EN
PL
StatSoft PLCS Product Life Cycle System is a database system that enables the collection, storage, analysis, and sharing of information at various stages of the product life cycle, starting with research and development, through the validation of the designed process, and verification of the ongoing process during routine production.
The system consists of four modules:
(1) Criticality and Risk Assessment
(2) Design of Experiments
(3) Process Validation
(4) Ongoing Process Verification
The modules can operate as an integrated system or independently of each other depending on the user needs. The software is validated in accordance with cGxP requirements.
Module: Criticality and risk assessment
Functionalities:
- Defining quality target product profile QTPP
- (Auto) Selection of critical quality attributes CQA
- (Auto) Selection of critical process parameters CPP/CMA
- (Auto) Identification of risk to quality attributes
- Selection of variables for design of experiments
- Linking QTPP with CQA with CPP/CMA as per QbD
- Visualization of criticality and risk assessment
- Filtering and sorting variables with respect to quality risk
- Focusing R&D efforts on what matters the most
- Real-time collaboration on QbD projects
- Generation of documentation to be submitted to dossier
Module: Design of experiments
Functionalities:
- Defining whole research plan for the product
- (Auto) selection of experiment design
- (Auto) selection of statistical model
- (Auto) calculation of criticality
- (Auto) selection of design space
- (Auto) calculation of quality risk
- (Auto) selection of parameter range
- Screening, characterization, optimisation experiments
- Designing experiments for process and formulation
- Optimisation of operating ranges for process parameters
- Criticality and risk calculated based on experimental data
- Generation of documentation to be submitted to dossier
Module: Process validation
Funkcjonalności
- Defining process validation plan
- Selecting measurement / sampling scheme
- Immediate notification on adverse results after data entry
- Visualization of batch status using quality metrics
- Statistical analyses of process validation results
- Generation of statistical reports in a timely manner
- OOS probability calculation to facilitate decision making process
- Batch equivalency evaluation during technology transfer
- Manual or automatic (option) data entry
Module: Ongoing process verification
Functionalities:
- Defining ongoing process verification plan
- Selecting measurement / sampling scheme
- Notification on adverse events after data entry
- Visualization of process status with quality metrics
- Statistical analyses of process verification results
- Generation of statistical reports in a timely manner
- Manual or automatic (option) data entry
- As an option existing data upload using ETL procedure
- Facilitation of batch release using quality dashboard
