Features

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Administration:
Project design definition:

  • study codes
  • analytes names, matrices
  • regression models, weighting parameters
  • acceptance criteria (chromatogram acceptance, batch acceptance, reassay acceptance)
  • user assigned to project: principal investigator, responsible analyst(s), QC reviewer(s) etc.

Administration of users and roles implementing user permission structures for clear workflows 
Administration of departments and instruments
Long term stability planning
Instrument capacity monitoring

Audit trail / Electronic Signatures / Electronic Archive Support
Audit trail, electronic signatures and electronic archive functions implemented to support 21 CFR Part 11 requirements 

Data Import:
Secure import of chromatographic data or calculated concentrations with audit trail including database storage of the original files.

Calculations: 
All calculations performed within the database using identical algorithm independent on individual analytical technique or instrument settings!

  • linear/quadratic/logarithmic regression using peak areas or peak heights, with/without weighting
  • back-calculation of QC and unknown samples concentrations
  • statistical evaluation of Standard, QCs and stability results
  • direct import of concentration data is also possible

Monitoring of all results for correctness / Acceptance checks:
Project data, data of the analytical batches, the individual (chromatography) data as well as the calculation results are always automatically checked against all pre-defined acceptance criteria.

Data processing – the workflow – is supervised by dbLabCal:
Hierarchical data management:

  • release of individual data (chromatograms) using individual result/data flag
  • release of individual batches by changing the batch status
  • release of the whole project by changing the project status (database lock)

Data processing is based on the pre-defined acceptance criteria and current user permissions in the project.

Data processing is possible only with appropriate user permission level and only if respective acceptance criterion is also fulfilled!

Interface/Data Export:
Data export possible at any time using Windows clipboard
Data export into various pre-defined ASCII files (e.g. for further processing in SAS®)
Fully automatic export of all data into MS Word – automatic report writing including full control of document formats!

Chromatography data analysis:
Display and export of retention times, peak heights and peak widths of all chromatograms (e.g. for quick verifying of peak integration parameter, peak assignment, etc…)

Selection of specific chromatographic data from the database (e.g. peak areas of all QCs to demonstrate their stability throughout the duration of measurements…Quality control charts)

Two Languages
dbLabCal works in two different user-defined languages, switchable at any time.