EQMS Enterprise Quality Management System

Platina QMS by Formpipe – Next Generation QMS
Platina QMS is a fully integrated Enterprise Quality Management Software (EQMS) that puts you in complete control. Platina QMS can ensure regulatory compliance across the entire enterprise – from R&D to drug manufacturing and distribution. It provides full support for meeting regulatory compliance with FDA Title 21 CFR Part 11 and EU Annex 11 requirements, involving all the relevant aspects including data security and integrity, traceability and audit, along with electronic signatures. Using Platina QMS, it is possible to automate routine operations while simultaneously improving efficiency and ensuring quality at every level.

The life sciences industry is one of the most regulated of all industries, with rules and laws covering the full spectrum of processes from product development and clinical trial to manufacturing and distribution. But regulatory demands are only one driver of the constant need to ensure and raise quality. There are also constant needs to adapt to technical change, lower costs in the face of global competition and surpass ever–higher customer expectations.

Yet at a time when ensuring effective quality management, maintaining compliance and streamlining processes have never been more vital, many companies are struggling with inefficient paper-based quality management systems (QMS).

Formpipe overcomes these problems with Platina QMS – a robust yet flexible software solution for managing complex process and quality requirements that is also integrated, safe, easy to use, and scalable.

Applications
Whether looking for a system to manage regulatory documents, SOPs, Corrective and Preventative Actions (CAPA), change control, training, etc., Platina QMS provides a comprehensive, user-friendly and ready-to-use software solution that enables easy creation, management, and tracking of all quality-related documents, records, events and processes throughout the entire enterprise. The flexible and web-based system comes with pre-defined and ready-to-use modules that include:

• Document Management: SOP-management, specifications, external documents, reports etc.
• Case Management: Deviation management, CAPA management, Change Control management, etc.
• Training: SOP-training, Introduction and Qualification programs training, training events etc.

Crucially, these ready-to-use and configurable modules are all easily managed and overviewed within the same system. This means elaborate processes such as annual reports and periodic reviews can be managed holistically and far more easily.

Quality Assurance
Platina QMS is developed according to Formpipe’s rigorous QMS standards to support full validation of the software in accordance with current US and EU GMP standards for pharmaceutical and life sciences manufacturing. It also supports the validated use of electronic records and electronic signatures in compliance with FDA Title 21 CFR Part 11 and EU Annex 11. Platina QMS provides a full audit trail of all objects in the system and electronic signatures that can be linked to specific tasks, documents or events.

Architecture
Platina QMS is an advanced vertical application developed on the established Platina platform that is already being used by thousands of daily users, including companies within the life sciences industry as well as Swedish government and healthcare agencies. The platform is based on the powerful and well-proven Microsoft technologies stack, including ASP.Net, Microsoft IIS and Microsoft SQL Server.

The combination of document control management, case and training management with ready-to-use reports and a powerful process engine for automated workflows makes Platina QMS an outstanding choice for compliant, safe and efficient quality management.

For more information on Platina QMS or to discuss how it could fit your business needs, please contact Formpipe directly.