Global Specialty Pharma Company

Corporate Wide IV&V

Case Study

Global Corporate Validation Program

US, UK, South Africa, Japan, Singapore, Australia and New Zealand

Global Specialty Pharmaceutical

Specialty pharmaceutical companies are characterized by their ability to handle specialty drugs or pharmaceutical and are a recent designation of pharmaceuticals that are classified as high-cost, high complexity and/or high touch. Our client is a global specialty pharma company who embarked on a corporate-wide technology automation initiative to replace outdated legacy technologies with more efficient, agile, enterprise cloud-based technologies to support quality, regulatory, corporate administration and finance, and supply chain systems.  A critical focus of this initiative is that many of these technologies required validation.

The business objectives for this initiative were as follows:

  1. Enhance and deliver enterprise technology solutions
  2. Automate and accelerate manual, paper-based validation processes
  3. Embrace cloud technologies
  4. Harmonize enterprise infrastructure

Due to the regulatory impact of the data housed within the ERP system, OnShore was engaged to deliver a qualified validation team to validate the system in accordance with global regulatory guidelines.

Purchase ValidationMaster Enterprise Validation Management system and/or CloudMaster 365 Validation Accelerator

yes
yes

onshore professional services

validationPro-multicolor

Methodology and approach

ValidationPro℠ is a turnkey IV&V service offering designed to deliver a qualified team of validation engineers to perform end-to-end validation services.  Our engagement began with our 5-day Validation Workshop.  The workshop is designed to establish common ground with the client and to review their validation readiness.   We setup and configured the ValidationMaster system as the single source of truth for all validation projects.  All validation test documentation (IQ/OQ/PQ/UAT) were developed and managed by ValidationMaster.

Results

Impacts and outcomes

OnShore Technology Group delivered a team of qualified validation engineers and project managers to manage and provide oversight of the validation effort.  The multifaceted initiative consisted of the integration of multiple technologies subject to validation.  Our team of validation test engineers prepared all validation document deliverables and leveraged DocuSign through the ValidationMaster Portal to electronically route/review and approve all validation documentation.  Test case development and execution was conducted using the ValidationMaster software.  Requirements were created and managed in the system and traced to each respective test script.  The system generated a forward and reverse traceability matrix for the entire effort spanning over 2,000 requirements and 5,700+ test cases (IQ/OQ/PQ/UAT).  The system included over 60+ customizations and 3rd party integrations including serialization, EDI, Label Control, Oracle Service Cloud and many others.  The project resulted in a turnkey fully validated ERP system.  As a result of the validation effort, a reusable test script library was developed to facilitate future regression testing.  All documentation was centralized for regulatory review.

Conclusions

5,700 + reusable validation test scripts

90% improvement in document cycle times through electronic signatures

Comprehensive version control for all software applications

85% increase in validation test script development efficiency

Validated all 3rd party integrations and customizations

System is being used by over 500 global users