PharmaLEAN solution is designed for Pharmaceutical Research and Development companies to handle all need and challenges in most efficient, effective & accurate way faced by this industry. PharmaLEAN offers a comprehensive set of research data for easy analysis and interpretation of the massive datasets. The flexibility of PharmaLEAN allows you to accommodate current industry needs, as well as adapt to government compliances that are rapidly emerging in the Pharmaceutical Industry.
Quality control is an integral part of PharmaLEAN and there is full support for compliance with regulatory authorities such as Food and Drug Association (FDA), Central Drugs Control Organization(CDSCO). The analysis based on methods and for methods are part of PharmaLEAN is adhere to regulatory authority controls like US Pharmacopeia (USP), Indian Pharmacopoeia Commission (IPC) or European Pharmacopeia (EU). PharmaLEAN solution provides functionality supports complete formula and recipe management. Functionality provides complete visibility to specific ingredients, intermediates, and formulas which are used in the production of multiple products. Through the integration of formulas and associated processing instructions and notes, process manufacturers can create recipes which are used during batch process production. PharmaLEAN supports Good Manufacturing Practices (GMP) through audit controls of transactions, electronic signatures, and version control with engineering change management of formulas and bills of materials. PharmaLEAN is complete package which enables a centralized trial management database for all investigators with adoption of compliances prescribed by Clinical Trials Registry- India (CTRI). PharmaLEAN is integrated Drug Development Life Cycle Management which traverse through discovery Phase to Manufacturing Phase. Easy to manage New Drug as well as Generic Drug cycle.
PharmaLEAN helps you to manage various programs/projects from start to end of drug development life-cycle. It helps you to manage project WBS/Task/Deliverables using stage gate process. Project WBS is well integrated with deliverables, associated drug elements like Material, API. It also builds cross functional consensus, where discussion and review of alternatives are conducted effectively and all business aspects have been taken into consideration. It provides complete visibility of a project and provides real-time access to project pipelines and data for rapid analysis and decision making.
Formulation Development helps Pharmaceutical companies to add formulations quickly with rapid ingredient selection and access to regulatory compliance tools during development. Formulation integrity is maintained and includes version history. Access to formulations can be managed with security options. User can define formulation by percentage or weight.
Especially for generic drug purpose we have BE/BA study module in PharmaLEAN. This modules helps you to plan, create, conduct and report preparation of BE study. Easy to compare results in generic drug and reference drug as per Schedule Y. Protocol development and CRO review are having well defined workflow.
PharmaLEAN solution includes the ability to quickly create, archive, trace, search and audit all documentation related to the manufacturing and service of a drug. This includes the product specification, protocols, Design of Experiments, risks assessments, lab test reports and phase reviews.
Quality by Design
Quality has been given an importance by all regulatory bodies for pharmaceutical products. Quality means customer satisfaction in terms of service, product, and process. Many of these quality related activities reflect need for companies to excel in global competition. All this can achieve by implementing PHARMALEAN as PHARMALEAN compliant with ICH Q8, Q9 and Q10.
Laboratory Information Management System(LIMS)
LIMS is powerful, fully integrated configuration tools are provided to adapt the software to end-user requirements without compromising support or future upgrades. LIMS lets you manage the sample lifecycle, optimize laboratory execution, perform data retrieval, interface instruments and systems, and enable security and auditing.
Collaboration with CMO & CRO
Successful drug development and technology transfer between a CMO and the sponsor company requires a multifaceted collaborative approach. The project required collaboration in development, manufacturing, and technology transfer; resource allocation of scientific and manufacturing staff; project management; and the resolution of related technical issues. All these are fulfilled with only one solution PharmaLEAN. On the basis of contract between CRO and Sponsor PharmaLEAN can restrict access of information to CRO or CMO.
It records time spent on activities/tasks/projects. After analysis it generates some reports of actual v/s estimated hour/cost for Project/Employee
Artwork and labeling Management
Artwork and labelling development collaboration is managed in system as a workflow. It reduces development time and improves accuracy.