LIGHTHOUSE DRUG STABILITY REPORTING APPLICATION
REDUCE TIME SPENT ON DATA VERIFICATION
The Lighthouse Drug Stability (DS) Reporting Application supports the creation and maintenance of dynamic stability reports that grow over time as initial and future testing data are added. Stability reports are used to support initial filings as well as annual product updates and reviews. Lighthouse DS uses Cognition’s unique approach to creating structured data and content, reusable report templates, and comprehensive workflow controls to increase confidence in report accuracy and increase credibility with health authorities. Reports from Lighthouse DS are used to populate various internal reports and Module 3 Dossier sections such as 3.2.S.7.3 and 3.2.P.8.3.
“I like to tell the story that it took us maybe 5 or 6, 2-hour meetings to assess [drug name] with our previous process. With Lighthouse we are able to complete our work with two meetings in one week.”
– SENIOR SCIENTIST, PHARMACEUTICAL COMPANY
STRUCTURED DATA FOR BETTER DRUG STABILITY REPORTING
Our application is built with the concept of structured data items as the initial infrastructure from which to generate complex relationships, data tables, and reports. This enables pharmaceutical companies to reduce the time and resources required to complete critical reporting activities for both internal consumption and health authority submissions. Automated creation of data-heavy tables eliminates errors resulting from manual table generation.
Key Features
Quality-Enforced, Source-Agnostic Data Imports From LIMS, ELN, SAP, And Others
The Lighthouse DS application uses source-agnostic data import to create individual, structured data items to render Studies, Parameters, Storage Conditions, Time Points, test results, data tables, documents, and overall reporting projects. The application supports three import types. Initial imports take all data from source systems into Lighthouse and generate unique structured data items. Later imports into the same project provide the user a choice between overwriting data or merging data. Merging imports new timepoint data and fills in data gaps and does not overwrite any existing data. Overwrite imports all data and replaces any existing data with new values.
Structured Parameters
Lighthouse DS Parameters are fundamental data items as they represent the actual testing information for stability studies. Parameters may decompose into sub parameters as required. Parameters and sub parameters use Lighthouse data mapping to combine information about storage conditions, time points, and test results. Parameters retain comprehensive, “life-long” audit logs of all activity. Parameters can be used in multiple stability reports over any period of time.
Every parameter is a unique, structured data item in Lighthouse. Parameters have “home pages” where authorized users can make decisions about how parameters are displayed and rendered within data tables. Settings include numerical thresholds, significant figures, entered versus displayed values, time points displayed, parameter ordering, etc. Settings on parameters drive how the parameters appear in data tables. Lighthouse never alters any actual source data values.
Reusable Study Data and Report Templates
Lighthouse DS supports an unlimited number of reusable data table, report, and project templates. The off-the-shelf Drug Stability project template includes report documents for both Large Molecule and Small Molecule products as well as Shelf Life for Large Molecule. It also contains all of the imported studies with associated parameters and results.
Drilling down further, users can create and maintain multiple report templates to satisfy requirements for internal reporting needs and health authority submissions. The off-the-shelf Drug Stability report template for Small Molecule contains the data tables. Users can create many more data tables and sections as needed for different reports. Other sections of the report are completed through a combination of auto-insertion (from Studies and Data Tables) and direct authoring by the user.
Automated Generation of Data Tables
Data tables are at the core of the Lighthouse DS application. Tables are carefully structured, automatically generated, reusable parts of report templates. Lighthouse DS supports the definition of how tables are structured so users do not manually build tables. Instead, users choose a set of parameters which Lighthouse DS uses to automatically generate the appropriate data table.
The software also supports creating and maintaining footnotes. While footnotes may not at first seem to be a complex matter, some tables and document sections require many, which often change or need to be updated over time. As users add, edit, and remove footnotes, the software automatically updates them as needed and re-sequences footnote numbers and letters to ensure all footnotes are correctly ordered and identified.
Adaptive to Business Processes and Job Aids
Lighthouse DS supports the definition and enforcement of prescribed business processes to generate structured data tables and documents for internal consumption and external submission. Source-agnostic data imports can apply import rules on incoming data. Users cannot alter actual source data values. Work Instructions and Job Aids can be embedded into all Lighthouse templates. Comprehensive workflow and roles ensure a clear chain of evidence with electronic signatures. Customer-definable, reusable data table and report templates can be created and altered only by administrative actions with audited controls.
WHY CHOOSE LIGHTHOUSE FOR DRUG STABILITY REPORTING?
The Lighthouse Drug Stabililty Reporting Application provides significant reduction in the burden of creating structured reports, allowing scientists to spend more time doing science and less time creating, verifying, and correcting errors in report documentation.
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