Industry: A Pharmaceutical Company

This case study highlights how Jade Global significantly enhanced the quality and compliance with end-to-end support of one of our pharmaceutical clients. Our client focuses on developing innovative, next-generation drugs. They were facing challenges related to both GxP and non-GxP systems. Leveraging Jade Global's specialized expertise, the company's processes were meticulously streamlined, ensuring strict adherence to regulatory standards.

The solution provided by Jade Global included comprehensive guidance for ensuring the quality of applications, enhanced reporting functionalities, and an improved process for validating computer systems (CSV). A comprehensive analysis of these enhancements is provided in this case study of the pharmaceutical industry.

The consistent outcomes were maintained through the implementation of rigorously validated systems. The improved support and maintenance highlighted the importance of specialized knowledge in the pharmaceutical industry.

About the Client

The client is a pharmaceutical company with three decades of dedication to research and development. They are actively advancing new therapies for brain disorders and cancer. Our client is currently developing eight compounds globally to treat conditions such as epilepsy, ADHD, schizophrenia, bipolar disorder, and various cancers.

Application Maintenance and Support Solution Offered by Jade Global

  • Offered a comprehensive end-to-end Quality applications maintenance and support system.
  • Implemented comprehensive reporting and Dashboard capabilities utilizing graphical views.
  • Validated a detailed project plan and Impact Assessment for each release of Quality applications.
  • Executed CSV documentation to streamline the process as per regulatory guidelines.
  • Streamlined system enhancements and bug fixes, along with new release testing and production promotion.
  • Enhanced applications according to 21CFR Part 11 and GAMP Guidelines.
  • Ensured quality compliance in pharmaceutical industry by maintaining systems as per CSV SOP, SDLC SOP, and GxP guidelines, implementing new enhancements and releases.

Business Requirements

  • Efficient preparation, thorough review, and timely approval of CAPA and Deviations were needed.
  • Comprehensive risk assessment documentation and meticulous approval for Functional and User Requirements were essential.
  • Authoring and timely approval of the Validation Plan, coupled with the development of a comprehensive test strategy and scripts, were necessary.
  • Effective management of both GxP and Non GxP systems to ensure seamless integration and operation was needed.
  • They also wanted both manual and automated execution of IQ/OQ/PQ tests.
  • Strict adherence to Good Documentation Practice and the development of comprehensive IT SOPs were required.
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Jade Global Tested all the below GxP & Non GxP Application

GxP Applications

  • Veeva Vault – Quality Docs / RIMS / QMS
  • Veeva Validation Management
  • ComplianceWire
  • Tracelink
  • Medical Information Cloud (MIC)
  • DocuSign - Part 11 implementation

Non GXP Applications

  • Concur
  • SAP
  • Cardinal 3PL – SAP integration
  • Demand Caster

Business Benefits Achieved:

  • Achieved up to 64.7% increase in Quality & Compliance services and KPIs through strategic enhancements and streamlined processes.
  • Enhanced scalability by up to 55.6%, enabling smooth growth and expanded operational capacities for future demands and challenges.
  • Significantly reduced project timelines by up to 40%, optimizing efficiency and ensuring timely delivery of key milestones.
  • Effectively decreased Non-Conformance handling by 20%, showcasing streamlined processes and improved operational management

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