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Plant  •  Animal  •  Stability  •  Toxicology  •  Batch Records

Batch Records
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The iAdvantage eStudy™ platform provides the Process Design Scientist with intuitive, logically organized tools to design electronic batch records (eBR). The eStudy Manager™ module is a user-friendly, web-based graphical interface for the definition of ingredients, processes, locations and samples.

Features of this module include:
  • User-built libraries of:
    • People and companies - including names, addresses, phone, etc.
    • Ingredients - including active ingredients, reagents, formulations, etc.
    • Processes - including steps in the production processes

  • Step-wise wizards for the creation of:
    • Process step descriptions
    • Sample lists - including generation of sample labels with barcodes

  • Data Collection Template Generator, which gives the Process Design Scientist control over the organization and presentation of the eBR and the data collection within it. These templates are easy to build and revise. Once built, the templates can be used repeatedly.
The data is collected using the eNotebook Manager™, a web-based electronic record of the process steps and results, or an electronic notebook for the batch. The Process Design Scientist generates these notebooks using the tools described above and publishes them to a URL. The individuals responsible for monitoring and executing the batch process access the notebook through a secure web-based environment via username and password permissions.

The batch record forms are completed while the user is actively online or can be downloaded to another workstation or tablet PC for data collection in a production or laboratory location. Data entries and revisions are tracked through an audit trail that allows auditing of the study data for Q.A., Q.C., and regulatory compliance (GLP, 21 CFR Part 11). In addition, data can be downloaded from instruments that may be monitoring and/or measuring specific process parameters or from instruments used to analyze samples collected during the process.

Sophisticated queries and/or statistical analysis can be applied to data within eStudy without the data leaving its secure validated environment with eStudy DataCipher™. If desired, the data can also be output to other statistical packages of the user's choice and the results returned to the database.

Data is then aggregated and reported using iAdvantage eStudy Publisher™ by authorized users whenever they choose - from anywhere in the world with a connection to the Internet. This unique tool allows the user to design his own report templates in the word processing software of his choice, including Microsoft Word, WordPerfect, etc. These report templates are then available to be used and revised as the needed. The reports are generated by selecting the Batch(es) and the report template. These reports can be generated in the user's choice of word processing or spreadsheet software.

By using eStudy, essentially any eBR can be designed, executed and reported in an efficient and consistent manner.