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 the drug product after approval, many regulatory agencies such as the United States Food and Drug Administration (FDA) also require that the drug product be tested for its identity, strength, quality, purity and stability before it can be released for use. For this reason, pharmaceutical validation and process controls are important in spite of the problems that may been countered. IPQC are checks that are carried out before the manufacturing process is completed.
ShopFloorIPQC will automate the transactions between IPQC instruments and ShopFloorIPQC software. ShopFloorIPQC Software shall be used to manage the in-process sampling using IPQC instruments. It will read the test results from the instrument and transfer the data to application software on a real-time basis. ShopFloorIPQC software supports the functionality of In-Process Quality testing operations according to the needs of the industries. It contains instrument details, meets 21 CFR Part 11 compliances, reports, integration to 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 trail, and advanced user management to LDAP integration, batch comparison, and LIMS import / export functions – the IQMS framework is designed for implementation of an efficient, fully 21 CFR Part 11 compliant system.
Modules as Needed
- User Management
- LDAP Integration
- Instrument configuration
- Receipe Management
- Data Trending
- MES Integration
- LIMS Integration
- LIMS Integration
- Analytics and Prediction
