Data Integrity

MHRA: ‚GxP‘ Data Integrity Guidance and Definitions, March 2018

FDA: Data Integrity and Compliance With Drug CGMP, December 2018

According to the FDA, data integrity refers to the completeness, consistency, and accuracy of data. Data should be attributable, legible, contemporaneously recorded, either original or true copy, and accurate as well as complete, consistent, enduring and available (ALCOA+).

By design, iStudyReporter is addressing these requirements of the guidances.

End-to-end data integrity is a build-in feature of iStudyReporter by having

-    validated interfaces to Watson and other LIMS systems (Remote Collector),
-    the table sections in the created documents protected
-    created documents being transferred to eCTD systems using native interfaces

EBF Poster 2019

iStudyReporter supports the current FDA Guidelines

iStudyReporter Bioanalytics is already supporting the current FDA and MHRA guidelines and will lift your lab to the next level of automation. No need to wait for a Thermo Watson upgrade. iStudyReporter is the industry standard for the automated creation of submission documents from Thermo Watson LIMS.

FDA and MHRA have published new guidelines. The guidelines are listing in the following section.

Bioanalytical Study Reporting

FDA: Bioanalytical Method Validation, May 2018
Most requirements can be met with the current combination of Watson 7.4 and iStudyReporter:

Immunogenicity Study Reporting

FDA: Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection, January 2019

Even with Watson 7.3 and iStudyReporter, many of the requirements are addressed.

iStudyReporter product family


Gives you an efficient solution for generating bioanalytical study reports using Thermo Scientific™ Watson LIMS™.

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Gives you an integrated solution for simple and fast approval report generation using a stability LIMS such as Sample Manager, LabWare, LabVantage.

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Gives you a unifying solution for generating complex study reports from a variety of data sources.

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up to data is certified by DQS to the following standards: ISO 9001:2015 (Certificate-Reg.No: 272524 QM15)

Besides the implementation of the above-mentioned ISO-Standards, and as the result of many years experience, we are especially aware of the standards and regulatory guidelines that our customers need to conform to. In the laboratory environment these include, among others, GAMP-Guidelines and the GxP-Standards.

Do you have any questions about iStudyReporter?

Need more information, or would you like to arrange a meeting with us?

We would be pleased to help you out, and would welcome the opportunity to talk to you.