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Take control of your compliance and data protection
AccuSEQ real-time PCR software offers robust data security and compliance features, including security, audit, and e-signature (SAE) capabilities to help you meet regulations such as 21 CFR Part 11. The software includes comprehensive tools for managing security settings, auditing changes, and handling e-signatures. Additionally, Thermo Fisher Scientific offers compliance services such as installation qualification and operation qualification (IQOQ) and computer system validation (CSV) to help streamline audits and support regulatory compliance. The AccuSEQ File Management Tool is designed to simplify data management, allowing you to backup, archive, and restore experiments efficiently.
The SAE feature of the AccuSEQ software supports you in meeting local regulations, such as 21 CFR Part 11. It includes options that help you easily organize and track your security settings:
- Security capabilities include username and password restrictions and security policies, such as password expiration and user account suspension
- Audit trail features automatically audit changes to experiments and modifications to settings in the SAE module, and sort and print audit records at the experiment and systems level
- E-signature options allow the selection of an e-signature mode (enable or disable), on-demand e-signature, e-signature settings, number of e-signatures required, and e-signature actions (review, approve, or sign off)
Other key benefits include:
- Database storage for improved data security
- Customizable user role and permission
- Two levels of auditing, including comprehensive reporting of audit events
Because AccuSEQ software is validated with real-time PCR systems like 7500 Fast and QuantStudio 5, 0.1 mL block systems, Thermo Fisher Scientific offers compliance services such as IQOQ and CSV that help you with compliance audits. For more information on compliance services, please contact your local sales or field support representative.
SAE features and compliance services
Software enhancements for the QuantStudio 7 Pro System
AccuSEQ software v4.0 adds SAE functionality not available in previous versions, including:
- Lightweight Directory Access Protocol (LDAP) support for single sign-on
- A single audit trail for both the instrument and the software
- SAE-specific archive and restore capabilities
- Export and import system configuration
- System and email notifications
- Username and password restrictions
- Customizable user roles and permissions
- Comprehensive reporting of audit events
- Comprehensive e-signature settings
- Database storage
- An audit trail for calibration (QuantStudio 7 Pro system only)
- Audits for runs that take place outside of AccuSEQ software (QuantStudio 7 Pro system only)
- Audit records
- User roles
- Reports
AccuSEQ software v4.0 shows a summary of the audit records.
AccuSEQ software v4.0 SAE Admin Console displays where user roles are defined and assigned.
Example of an audit report generated by AccuSEQ software v4.0.
Disaster recovery
The disaster recovery capabilities of AccuSEQ software v.4.0 are designed to protect and recover your data in the event of a major system failure or catastrophic event—a particularly important consideration in environments where data integrity and continuity are critical. The software’s robust mechanisms for data backup help protect your critical findings and information, support business continuity, enable regulatory compliance, and promote greater user confidence in your testing performance and data security.
Key features:
- Comprehensive data backup: Regular and systematic backup of all data generated with AccuSEQ software is securely stored and can be retrieved in case of a disaster
- Data recovery protocols: Established protocols for the recovery of data following a disaster include steps for restoring system functionality and data integrity
- System redundancy: Implementation of redundant systems supports operational continuity and reduces the risk of data loss
- User guidance support: Detailed guidance and support, including documentation and technical support, help users recover data and restore system operations
- Integration: Comprehensive disaster recovery capabilities are easiliy integrated with AccuSEQ software and work with the software’s SAE administration console
AccuSEQ File Management Tool
The AccuSEQ File Management Tool is a specially designed feature that allows non-IT and database customers to manage their data in the AccuSEQ database with a simple user interface. The File Management Tool is built to help with backups, archiving, file access, as well as security. It includes advanced database storage and rapid recovery capabilities to help protect data even in the face of catastrophic computer loss. Stay confident and compliant with AccuSEQ software.
Data in AccuSEQ software v4.0 can be backed up in three ways:
AccuSEQ File Management Tool: Use the tool to back up, purge, or restore selected experiments in a date range or to back up all data stored in the AccuSEQ software v4.0 database.
- Back up selected experiments in a date range or back up all data stored in the AccuSEQ database
- Purge selected experiments by permanently deleting them from the database
- Restore selected experiments in a date range or restore all data stored in the AccuSEQ database
Manual backup: Use export functions in the software to manually back up after each experiment. You can:
- Export the experiment data to an EDS file
- Export the experiment and audit reports to PDF files
- Export new templates to an EDT file
- Export SAE audit records if changes were made
Manual export of EDS, EDT, and PDF files can take several minutes per experiment. Only EDS and EDT files can be reimported. PDF files cannot be reimported.
Backup and restore utility: Use to backup experiments stored in AccuSEQ software v4.0
Computer System Validation (CSV)
This comprehensive document starts with a master validation and ends with a summary report. The Thermo Fisher Scientific CSV consulting service aims to develop and produce results in documentation form as tangible evidence, to help confirm that all software features within scope of data security, auditing, and e-signature are suitable for intended use.
The CSV offering includes complete or partial consulting services with 12 industry-standard validation documents and execution for collection of objective evidence:
| Validation plan | OQ with objective evidence |
| Validation Risk Assessment (RA) | Performance qualification (PQ) with objective evidence |
| User Requirements Specification (URS) | Traceability matrix |
| System Configuration Specification (SCS) | 21 CFR Part 11 / Annex 11 / GAMP™ 5 Assessment |
| Validation test plan | Quality assurance review |
| IQ with objective evidence | Validation summary report |
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