Platina QMS

Jacob Mathew

Business Development Director

Electronic Quality Management System

Agenda

• Company overview

• Platina QMS

• Common questions raised by auditors/inspectors

• Customers

• Our certified partners in UK

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

• 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

• 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

• 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...

Yes, they are all in Platina QMS!

Documents

SOPs

Deviations

Change control

Training

Complaints

CAPAs

A single integrated enterprise QMS solution

• 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

• 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

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

Some of our customers

‣ 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

Thank you! www.formpipe.com/lifescience

Jacob Mathew - Business Development Director

jacob.mathew@formpipe.com 0786 68 42 978