Long term human-readable Study Data Archiving for Thermo Scientific™ Watson LIMS™

StudyGen 360 Plus Archive

StudyPlus 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 StudyPlus 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 StudyPlus Arche data will be accessible per experiment or any other area of interest. StudyPlus 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. StudyPlus 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 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 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 StudyPlus Archive features

Configurable

  • Scope – which file should be generated.

  • Content – select which Watson LIMS™ information should be included.

  • Extendable – including “manually uploaded files”.

  • Interface with archive 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.

Data Representation

  • 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)

Your contact person

Stefanie Kirstein
Head of Sales – Customer Engagement Manager (CEM)

t + 49 6732 9490-57
e sales@uptodata.com