Idbs Bioprocess Execution System
- 1. Bioprocess Data Management Improving Compliance and Efficiency for the Development & Production of Biologic Drugs To successfully bring a biologic drug to the market is a complex and time consuming process, requiring interaction between multiple unit operations, groups and data sources. IDBS provides a flexible data management solution that meets the diverse demands of biologic drug development based on our extensive experience working with global biopharmaceutical and contract manufacturing organizations. The IDBS solution enables streamlined execution of optimized workflows, improved data access, sharing and reporting, and the process insight needed to successfully reduce the time and cost required to deliver new biologics to market.
- 2. Contact us > Website > Contact us > Website > Figure 1: Components of the IDBS Biopharmaceutical Data Management Solution
- 3. Contact us > Website > Contact us > Website > Managing Diverse Data Due to the complex nature of biopharmaceutical processes, companies invest many years of effort generating high-value data that is then locked in paper records, enterprise databases or Microsoft® Office file formats. This data is likely to be spread across multiple locations and stored in different formats, making it problematic to realize the full value of these important assets and maintain a holistic view of the processes being developed. The IDBS Solution offers a flexible and robust environment for the design, execution, capture, analysis, reporting and searching of process information, regardless of file type or location. This allows data to be stored in context and more effectively shared between groups, re-used as a source of corporate knowledge and used to monitor and improve processes. In doing so, it provides support for multiple biopharmaceutical operations: • Process design and execution • Analytical development • Process scale-up • Continuous improvement • Quality Assurance and Quality Control (QA and QC) The IDBS Solution creates a fully electronic development history record which supports the process through the development lifecycle, helping process engineers to develop robust, scalable and transferable bioprocesses. By integrating and optimizing workflows, the system enables more efficient process execution and reporting. Interactive reporting tools for monitoring process data, efficiency and quality provide the process insight required for a continuous improvement-led approach to biopharmaceutical development and production. This is further enhanced by the ability to drill down into process data and perform “root cause analysis”. Robust workflows ensure that Standard Operating Procedures (SOPs) are consistently followed or flagged, capturing data in a consistent way. The IDBS solution manages the flexibility required by development users, together with the more fixed nature of Good Manufacturing Practice (GMP) processes, in one integrated environment. Integration of existing data capture tools and disparate data silos allows users to bring enterprise data together in one interface for analysis, searching and submission ready reporting. • Formulations • Technology transfer • Clinical production A Spreadsheet Designed for Process Professionals Data capture is driven by a powerful and compliant spreadsheet designed from the ground up for bioprocess professionals. This module provides a familiar environment for the capture and analysis of process data with the benefit of inbuilt process intelligence and streamlined workflows. This module helps to significantly reduce the time spent capturing or manipulating process and analytical data. Form based views enable live process data capture thus eliminating the potential transcription errors and QA review associated with using multiple tools and paper records. All data entered into a spreadsheet form is stored in the database with its associated context. The system understands that a number is not just a number but that it represents an important part of your process such as yield or pH. This means that all data is fully searchable in context, enabling process professionals to look for trends in their data or check process performance by running a simple query.
- 4. Contact us > Website > Contact us > Website > A fully searchable audit trail is maintained, ensuring the validity of critical process data, with any changes clearly highlighted, helping to dramatically shorten the QA review process. Whether you are carrying out daily monitoring of your bioreactors, or capturing critical assay data, this module will help to speed up the data capture and will automate the downstream analysis and reporting. Figure 2: Data from fermentation & assay groups and from each of two duplicate runs are combined in one click. Hyperlinks in the report enable rapid access to the source data Direct data entry templates and forms enable structured data entry in both GxP and non-GxP environments. Templates enable standardized recording of data, ranging from observations to instrument data files. Forms can be used to capture batch records and deviations or to ensure that existing SOPs are adhered to throughout the development lifecycle. This reduces the GxP QA burden because deviations can be automatically highlighted through dashboards or email alerts, with the detailed context available for drill down. Workflow Execution
- 5. Contact us > Website > Contact us > Website > Automated Report Generation Figure 3 : A media preparation form that includes business rules. This form automatically retrieves information about the components from within the IDBS system or external databases and enables component traceability Information-rich reports can be simply created as required using drag-and-drop functionality, or specific report templates can be created to ensure consistency of reporting and comparability between results. Searching and report generation times are proven to be dramatically reduced, enabling rapid delivery of: • Development history reports • Technology transfer reports • Campaign summaries • Comparative analysis reports Navigate The IDBS Solution stores all of your high value data and knowledge in a secure, centralized database. The structure of the navigation hierarchy can be set up to align with the exact needs of your organization. The hierarchy structure is flexible and configurable, allowing it to adapt as your needs evolve. Security permissions and roles can be configured at any level in the hierarchy, ensuring that you have full control over your data and workflows at all times.
- 6. Contact us > Website > Contact us > Website > Search Powerful search capabilities provide enhanced visibility of all development, production and QA/QC data. All data is fully searchable, promoting re-use of high value knowledge and enabling better risk-based decisions and improved process insight. This ensures that there is a significant reduction in the “re-invention of the wheel” that is a result of not being able to quickly locate past data. Figure 4: Lots can be rapidly and easily compared across Unit Operations and against historical data Figure 5: All data recorded in E-WorkBook is searchable, including numerical and forms- based data Advanced task flow tools simplify communication between team members, groups and geographical sites. Clear and configurable notifications and time lines dramatically improve efficiency in activities ranging from electronic sign-off to technology transfer. All information relating to a task is made immediately available to the recipient, allowing them to complete the required actions without delay. Communicate
- 7. Contact us > Website > Contact us > Website > Figure 6: The task flow system enables users to communicate within the system Controlled, Secure and Compliant Fully searchable audit trails, combined with electronic and digital signatures and multi-level access control, ensure that you have full control over all of your data within one environment. Compliance data is linked to process data, helping to significantly improve quality assurance and audit efficiency across upstream, downstream and analytical development. The IDBS Solution is validated against 21 CFR Part 11 and is GxP compliant, operating seamlessly in both fully compliant and hybrid environments. IDBS’ Solution offers unparalleled protection of existing and future intellectual property assets while significantly reducing the time and effort required for QA review. The IDBS Bioprocess Data Management Solution provides one compliant portal for process development and biological production operations. By improving workflow execution, data and knowledge capture and accessibility, the IDBS Solution enables users to very simply answer who, what, when, how, where and why questions throughout the development lifecycle, helping to contract the development timeline. For the first time, scientific innovation, process execution, compliance and business performance can be seamlessly managed in one integrated solution. Figure 7: The IDBS DataLink tool can retrieve data from other systems (e.g. LIMS and other databases) for inclusion in a report e.g. to combine online and offline data
- 8. Europe Guildford (HQ) London North America Alameda, CA Boston, MA Bridgewater, NJ Asia Pacific Shanghai, China Melbourne, Australia www.idbs.com info@idbs.com Copyright IDBS 2010 All rights reserved Contact us > Website > Contact us > Website > +44 1483 595 000 +44 208 237 8440 +1 510 814 4900 +1 781 272 3355 +1 908 429 2900 +86 21 6469 1770 +61 410 708 052