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Platina Quality Management System by Formpipe

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Electronic Quality Management System for companies operating in GxP environment.

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Platina Quality Management System by Formpipe

  1. 1. Platina QMS Jacob Mathew Business Development Director Electronic Quality Management System
  2. 2. Agenda • Company overview • Platina QMS • Common questions raised by auditors/inspectors • Customers • Our certified partners in UK
  3. 3. Formpipe Software in brief • A leading software company within the ECM and EQMS space • Public company listed at Nasdaq OMX Nordic • 300+ employees • Offices in Stockholm, Uppsala, Copenhagen and Macclesfield, UK and USA • Certified and well trained partners for implementation, validation and support • Strong and proven product portfolio
  4. 4. • Fully validated (GAMP5) system that meets compliance requirements of FDA Title 21 Part 11 and EU Annex 11 • 100% web based solution build on Microsoft .NET and SQL database • Scalable and enterprise-class platform, with one unified workspace, single sign-on and role based security Platina QMS – a modern platform • Tracks non-conformance, deviations and enables triggers for CAPAs, root cause analysis and remediation workflow
  5. 5. • Electronic signature capture • Centralised repository of process documentation, SOPs and training records, with change control capabilities • Powerful, built-in reporting engine with drill-down capability • Complete visibility into the quality system database Platina QMS – a modern platform
  6. 6. • Can I see your quality manual? • …SOPs, work instructions? • …training records? • …change control status? • …asset/equipment status? • …internal audit records? • …deviations, CAPAs? Frequently Asked Audit Questions and so on...
  7. 7. Yes, they are all in Platina QMS!
  8. 8. Documents SOPs Deviations Change control Training Complaints CAPAs A single integrated enterprise QMS solution
  9. 9. • Out of the box pre-configured processes based on industry best practices • Configurable modules that are validation ready for faster implementation • Creation, tracking and management of all documents and processes in a single workspace • Ease of use despite advanced functionality • Strong reporting capabilities for KPIs and trends Unique differentiators
  10. 10. • Fully modular, multi-dimensional approach • Optimised process management, powerful process engine and real-time visibility • Tight integration with Microsoft Office Suite and Outlook • Proven platform used by large enterprise customers in Europe Unique differentiators
  11. 11. Holistic outcomes • Visibility • Better control • Automation through workflow • People productivity, company-wide • Real time insights, enabling better decisions • Integrated and scalable platform that can adapt and grow within a volatile regulated environment • User-friendly, intuitive interface
  12. 12. Some of our customers
  13. 13. ‣ Formpipe’s UK partners for implementation and support of Platina QMS ‣ www.wearesigma.com ‣ www.gxpi.com ‣ Dedicated ITIL service desk for Platina QMS customer support ‣ Significant experience of QMS consultancy, implementation and maintenance in Life Science industry in various global markets ‣ In-house quality management system for project delivery to Pharma and life science companies UK certified partners for Platina QMS
  14. 14. Thank you! www.formpipe.com/lifescience Jacob Mathew - Business Development Director jacob.mathew@formpipe.com 0786 68 42 978