The document discusses a data management solution from IDBS for biopharmaceutical companies. It manages diverse data from multiple sources and formats. The solution improves compliance, streamlines workflows, enhances data access and reporting, and provides insights to reduce drug development time and costs. It enables end-to-end management of the complex biologics development and production process.

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.

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Figure 1: Components
of the IDBS
Biopharmaceutical
Data Management
Solution

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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.

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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

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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.

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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

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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
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