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Integrity Solutions Europe
T.
+44 (0) 20 8793 9531
F.
+44 (0) 20 8793 9531
E.
contact@integrity-solutions.co.uk
Integrity Solutions Japan
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+81-3-6420-0775
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+81-3-6420-0162
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contact@integrity-solutions.co.jp
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Testimonials

"Responsive, reliable and knowledgeable.  Integrity Solutions have been a great partner in projects we have undertaken together at Allergan"
Ka-Wai Chan, R&D Information Systems, EU and AP

Case Studies

BACKGROUND

  • Global pharmaceutical operation
  • Disparate quality systems
  • Limited quality culture across organisation
    Complex IT quality governance structure

OBJECTIVES

  • Develop understanding of industry practice and regulatory expectations (e.g. GAMP®, ITIL®, PIC/S, SOX)
  • Establish quality policies, standards and processes in response to business & IT strategy, external laws and regulation
  • Establish simplified IT quality governance structure
  • Effective and efficient processes that operate globally

ROLE

  • Management workshops to raise awareness of industry practice and regulatory expectation.  Technical training of IT personnel
  • Gap analysis of existing QMS’ to leverage current best practice
  • Workshops defining new governance structure and IT processes.
  • Manage SME process development teams.
  • Gap analysis and remediation of quality records against implemented policies, standards and processes
  • Manage Service Desk, EDMS, Training Management systems

OUTCOME

  • Clarity of IT quality and business quality roles and relationships
  • Common IT standards and processes across IT organisation
  • Qualified IT infrastructure
  • Implemented and validated support systems
  • IT knowledge of industry standards and regulations increased

CHALLENGES

  • Promoting operational effectiveness over regulatory compliance
  • Integrated processes addressing GxP, SOX, Data Privacy &  Security
  • Different perceptions of regulatory expectations across regions and organisations
  • Gaining commitment of resources to develop processes

BENEFITS

  • Effective “global” IT processes through use of automated systems (e.g. Service Desk, EDMS, Training Management)
  • Shorter infrastructure project timescales and fewer service calls
  • Greater resource mobility
  • Significantly improved outcome of compliance audits