Regulatory Compliance Services & Solutions | HCL Technologies

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Overview

As the EMA has provided a phased plan for defining and implementing standards, Life Sciences CIOs and business leaders need a flexible system that can evolve to meet the standards as they get released. Our IDMP-360TM platform provides a flexible and configurable platform approach to meet the evolving IDMP standards, developed on the industry-leading Appian platform.

While the Appian platform enables configurable business processes, comprehensive dashboards to manage compliance risk and business decision support on the front end, we also provide a configurable data platform based on an industry leading MDM solution to automate data extraction from a variety of structured, unstructured data sources, enforce IDMP compliant control vocabulary and submission to the regulatory authorities. The solution implementation approach recognizes, that, the impact of IDMP standards will not be limited to compliance function. The solution provides tools to manage People, Process, and System changes throughout the implementation process.

The solution includes out of the box 360 degree view of records that help clients drive better Return On Investment (ROI). These views are designed to enable improved Pharmacovigilance, enable ePrescription, control falsified medicines, reduce shortages, minimize costs & time for Batch Recalls, and support audits & inspections.

The platform also has an inbuilt powerful workflow engine with capabilities for serial flows, parallel flows, rule-based flows, message-based flows, timer-based flows, multi-instanced activities, sub-processes, iterative activities, and decision gateways. This enables the Regulatory function to manage various types of situations and approval cycles in an easy-to-use fashion.

Another powerful feature of this platform is a highly intuitive and modern UI that runs on modern browsers and dedicated tablet applications, with no-difference in functionality. This imparts flexibility to the Regulatory team to handle all their activities intuitively on the platform using the rich-user interface as well as for those on the go. While designing the UI, the day-in-the life of various Regulatory user groups have been used to define persona based experiences, so that they can manage their activities on the platform with ease.

Key features of the Our IDMP-360TM Platform include:

  • Fully compliant cloud-based custom configurability
  • Enable Data, Processes, People, and Change Management for IDMP
  • Flexibility for management of evolving IDMP standards through robust Master Data Management
  • Versatile Data Integration, Aggregation, and Data Curation
  • Get 360-degree visibility of data and records across all IDMP areas
  • Provide meaningful insights for decision makers using these records and existing Enterprise Systems
  • Complete data lineage to address compliance and traceability needs
  • Lower compliance management efforts through intuitively structured and workflow managed processes
  • Work anywhere – browsers, tablets, mobile app with rich functional UI that provides MDM capabilities even to business users
  • Role based user experience for various Regulatory user groups
  • Extend the benefits to other stakeholders from Research to Supply Chain, through extensible UI
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Pharma & BioTech