PLATINA ECM DEVELOPMENT
Back in 2008, Formpipe’s ambitious product expansion plans brought the company to a point where its development capacity had to be drastically increased. Thus, they started seeking out a long-term nearshore supplier.
We started working on Platina with product technical review and competitive analysis providing a list of recommendations for improving the information system. Gradually the team has taken over the full-cycle development of the Enterprise Content Management product and now delivers a new major version of the product and a new service pack every year.
- Functionality for documents and cases handling according to the predefined processes
- Tools for collaborative work, creation, approval, and distribution of documents in electronic files format
- Administrator toolkit for design, adjustment, and launch of the document- and case-related processes
- Detailed logging of all user actions for further audit trails & analysis
- Compliant to SOX, ISO, GDPR, WCAG, patient security laws, FDA CFR 21 PART 11 (electronic records and signatures validation), and principles of access to public information
PLATINA QMS CONSULTING
At the beginning of 2011, Formpipe decided to bring Platina to the pharmaceutical market. However, this required company’s Quality Management System to be compliant with GAMP and FDA regulations.
Sigma Software QMS experts joined Formpipe’s team to adapt existing QMS and ensure regulatory compliance across the whole organization. The system has successfully passed three rounds of audit from a large pharmaceutical company – the first customer to Formpipe in life science. Sigma Quality Managers continued Formpipe QMS maintenance and supported external audits from Healthcare operators till the end of 2015.
- Reviewed, evaluated, and documented existing processes
- Introduced additional procedures and instructions to safeguard the QMS compliance to GAMP5, FDA Title 21 CFR Part 11, EU Annex 11 requirements
- Performed trainings for Formpipe QMS personnel
- The QMS provides full procedures and documents (templates, forms, checklists, etc.) coverage for the following areas: Development, Product Maintenance Processes, Project Management and Steering, Supply, Configuration and Infrastructure Management, Human Resource Management, Document Control and Quality Assurance
PLATINA LIFE SCIENCE
Like most of the regulated industries, the Healthcare market is often seen as a separate universe with its own standards, processes, and rules. With this in mind, we helped Formipe turn Platina into a custom ECM solution tailored to the healthcare companies’ needs.
This solution became Platina Life Science – an enterprise-level platform for information governance in pharmaceutical and healthcare companies which is further developed and supported by a separate team at Sigma Software.
- The platform enables document, process, and training record management
- Configurable dashboard and reporting suite based on quality-driven metrics
- Pre-configured workflows and tools for ongoing adaptation and enhancement of the system
- Multi-browser support and intuitive UI
- Available on-premise, as a cloud enterprise content management solution, and within a BYOD environment
- Supports up to 30K daily users and 40M documents
- Notification and tasks access via mobile devices