This document discusses Platina QMS, an electronic quality management system from Formpipe Software. It provides a company overview of Formpipe, describing Platina QMS as a fully validated, web-based system that meets FDA and EU compliance requirements. Platina QMS is a centralized platform that tracks documents, processes, audits, deviations and CAPAs. It offers configurable modules, powerful reporting, and integration with Microsoft Office. Customers gain visibility, control, automation and productivity through Platina QMS' scalable and intuitive interface.

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