Long-term human-readable study data archiving for Thermo Scientific™ Watson LIMS™

StudyGen 360 Plus Archive

StudyGen Archive is a light weight solution that satifsy regulatory requirements for study reviews. It makes data accessible to be further processed without knowledge of Watson LIMS or any other additional application.

By implementing StudyGen Archive data are available any time as flat files in a directory structure such as PDF/A, CSV and XML.

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Make the most of your Study Data Archive

It is no longer just about storing information for a specific period of time. Despite archiving, data should be easily and quickly accessible. Therefore data archiving must be flexible, user-friendly and human readable, while at the same time being audit-proof and capable of being integrated into the existing IT infrastructure.

With the use of StudyGen Archiving data will be accessible per experiment or any other area of interest. StudyGen Archive generates the complete study data documentation, as flat files in a directory structure such as PDF/A, CSV and XML. Thus it is the perfect solution for long-term archiving of study data in human-readable formats. StudyGen Archive ist designed for bioanalytrical and clinical studies, including validation studies. In Compliance with FDA Guidance für Industry: 21 CFR Part 11(11.10(b) and 11.50).

Compliant long-term availability for your Clinical Study Data

At a glance

  • Improve the quality of decisions by making up-to-date information based on historical data available to everyone who needs it

  • Enabling reuse of information regardless of geographic location

  • Reanalyzing old information with newer techniques or visualization techniques

  • Less time wasted searching for data sources: one search will deliver everything

  • Available in a human readable format

  • Extracting new value from old data sets

  • Including validation studies according to FDA Guidance für Industry: 21 CFR Part 11(11.10(b) and 11.50)

TOP StudyGen Plus Archive functions

Configurable

  • Scope – which file should be generated

  • Content – select which Watson LIMS information should be included

  • Extendable – including “manually uploaded files”

  • Interface with archival system

Human Readable

  • Represented in a PDF document stack

  • Structured based on RUN or STUDY

  • Including individual analyte Reports

  • Including calibration data

  • Including processing information

  • Including Audit Trail

Accessable Data

  • Represented in XML and /or CSV file stack

  • Structured based on RUN or STUDY

  • Including individual analyte data

  • Including calibration data

  • Including processing information

  • Including Audit trail

Configurable

  • Table representation identical to submission documentation
  • Consistens to submission documents:
    • Concentration significant figures
    • Statistics that is not stored in Watson LIMS
    • Statistics that is not available in Watson LIMS (on peak area/peak area ratios)
  • CSV and XML:
    • CSV more convenient when processing in Excel
      XML for other types of processing e.g. import to data warehouse

Data Integrity

  • Including file with checksum of all files (Hash-values of files)

  • Including validation studies according to FDA Guidance für Industry: 21 CFR Part 11(11.10(b) and 11.50)

Validation

  • up to data is ISO certified DIN EN ISO 9001:2015

  • StudyGen 360 Plus Archive is vendor qualified

  • Full validation documentation available based on internal standards

  • Make use of GAMP 5 approach:
    Vendor Audit
    Reference our documentation
    Minimal internal validation effort (only the business cycle testing)