Electronic Quality Management System for companies operating in GxP environment.

1. Platina QMS
Jacob Mathew
Business Development Director
Electronic Quality Management System

2. Agenda
• Company overview
• Platina QMS
• Common questions raised by auditors/inspectors
• Customers
• Our certified partners in UK

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. • 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. • 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. • 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. Yes, they are all in Platina QMS!

8. Documents
SOPs
Deviations
Change
control
Training
Complaints
CAPAs
A single integrated enterprise QMS solution

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. • 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. 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. Some of our customers

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. Thank you!
www.formpipe.com/lifescience
Jacob Mathew - Business Development Director
jacob.mathew@formpipe.com
0786 68 42 978