AccuSEQ Real-Time PCR Software

The AccuSEQ software was designed to facilitate the data interpretation of essential tests required for GMP manufacturing, including in-process testing and lot-release testing.

• Integrated, easy-to-use interface allows for consistency across multiple data applications and reduces the time needed to train your team
• Single software platform for all current and future resDNASEQ, MycoSEQ, and ViralSEQ real-time PCR assays, as well as custom experiments
• Security, audit, and e-signature capabilities to help enable 21 CFR Part 11 compliance
• Available for 7500 Fast and QuantStudio 5, Block PCR instruments for easy integration of SEQ solutions into your current QC laboratory
• Flexible throughput of 10–500 samples per week
• Complete traceability with assay specific output, eliminating manual calculations
• Comprehensive data management and reporting features

Thermo Fisher Scientific offers an integrated solution for the entire analytical workflow, consisting of sample prep, SEQ assays, qPCR Instrument and the AccuSEQ software. During sample preparation, enable reliable, consistent recovery of your target DNA and RNA with Thermo Fisher’s proven PrepSEQ chemistry. There are various assays to detect impurities, identify contamination, and quantify titers using the resDNASEQ, MycoSEQ, and ViralSEQ family of assays. Finally, you have the AccuSEQ Software to run the assays on the 7500 Fast/QuantStudio 5 instruments and to analyze the data from the instrument to produce actionable results.

For rapid and accurate mycoplasma detection, the AccuSEQ software offers a plug-in analysis module for automated presence or absence calls when using the MycoSEQ Mycoplasma Detection system.

Key features and benefits:

• Optimized and validated for the MycoSEQ Mycoplasma Detection assay
• Automated detection of PCR inhibition in sample wells
• Automated detection of discriminatory positive control (DPC)
• Robust data analysis parameters for the MycoSEQ Mycoplasma Detection assay
• Flexibility for experiments; call settings may also be modified to meet the specifications of individual laboratories

The AccuSEQ software offers factory default templates to facilitate experiment set up for the accurate and sensitive quantitation of host cell DNA impurities in both the purification process and in drug substance samples.

Key features and benefits:

• Streamlined resDNASEQ experiment setup (using factory default templates) and data reporting
• Automatic calculations of the resDNASEQ standard curve with curve fitting parameters
• Accurate quantitation of samples with % CV
• Computation of key metrics including % Recovery, Total DNA in pg/mL, and pg DNA/mg Protein
• Flexibility for custom experiments to meet the specifications of individual laboratories
• Customizable output layout that can be exported to a variety of formats
• Comprehensive reports which help eliminate the need for Excel sheets for calculations and preserve the audit trail
   

For rapid and accurate sterility testing, the AccuSEQ software offers presence or absence calls when using the SteriSEQ Rapid Sterility Testing Kit, allowing for easy analysis.

Key features and benefits:

• Automated analysis with presence/absence calls
• Bulk edit feature to allow for custom rule edits
• Discriminatory positive control to help eliminate false positives
• Predefined templates to allow for streamlined experiment setup
• Comprehensive reports which help eliminate the need for Excel sheets for calculations and preserve the audit trail

The AccuSEQ Software v3.2 shows the “automated presence or absence calls” of sterility testing.

Learn more about the SteriSEQ Rapid Sterility Testing Kit ›

For rapid and accurate MMV and vesivirus detection, the AccuSEQ software offers:

• Robust, optimized, and validated system—data analysis designed for use with ViralSEQ Detection Systems
• Automated detection—rapid assessment of PCR inhibition in sample wells
• Analysis options—identify true positive from false positives with discriminatory positive control
• Flexible call settings—meets specifications for unique lab requirements
   

The AccuSEQ software offers factory streamlined experimental set up for the accurate and sensitive quantitation of Sf-rhabodvirus contamination in both the purification process and in drug substance samples.

Key features and benefits:

• Streamlined experiment set-up—use factory default templates for easy data reporting
• Automated calculations—help eliminate the need for Excel sheets for calculations and preserve the audit trail
• Comprehensive reports—compute key metrics including percent recovery, total RNA in pg/mL, and pg RNA/mg Protein
• Flexibility—easily adjust for custom experiments to meet the specifications and reporting needs
   

Learn more about the ViralSEQ Virus Detection and Quantitation Systems ›

There is also the custom experiment mode (“Create New”) where users can use the AccuSEQ software to create custom experiment setups. The custom mode guides the user through the experiment properties, qPCR run method details, and plate setup where there are easy-to-use tools for defining and setting up standards, controls, and unknowns. This custom workflow also supports ViralSEQ Mouse Minute Virus (MMV), vesivirus, and resDNASEQ SF9-Baculovirus duplex assays.
 

The AccuSEQ Software produces customized output for SEQ assays, helping users to export complete, traceable, and simple outputs, greatly streamlining the analysis process. Rather than outputting Ct and requiring further downstream calculations, the customized output feature allows you to have a specialized output to match your needs. For example, the LentiQuant physical titer outputs the viral particles/mL that help determine the titer of lentivirus in viral supernatants and purified viruses.
 

Security, audit, and E-signature (SAE) is a key feature of the AccuSEQ software as it supports our customers in meeting their local regulations like 21 CFR Part 11 compliance. The software security, audit, and electronic signature (SAE) manager includes options that let you easily organize and track your security settings, such as:

• Security—username and password restrictions, and security policies such as password expiration and user account suspension
• Audit—automatically audits changes to experiments in the AccuSEQ Software and modifications to settings in the SAE module, and sorts and prints audit records at the experiment and systems level
• Electronic signature—selection of an electronic signature mode (enable or disable), on-demand electronic signature, electronic signature settings, number of electronic signatures required, and electronic 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

Since AccuSEQ software is validated with respective real-time PCR systems (7500Fast and QuantStudio 5, 0.1mL block), Thermo Fisher Scientific offers compliance services like IQOQ (installation and operation qualification) and CSV (computer system validation) services that save customers time and money with compliance audits. For more information on compliance services, please contact your local sales or field support representative.
 

This comprehensive document starts with a master validation and ends with a summary report. The Thermo Fisher Scientific Computer System Validation (CSV) consulting service develops and produces results in documentation form as tangible evidence, assuring that all software features within scope of data security, auditing, and e-signature are suitable for intended use.

The AccuSEQ File Management Tool is a specially designed feature that allows non-IT/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.

Data in AccuSEQ Real-Time PCR Software v3.2 can be backed up in three ways:

AccuSEQ File Management Tool—Use the tool to backup, purge, or restore selected experiments in a date range or to backup all data stored in the AccuSEQ Real‑Time PCR Software v3.2. Use the tool to:

• Backup experiments—Backup selected experiments in a date range or backup all data stored in the AccuSEQ Real‑Time PCR Software v3.2 database
• Purge experiments—Permanently delete selected experiments from the database
• Restore experiments—Restore selected experiments in a date range or restore all data stored in the AccuSEQ Real‑Time PCR Software v3.2 database.

Manual backup—Use export functions in the software to backup after each experiment. You can:

• Manually export the experiment data to an EDS file
• Manually export the experiment and audit reports to PDF files
• Manually export new templates to an EDT file
• Manually 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 Real‑Time PCR Software v3.2