About Aegyris™

A Comprehensive software solution for the bioanalytical laboratory

Somru scientist have developed software solution to enable bioanalytical laboratories to meet rigorous scientific and regulatory requirements. Aegyris streamlines assay design and execution, data analysis and ensuring 21 CFR Part 11 compliance.

The web front-end of Aegyris provides a rich user interface for data analysis and visualization. It drives laboratory productivity, ensure compliance, and streamline processes by using simple easy-to-use intuitive wizard-based interface.

Aegyris™ is designed to enable bioanalytical scientists to perform method validation, statistical analysis, and validation workflow management in a streamlined and regulatory compliant manner. The IntelliLab module within Aegyris is designed to streamline day to day laboratory activities involving inventory, sample tracking, and electronic laboratory notebook (ELN).

Aegyris™ can save up to 70% of time and costs in method validation support activities when implemented as designed.

A Comprehensive cloud based software solution for the bioanalytical laboratory.

  • A Comprehensive software platform for bioanalytical laboratory
  • Aegyris™ contains following functionalities:
  • Method Validations
  • PK, Immunogenicity, Biomarker (including multiplexing) and Biosimilar
  • Productivity Tools (IntelliLab)
  • Sample tracking using RFID
  • Inventory management
  • eLabEx (Electronic Lab notebook)
  • Artificial intelligence driven data analytics
  • 21 CFR Part 11 compliance
  • Modules that are designed independently as micro-service for inter-operability
  • Scalability
  • Direct link to various LIMS or data system
  • Aegyris Bioanalytical

    Biomarker

    Multiplexed biomarker assay data analysis accurately... read more

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    PK - Pharmacokinetics

    Automated generation of validation experimental design including plate maps... read more

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    Trending

    Proactive monitoring of assay performance and detecting potential assay issues before they fail... read more

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    Immunogenicity - Anti Drug Antibodies

    Calculate immunogenicity cut points (screening, confirmatory and titer) in one click... read more

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    Biosimilar

    Perform parallelism testing which is critical to establishing analytical similarity... read more

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    Aegyris™ Productivity

    icon   Smart Inventory

    Smart real time inventory tracking and critical regent life cycle management... read more

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    icon   RFID Sample tracking

    Bioanalytical module contains 5 component (PK, Immunogenicity, Biomarker, Biosimilar, Trending) for streamlining... read more

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    icon   eLabEx

    The electronic worksheet allows real time critical assay data capture and management backbone of any scientific experiment in your lab... read more

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    State of The Art AI Engine

    Bioanalytical module contains component streamlinin data analysis

  • Statistical analysis engine
  • Uses standard R library package
  • R library packages being validated by multiple well recognized organization
  • Communicates with Aegyris Base via ESB using HTTP API
  • Automated identification of discrepancies between Validation plan and report
  • Automated warning and error notification for deviation from regulatory guideline
  • Powerful Reporting

    Bioanalytical module contains 5 component (PK, Immunogenicity, Biomarker, Biosimilar, Trending) for streamlining data analysis.

    Bioanalytical module contains 5 component (PK, Immunogenicity, Biomarker, Biosimilar, Trending) for streamlining.

  • Report is configurable and customizable
  • Val Report contains 3 types of data
  • Free form text
  • Non-editable template information (e.g. compliance statement)
  • Result table from Aegyris™ data analysis
  • Will need data tables and plate maps to construct appropriate template
  • Report can be exported in various format (e.g. MS word or PDF)
  • Ready for Your Audit

    The audit trail is automated, secure (can’t be edited), contemporaneous, traceable, and archived

    The audit trail is automated, secure (can’t be edited), contemporaneous, traceable, and archived

  • The audit trail is automated, secure (can’t be edited), contemporaneous, traceable, and archived
  • Audit trail content includes – identification of user, date and time stamp, record Id, original value, new value, reason for change and electronic signature
  • Configurable data retention policy
  • Archiving
  • Data is locked and stored in archive directory with limited access
  • Ability to load data on application with limited user access (read only) upon request and approval
  • Ability to integrate with third party document management software
  • CONTACT US

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