Accuracy
Today’s Final Report Generation Issue
Copy/paste errors resulting in QC or QA events are generally known to the bioanalysis community as a nagging issue in any manual final report generation process.
So much so, that it has come to the attention of regulators.
Automated report generation systems ensure accurate and consistent insertion of study- and table-specific variables in the final report.
What is ICH M10?
The final version of ICH M10 “Bioanalytical Method Validation and Study Sample Analysis” was adopted on May 24, 2022. The guidance is intended to provide industry with harmonized regulatory expectations for bioanalytical method validation of assays used to support regulatory submissions.
Adapting to ICH M10
Bioanalytical method validation of biologic sample assay measurements in nonclinical and clinical studies is a critical part of any drug or biologic development program. Adaptation world-wide will lead to more harmonized results in a global market, making it easier for one regulatory body to accept the results of another regulatory body.
The StudyDoc Solution
StudyDoc retrieves all study- and table-related raw data from the Thermo Scientific Watson database. It also accurately and consistently generates table-specific summary tables located in the Final Report body section. This allows labs to almost immediately produce a consistently formatted, hyperlinked, and accurate draft GLP Final Report upon study completion meaning Final Reports can be issued more quickly. This also allows labs to complete more studies in the same given time frame.
No more cut-and-paste
errors
Keeps you compliant
with ICH M10 Step 5
Provides accuracy
and precision
Interested in a Demo?