PDFTron technology.
Users can create a backup (restore point) on local or external drives, from which they can effectively restore the software.
Completed synthesis runs are signed off with a digital signature by the user who initiated the synthesis.
Signed synthesis reports contain the printed name of the signer, date, time when the signature was executed, and the reason for signing.

Symphony^® X - Learn more about Symphony X peptide synthesizer