Product Life Cycle System is a system that enables the collection, analysis, storage and sharing of data related to products, manufactuing processes and components throughout the product lifecycle according to Annex 15.
Product Life Cycle System enables:
- Merging data describing activities at all stages of the product life cycle into a single stream of information about product and process.
- Integration with the quality system.
- Continuous improvement of process performance and product quality by identification and control of sources of variation and causes of defective product.
- Standarization of technological process development based on the QbD methodology.
- Evaluation of criticality of quality attributes, process parameters and risk of occurrence of OOS results for product attributes based on knowledge gained and experimental data.
- Ongoing real-time verification of the process with identification of atypical trends and OOT/OOS results.
- Visualization of the 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 (OOS/OOT, Cpk) and technological indicators (production waste, time of technological operations).
- Integrated portal that enables a holistic view of process performance and product quality throughout the product lifecycle from development to commercial manufacturing.
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Process development, validation, verification
Process development, validation, verification. Module 1 Criticality and risk assessment
Process development, validation, verification. Module 2: Design of experiments
Process development, validation, verification. Module 3: Process validation
Process development, validation, verification. Module 4: Ongoing process verification