Process ANalysis DAtabase (PANDA)
PANDA for the pharmaceutical company
- Process Validation
- Continued Process Verification (in accordance with FDA Guidance)
- Process Performance Qualification (PPQ)
- Quality Reporting / Annual Product Review (APR)
- Global Routine & Stability Trending
- Global Analysis Data Entry
- Full Batch Traceability
- Data Management
- Data Mining
- Data Archiving
PANDA (Process ANalysis DAtabase) is a system for integration and processing of data from different data acquisition systems (such as LIMS, ERP, PDA and machine process systems) which are used in pharmaceutical companies in research, development, implementation up to production and clearance. Data are linked, structured, aggregated and mapped using PANDA. Data remain protected via access and mandator administration.
Advantages you gain by PANDA
- No further costs per product or product group
- Comprehensive solution for all customer products
- Products are configured by the customer in the PANDA Client
- Integration of all known LIMS systems (SAP/QM, QDIS/QM, Labware etc.)
- Integrative evaluation of product batches via several source systems
- Full configurability for analyses and reports
- Configurable web interface for acquisition of analytical batch data (Generic Communicator)
- Additional interface for Excel sheets containing analytical batch data
- Mapping and research of the batch tree in the web interface (batch traceability)
- PANDA is validated for the pharmaceutical industry according to GAMP 5
One strength of the PANDA system is its universal expandability. It is possible to integrate and cross-link data of further source systems. All data are stored and processed in the ORACLE database. PANDAs open architecture enables standard evaluations and analyses and permits individual research directly on the database level (e.g. for process improvement teams). Data are provided to the mandators in separate data base schemes.
PANDA Client / graphical user interface
Via the mature graphical and multi-lingual user interface, the user is optimally supported during data linkage corresponding to the business know-how. Thus, the user focuses on the essential steps to contribute the necessary, irreplaceable human intelligence. The user is spared tedious, repetitive work.
The Critical Quality Attributes (CQA) and the Critical Process Parameters (CPP) can be easily defined by the user as well as the trends and the statistical analysis.
Statistical Analysis and Reporting
PANDA comes with the direct, mature control interface for the STATISTICA 12 Enterprise Server. This server can be used to store standard analyses, Routine trending or reports and make them accessible to users via STATISTICA.
Among others, the following configurable analyses are available:
- Control charts
- Process capability histograms
- Table of values
- Chi-squared distribution tests
- Run tests
- Line and scatter plots
- X/Y plots
- Variability plots