The development of a drug product is a lengthy process involving drug discovery, laboratory testing, animal studies, clinical trials, and regulatory registration. To further enhance the effectiveness and safety of drug products after approval, many regulatory agencies, such as the United States Food and Drug Administration (FDA), require drug products to be tested for their identity, strength, quality, purity, and stability before they can be released for use. For this reason, pharmaceutical validation and process controls are important. IPQC involves checks that are carried out before the manufacturing process is completed.
ShopFloorIPQC automates transactions between IPQC instruments and the ShopFloorIPQC software. The ShopFloorIPQC software is used to manage in-process sampling using IPQC instruments. It reads test results from the instruments and transfers the data to the application software in real time. ShopFloorIPQC software supports in-process quality testing operations according to industry requirements. It includes instrument management, compliance with 21 CFR Part 11, reporting capabilities, and integration with MES.
ALL Data in once place
Take full control of your data and manage all your methods, results, and users with ShopFloorIPQC. From electronic signatures, audit trails, and advanced user management to LDAP integration, batch comparison, and LIMS import/export functions, the IQMS framework is designed to implement an efficient, fully 21 CFR Part 11-compliant system
Modules as Needed
- User Management
- LDAP Integration
- Instrument configuration
- RecipeManagement
- Data Trending
- MES Integration
- LIMS Integration
- Analytics and Prediction
