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Every laboratory submitting BA data to a regulatory agency must comply with a number of guidelines. With all laboratories working differently, the regulatory reporting process can be hugely resource intensive.
The IDBS Bioanalysis Solution can help save vast amounts of resource by collating data across multiple runs, eliminating the need for paper recording and reducing the need for error-prone manual data input. Validated templates provide secure links between the original data and any final calculations for ease of audit, with data recorded as securely as traditional paper records.
The IDBS Bioanalysis Solution is geared towards improving compliance and reducing QC burden.
Mandatory fields, acceptance criteria and direct transfer of data and values from balances and pH meters, ensure high-quality data is entered at the time of study execution. Our bioanalytical solution eliminates transcription errors by directly accepting raw data from a plate reader and performing statistical analysis and curve fitting within a workflow. QC of a study can move from manual checks of date or time stamps, cross-reference checks of metrology logs, expiration date checks for all materials used and revisiting calculation to an exception-based auditing methodology.
The IDBS Bioanalysis Solution enables you to create and manage electronic methods to drive all aspects of sample analysis, including sample preparation, instrument set-up and post-run scientific review. Our bioanalytical solution can also consolidate run data from your LIMS and facilitate the compilation of study reports.
Along with on-premise and hybrid client options, the IDBS Bioanalysis Solution can be deployed in a controlled, fully validated GxP Cloud environment – providing security, eliminating paper, reducing total cost of ownership (TCO), and reducing time-to-value (TTV) for you. The built-in audit log monitors data input and GxP settings can be adjusted to full compliance mode where authentication credentials are mandated at each step of the process – letting you get back to what you do best: science.
IDBS’ family of desktop and web-enabled software products are built on a cross-disciplinary electronic laboratory notebook (ELN). Our platform is proven to increase productivity for any organization engaged in research and development.
Built on a set of bioanalytical workflows that incorporate best practices, the IDBS Bioanalysis Solution helps you go beyond creating a digital version of your paper records. It can revolutionize the way you run your bioanalytical operations. Sitting at the heart of your lab ecosystem, the IDBS Bioanalysis Solution can integrate with and ‘pull’ data from existing LIMS, balance instruments, metrology systems, ERP systems and document management systems. This single portal approach enables you to simplify the management of your bioanalysis operations, improving your project planning and scheduling capabilities.
Labs that use industry standard bioanalytical LIMS, like Watson, can leverage tight integrations to ensure project and study hierarchy and attributes (project name, ID, analyte information, etc.) are automatically created and updated within our solution. Sample lists and run information can be retrieved and stored for easier referencing at the bench, such as in a specified plate format. Finally, result data can be transferred from LIMS, or even the analytical instrument, to our spreadsheet for downstream calculations and reporting.