MDM-AGIDMP SOLUTION FOR IDMP COMPLIANCE - · PDF fileIDMP Eg. SAP MDM, Informatica MDM •...
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IDMP compliance guidelines are currently in a draft stage and will be mandated by EMA within Q1 2017. It might be followed by US FDA, Japan PMDA and other global regulatory bodies. As per the mandate, global pharmaceutical companies operating in Europe need to comply effective by Q1-2017, this would not only standardize processes for mutual exchange of the data but even optimises the processes across global regulators, biopharmaceutical companies and their respective business and IT managing stake holders. This in turn saves cost and time to two fold that would be huge savings to Biopharmaceutical, Medical Device companies and to their respective stakeholders. Differentiators • Expertise in IDMP business impact • First of its kind Centralized Product Dictionary based on the Master Data Management (MDM) approach • Experience across Pharma applications impacted by IDMP • Data model complies with entire ISO IDMP Data Model Out of the Box (OOTB) • Strategic Solution with incremental deployment • Program and Change Management Capability Business Challenges • Complex interdependencies across regulators, Biopharmaceutical companies, stake holders managing their business and IT systems across value chain of processes safety, regulatory and clinical. • Different compliance requirements SPL PLR4, ICH E2B R3, e-CTD across regulators US-FDA, Europe-EMA, Japan-PMDA across processes safety regulatory and clinical that are dynamic in nature. Our Solution The IDMP solution is on par with current draft guidance of IDMP from EMA regulator Our solution for IDMP comprises of two pieces, MDM and agIDMP. MDM piece of the solution pulls data from discrete data sources regulatory, safety, clinical, manufacturing and agIDMP solution piece does regulatory interfacing with global regulatory bodies Europe-EMA, US-FDA, Japan-PMDA. Japan-PMDA across processes safety regulatory and clinical that are dynamic in nature. Features • Master Data management piece of IDMP solution consolidates discrete data sources coming from various source systems like regulatory, safety, clinical and other ERP systems. • Technology agnostic MDM solution for IDMP Eg. SAP MDM, Informatica MDM • Medicinal Product IDs, Pharmaceutical Product IDs are auto-populated with our agIDMP piece of IDMP solution interfacing with regulatory bodies (EMA - Europe, FDA - US, PMDA - Japan) • Enhancement of Regulatory information management system on par to IDMP compliance Benefits • Reduce Cost by two fold on current application spend related to IDMP domains • Reduce Risk and eliminate Non- compliance costs through holistic solution and comprehensive implementation model • Accelerate and Comply with IDMP Timelines at optimal cost • Effectively manage organizational change and adoption MDM-AGIDMP SOLUTION FOR IDMP COMPLIANCE
Transcript of MDM-AGIDMP SOLUTION FOR IDMP COMPLIANCE - · PDF fileIDMP Eg. SAP MDM, Informatica MDM •...
IDMP compliance guidelines are currently in a draft stage and will be mandated by EMA within Q1 2017. It might be followed by US FDA, Japan PMDA and other global regulatory bodies. As per the mandate, global pharmaceutical companies operating in Europe need to comply effective by Q1-2017, this would not only standardize processes for mutual exchange of the data but even optimises the processes across global regulators, biopharmaceutical companies and their respective business and IT managing stake holders. This in turn saves cost and time to two fold that would be huge savings to Biopharmaceutical, Medical Device companies and to their respective stakeholders.
Differentiators • Expertise in IDMP business impact
• First of its kind Centralized Product Dictionary based on the Master Data Management (MDM) approach
• Experience across Pharma applications impacted by IDMP
• Data model complies with entire ISO IDMP Data Model Out of the Box (OOTB)
• Strategic Solution with incremental deployment
• Program and Change Management Capability
Business Challenges• Complex interdependencies across
regulators, Biopharmaceutical companies, stake holders managing their business and IT systems across value chain of processes safety, regulatory and clinical.
• Different compliance requirements SPL PLR4, ICH E2B R3, e-CTD across regulators US-FDA, Europe-EMA, Japan-PMDA across processes safety regulatory and clinical that are dynamic in nature.
Our SolutionThe IDMP solution is on par with currentdraft guidance of IDMP from EMA regulatorOur solution for IDMP comprises of twopieces, MDM and agIDMP. MDM piece ofthe solution pulls data from discrete datasources regulatory, safety, clinical,manufacturing and agIDMP solution piecedoes regulatory interfacing with globalregulatory bodies Europe-EMA, US-FDA,Japan-PMDA. Japan-PMDA acrossprocesses safety regulatory and clinical thatare dynamic in nature.
Features• Master Data management piece of
IDMP solution consolidates discrete data sources coming from various source systems like regulatory, safety, clinical and other ERP systems.
• Technology agnostic MDM solution for IDMP Eg. SAP MDM, Informatica MDM
• Medicinal Product IDs, Pharmaceutical Product IDs are auto-populated with our agIDMP piece of IDMP solution interfacing with regulatory bodies (EMA - Europe, FDA - US, PMDA - Japan)
• Enhancement of Regulatory information management system on par to IDMP compliance
Benefits• Reduce Cost by two fold on current
application spend related to IDMP domains
• Reduce Risk and eliminate Non-compliance costs through holistic solution and comprehensive implementation model
• Accelerate and Comply with IDMP Timelines at optimal cost
• Effectively manage organizational change and adoption
MDM-AGIDMP SOLUTION FOR IDMP COMPLIANCE
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