The Integrated Knowledge Management Systems facilitate integration of data from different areas of the company’s operation and efficient management of collected information throughout the company. With the use of data and result visualisation tools and statistical analyses, raw data is transformed into practical information which can be used to improve the company’s efficiency.
Based on current requirements and many years of experience in the implementation of analytical systems for pharmaceutical companies, StatSoft Polska experts design an Integrated Analytical Platform, which enables the collection, analysis, storage and sharing of data related to products, manufacturing processes and components at different stages of the product life cycle according to Annex 15 covering process design, process validation and on-going process verification.
StatSoft Polska system is dedicated both for research and development departments, which are interested in implementing the QbD approach to development works, for quality assurance departments that want to monitor the process in real time with detection of atypical trends, as well as for technological departments dealing with increasing the effectiveness of manufacturing processes of medicinal products.
The integrated analytical platform will enable the following:
- Linking activities at different stages of the life cycle into a single stream of product and process knowledge and integration with the quality system
- Standardization of technological process development based on the QbD methodology, which allows for optimal selection of the type of experiment and evaluation of experimental data.
- Definition of the optimal range of process/formulation parameters by assessing the influence of the variability of the parameters of materials, process and their interactions on the product parameters.
- Evaluation of criticality of process parameters and risk of occurrence of OOS results for critical attributes of the product based on accumulated knowledge and experimental data.
- A statistical assessment of validation batches with an assessment of the likelihood of the OOS result occurring during the routine manufacture of the medicinal product
- Ongoing real-time verification of the process with identification of atypical trends and OOT/OOS results
- Reduction of production cycle time and production waste through optimization of process parameters on the basis of data collected from the current process
- Visualization of the process and availability of process monitoring results in real time for persons involved in releasing the product on the market (e.g. Qualified Person)
- Generation of automatic notifications and OOT/OOS alerts for persons involved in the release of the product on the market
- Monitoring of quality indicators (number of OOS/OOT, Cpk) and technological indicators (production waste, time of technological operations)
- Generation of standard process evaluation reports at different stages of the product life cycle
- Collection of data from scattered sources of information: production equipment, repositories such as LIMS, Excel, SAP or Track-Wise in one central database
- Integrity and security of data storage through the access and authorization system together with tracking changes introduced in the IT system
- Validation of the system in accordance with the requirements of Annex 11 and compliance with GAMP 5.0 standards.