The life science industry is one of the most regulated, covering the full cycle from product development and clinical trial to manufacturing and distribution. Besides the regulatory demands, the complex nature of this industry requires adaption to constant changes. Focus on customer needs and internal efficiency has become essential to compete effectively.
Today many Life Science companies are drowning in inefficient paper-based systems while struggling to maintain compliance and streamline development and production processes. FormPipe Software provide a robust yet flexible software solution for managing complex process- and quality requirements in an electronic, safe, easy-to-use, and scalable manner.
FormPipe Life Science QMS and Regulatory Document Management
FormPipe Life Science is a fully integrated Enterprise Quality Management Software (EQMS) that puts you in complete control. Using FormPipe Life Science you can ensure regulatory compliance across your entire enterprise - from research and development 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 eg. data security, data integrity, traceability/audit, and electronic signatures. Using the flexible software solution it is possible to automate routine operations and improve efficiency on every level.
QUALITY Management- MADE EASY
Whether looking for a system to manage regulatory documents, SOPs, Corrective and Preventative Actions (CAPA), change control, training etc., FormPipe Life Science provides a comprehensive, user-friendly and ready-to-use software solution that facilitates 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 for e.g:
-
Document Management (e.g. SOP-management, specifications, external documents, reports etc.)
-
Case Management (e.g. Deviation management, CAPA management, Change Control management etc.)
-
Training (e.g. SOP-training, Introduction and Qualification programs training, training events etc.)
The above ready-to-use as well as configurable modules are all easily managed and overviewed in the same system. Compared to using manual paper-based systems or stand-alone solutions, you gain full traceability, searchability, and not least a more efficient way of working. Additionally, elaborate processes such as annual reports and periodic reviews are a lot easier managed through utilization of the holistic system when compiling the information necessary.
ASSURANCE OF QUALITY
FormPipe Life Science is developed according to Formpipe Software’s strict QMS to support full validation of the software in accordance with current US and EU GMP standards for pharmaceutical and Life Science 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. Naturally, FormPipe Life Science has full audit trail of all objects in the system and electronic signatures that can be linked to specific tasks, documents or events.
well proven platform for EFficient quality management´
|
|
|
FormPipe Life Science is an advanced vertical application developed on the established FormPipe Platina platform. FormPipe Platina is being used by thousands of daily users, among them companies within the Life Science industry as well as Swedish healthcare and governmental agencies. The platform is based on the powerful and well proven Microsoft technologies stack, including ASP.Net, Microsoft IIS and Microsoft SQL Server. It comes with ready-to-use modules for document, case,- and records management, as well as a business processes engine and advanced reporting tools. Using FormPipe Platina as platform, FormPipe Life Science implements types, objects and workflows specific for the life science industry.
|
Users of the FormPipe Platina platform appreciate the benefits of control and traceability in combination with a scalable and cost-efficient business solution. Combining document control management, case and training management with ready-to-use reports and a powerful process engine for automated workflows make FormPipe Life Science an outstanding competitive choice for compliant, safe and efficient quality management.
Read more about:
-
Solution for long-term digital data preservation,
click here
-
FormPipe Platina as platform for FormPipe Life Science EQMS solution,
click here