IBM

iPharma360 combines content, document, record and process management and capture and business intelligent analytics technologies to support all information types in the organization. It also has an integrated platform for capturing, managing and collaborating across the pharmaceutical value chain.

• Complete end-to-end business process management from application to issue
• Handles web-based, paper based and electronic information
• Business rules are managed and updated by business users
• Casefolders organize and manage all content and supporting documentation
• Process rules collaboratively route application cases to where they are required in the process
• Complete audit trail and history of all activities
• Automatic escalation and exception handling of cases
• Metrics and Business Intelligence automatically tracked and available for reporting
• Templates insure faster time to implementation
• No software is required on client machines except for a web browser

Shorten and Streamline New Drug Development Cycles OR Launch Faster:

• iPharma360: Corporate Quality Assurance organizes and manages documents required to administer the information related to the formulation, proper handling, packaging and testing of drugs and ingredients. Documents are revised and reviewed in a controlled fashion and the comprehensive security inherent in the system insures that end users of the documents have access to the latest procedures while those developing those procedures have complete control over the next set of revisions to be published.
• iPharma360: Artwork Management provides a central artwork repository and design tools to increase efficiency and secure quality artwork management. It provides higher scalability in managing and gathering artwork data from multiple stakeholders as well as making the process of approval more prompt.
• iPharma360: Marketing Communication simplifies the information material approval creation and management before introducing or re-launching a pharmaceutical product into the market. Users can manage multiple versions of marketing materials and access a central repository remotely.

Manage Compliance and Reduce Risks:

• iPharma360: CCP allows pharmaceutical companies to enforce the mandated change control process set by the FDA's Current Good Manufacturing Processes. It makes change control more productive and minimizes regulatory risks such as fines and process delays.

Simplify Regulatory Submissions:

• iPharma360: DM is a web-based electronic dossier management that allows pharmaceutical companies to create, revise, approve and manage submissions of new or existing drugs to regulatory agencies.
• The iPharma360: DMF module for Active Pharmaceutical Ingredients (API) manages the information required to submit a Drug Master File to the FDA, EMA or other international regulatory body. It gives companies visibility into the regulatory document management lifecycle from document creation, to submission, to post submission inquiries and corrections.
• iPharma360: Agency Inquiry Management supports Outlook integration MS Office 2003 SP2 Office Express. The integration provides custom add-in buttons to "Save to Capture" and "Save to IBM ECM" to integrate e-mail messages into the document and business process management system.

Business Benefits:

• iPharma360: CCP allows pharmaceutical companies to enforce the mandated change control process set by the FDA's Current Good Manufacturing Processes. It makes change control more productive and minimizes regulatory risks such as fines and process delays.

Simplify Regulatory Submissions:

• Measurable Return on Investment
• Faster Product Approval from Regulatory Agencies
• Provide Business Intelligence in key performance areas
• Provide automatic, verifiable and consistent decisions
• Provide a better customer experience
• Provide complete audit trail of documents and actions related to an application
• Control access to information in compliance with HIPAA and all other security regulations
• Provide greater visibility to management on the status of applications both pending and issued
• Streamline processing to allow a higher volume of work to be done by the same number of people
• Enable knowledge workers to update the rules and processes without reprogramming