options. Thermo Fisher offers the Designer application, which enables creation of submissions like the Investigational New Drug Application (IND) and the New Drug Application (NDA). Starlims offers HL7, ASTM and OPC support. Advanced file parsing is available with its SDMS system, to allow semi-structured sample submissions. SAP offers EBR capability as part of the QM functionality. For EBR functionality, Siemens recommends the implementation of Simatic IT Unilab LIMS together with Simatic IT Production Suite (Manufacturing Execution System - MES), as the e-batch records consist of production operations data and quality operations data. LabWare’s Pharmaceutical Template provides out-of-the-box capability, and ready formatted reports for product batch release and stability data. These reports can be output in ‘electronic format’ such as PDF and XML.
filling the knowledge gap The Guidance for Industry ICH Q10 Pharmaceutical Quality System clearly states that a pharmaceutical company should have a system for implementing corrective actions and preventive actions (CAPA), resulting from the investigation of complaints, product rejections, nonconformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring. LIMS is a key contributor to collect this kind of information in a structured approach. Modern Quality by Design (QbD) initiatives are changing the focus from Corrective (action to eliminate the cause of a detected nonconformity) to a proactive approach (action to eliminate the cause of a potential nonconformity). Simatic IT Unilab offers interactive
dashboard functionality, allowing plant and lab managers to drill down to fully understand the details and create reports to investigate the root cause. LabWare provides a dedicated module for managing the lifecycle of investigations including integration with Trackwise from Sparta Systems. Creating an investigation in LabWare LIMS can simultaneously initiate a Trackwise investigation, in which case
Image of a LIMS dashboard (Courtesy LabWare)
the LabWare investigation record will normally be limited to recording details of the laboratory follow-up, and Trackwise will capture the main detail of the investigation work, including production- related information. SAP supports OOS investigations through integrated defect handling using quality notifications in SAP ERP, which can be generated automatically in case an out-of-spec result is entered in the system. The quality notification type can be configured appropriately to match with the requirements of the relevant GMP/ FDA regulations. PerkinElmer, Thermo
‘thE MoSt
EffIcIEnt EngInEErIng aPProach to
ManufacturIng aPPLIcatIonS IS ModuLar’
Fisher and Starlims have full OOS support and can create reports to match the customer needs.
Peeling away layers The most efficient engineering approach to manufacturing applications is modular; that is, to use a library of standard building blocks to configure applications. Service-Oriented-Architecture (SOA) is an
approach to develop enterprise software applications in such a way that software processes are broken down into granular ‘services’, which are then made available and discoverable on the corporate network. SOA will give business the ability to extend services to new customers (information consumers), streamline business processes (modular and interchangeable components) to help business work more efficiently with partners and suppliers, and unlock information to other systems that need it. MES, ERPs, SDMS, LIMS and ELNs
provide logical building blocks for assembling such a hub. Deploying SOA applications will decrease the potential costs for customising or tailoring solutions among the enterprise. ISA 88 and ISA 95 are de-facto standards used in the manufacturing automation and have proven very beneficial. The ISA-95 standard generically defines the functions of manufacturing and the information exchanged between the production and enterprise levels. Every manufacturing process can be modelled according to the scheme. Operating procedures, business
processes, material and information flows differ, as well as materials, products, and equipment, all of which can be templated using this process. Both Siemens and SAP natively support the ISO 88 and ISA 95 standards, while the dedicated LIMS vendors allow integration with the
➤ 7
L IMS: Enhanc Ed fE aturE S
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