Fusion QbD – Quality by Design software for Scientists and Engineers
Fusion QbD is a quality by design platform that works with your Chromatography Data System (CDS) to structure experiments and transform raw data into knowledge. Design of Experiment (DOE) tools, CDS integration, GMP compliance, and built-in intelligence, make Fusion QbD the premier QbD software choice for all your development activities.
Modules exist for HPLC method development, analytical method validation, process (or product) development, and inhaler testing. These tasks traditionally involve the use of multiple software packages, neither integrated with the next. This results in large quantities of data being manually transcribed from one software product to the other and represents the largest single source of quality issues, despite the large amount of time dedicated to transcription checking.
In addition, the necessary calculations and reporting are often performed in non 21 CFR Part 11 compliant software such as generic statistical packages, Excel, or CITDAS. This raises concerns over data integrity and traceability.
Fusion QbD does away with these issues with all activities being performed in a compliant environment. Fusion QbD saves time and money while improving compliance and quality.
LC Method Development
Develop a robust Method Operable Design Region (MODR) for your LC Methods in a fraction of the time using Analytical Quality by Design (AQbD) methodologies, 100% aligned with ICH Q14 and USP<1220> guidelines. Maximise HPLC utilization and data integrity with validated data exchange between Waters Empower and Thermo Chromeleon, including support for column and solvent switching valves, on-line mobile phase preparation, and utilisation of peak property, Diode Array, and or Mass Spectroscopy data for automated peak tracking.
Method Validation
Save time and money by automating your analytical method validation planning, execution, data analysis and report generation. Early and Final phase routines exist producing submittal quality reports.
Process Development
Idealy suited to formulation development, tableting studies, spray drying optimisation, Orally Inhaled and Nasel Drug Product development, dissolution method development, mass spectroscopy method development, or mixing/blending optimisation. Whatever the process or product, plan, organise, analyse, optimise and report your experimental data in one 21CFRpart11 compliant application.
Fusion Inhaler Testing
A Chromatography Data System (CDS) integrated, 21 CFR Part11 compliant product for cascade impaction and delivered dose testing of Orally Inhaled and Nasal Drug Products (OINDPs). Huge time savings and quality improvements have been demonstrated by the adoption of Fusion Inhaler Testing.
