Platina – Quality Information Management

FormPipe Platina is an integrated quality information management system for Life Science companies operating within FDA and EMEA regulatory environments. FormPipe Platina provides: SOP management, electronic signatures, deviation management, CAPA processes, customer complaints, change requests, validation and regulatory application records, GMP policy and compliance training, electronic lab notebooks, and document repository.

FormPipe Platina is a web-based software that enables easy creation, management, tracking and control of all quality-related information, documents, records, tasks and processes. Using FormPipe Platina you can ensure regulatory compliance across your entire operations from research and development to drug manufacturing and distribution.

FormPipe Platina is able to achieve this without the complexity associated with other comprehensive information management systems. The simple platform concept together with intuitive tools and a user-friendly interface make solutions easier and quicker to implement than alternative systems. You also gain greater flexibility to meet your specific requirements and to expand the system as your company grows or your needs change.

Electronis records and deviation management

The integrated electronic approach allows you to connect documents, records and processes in a way that is impossible with manual paper-based systems. The system is easy-to-use and requires little user training, which means it starts making a positive impact from day one.

Compliance – Supports validation and use in full accordance with current US and EU GMP standards for pharmaceutical manufacturing as set forth by regulatory bodies. 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.

Efficiency – Electronic records and documents combine with automated processes to create extremely efficient workflows. Connecting people, data and routines reduces process cycle times and shortens time to market, as well as saving valuable time for the individuals involved.

Control – Provides structured management of quality-related documentation and processes with full traceability. Includes powerful and user-friendly tools for creating and amending processes, as well as managing and retrieving documents and records. Also includes routine and ad hoc reporting tools for measuring processes and supporting continual improvement.

Quality assurance – Ensures confidence in your quality management system by significantly reducing the risk of anything falling through the gaps. Efficiency gains also free up time that can be spent on enhancing internal quality processes.

Flexibility – Provides a scalable system able to grow with your needs. You decide what functionality you require and which applications should be installed over what timeframe. Applications can be configured to meet your specific needs, but as they are based on standard functionality they are always fully upgradeable.

Cost effective – Efficiency improvements, consolidation of IT costs and saved time for personnel generate an improvement on your bottom line. It is not uncommon for companies to see a return on investment in as little as one or two years.

To find out more, please see our website.