Diese Präsentation wurde erfolgreich gemeldet.
Wir verwenden Ihre LinkedIn Profilangaben und Informationen zu Ihren Aktivitäten, um Anzeigen zu personalisieren und Ihnen relevantere Inhalte anzuzeigen. Sie können Ihre Anzeigeneinstellungen jederzeit ändern.

Platina Quality Management System by Formpipe

573 Aufrufe

Veröffentlicht am

Electronic Quality Management System for companies operating in GxP environment.

Veröffentlicht in: Technologie
  • Als Erste(r) kommentieren

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

×