INTEGRATED INFORMATICS SOLUTION continued


notebooks (ELNs), laboratory information management systems (LIMS), and other scientific applications. This type of system is designed to enable the transfer of data and information across domains to enable “cross-talk” and real organizational productivity improvement.


In a regulated environment, scientific documentation requirements change dramatically as a product moves from R&D to commercialization. What was relatively open and free-form in drug discovery becomes more structured for QC in manufacturing. Processes are driven by the need for compliance with regulations, Standard Operating Procedures (SOPs), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and other guidelines. When organizations can electronically capture and transfer structured and unstructured data in a single system across the product lifecycle, management gains insight into process and product quality. Data can be leveraged both upstream as well as downstream in the product development process.


2. Follow ISA-88 and ISA-95 standards ISA-88 is an international standard for batch control in manufacturing. ISA-95 is the standard for the integration of enterprise and control sys- tems.5


Together these standards pertain to the way software is designed


in order to allow for data and technology transfer between the various domains in product development (Figure 2).


Quality by Design (QbD) initiatives are demanded by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA), stressing that quality be built into a product as a fundamental part of the development process from the earliest phases of the product lifecycle to final commercialization using standardization for consistency and control.6


of enterprise data in a centralized database. This type of standardization facilitates integration and speeds data mining and transfer.


Using the ISA-88 and ISA-95 standards in the upfront design of a system creates a powerful data and method exchange capability. This proficiency reduces the time to reimplement a given method by enabling electronic technology transfer, thereby reducing the time, costs, and other burdens of traditional technology transfer while simultaneously providing the process definitions for QbD initiatives.


3. Include regulatory compliance requirements In the life science industries, compliance with regulatory requirements is mandatory. As a new product moves from R&D through commercialization to become available for sale in the U.S., the FDA requires that electronic records be maintained throughout the process along with electronic signatures and audit trails to ensure data integrity and compliance.7


In R&D, documentation and workflow management systems like ELNs need to have an open structure to handle experimental data, including the ability to adjust scale, reorder process steps, and substitute compo- nents in creating a formulation. Scientists can capture both the processes they perform and the interpretation of experimental results. However, in a regulated environment, open structure presents a compliance liability. A system must be capable of handling highly structured operational protocols (instrument records, SOPs, etc.) within a validated system. This applies to operational reporting as well as data mining and technology transfer. Any software application platform used across domains needs to be flexible enough for R&D while also being compliant with regulatory requirements to ensure data integrity throughout a product lifecycle.


The ISA-88 and/or ISA-95 process definitions were derived from


QbD initiatives to help companies embed quality into their processes and mitigate risks. Structures used in manufacturing—system control, process management systems, and business systems—are defined in the software using ISA-88 and ISA-95 standards, allowing for uniform storage


Quantifiable benefits of an integrated


informatics solution By electronically capturing and accessing data from early design and op- timization experiments through commercialization, drug development companies can examine and optimize their own process and product quality. The Accelrys Process Management and Compliance (PMC) Suite (Accelrys, San Diego, CA) is designed to track and trace materials, samples, instruments, specifications, reports, and data in GLP- and GMP-compliant environments and has validatable-ready connections with instruments, ELNs, LIMS, and other applications. It is based on the Accelrys Enterprise Platform (AEP), which allows for easy integration of Accelrys applications as well as systems from other providers.


Figure 2 – ISA-95, the international standard for an automated interface between enterprise and control systems, acts as the operating framework for manufacturing. ISA-88 defines the physical model and is especially focused on the level of the process cell and the lower levels.


The PMC Suite streamlines data access and technology transfer by stan- dardizing data capture using a single common data structure and format following the ISA-88 and ISA-95 standards. Outputs and reports can be exported to web-based services enabling access and display of data in the way most appropriate for the various domains. Because business rules and quality standards are built into the PMC Suite as well as the AEP, companies can ensure that information complies with the necessary standards and regulations as it moves across the development continuum. The single platform design enables flexible data mining in early R&D as well as the compilation of more structured outputs and documents required for later regulatory submissions.


AMERICAN LABORATORY • 22 • JUNE/JULY 2014


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