Using Sharepoint as an eQMS or eDMS solution for GMP manufacturers
PharmOut are frequently asked for advice on using SharePoint as a eQMS or eMDS system.
SharePoint is one of the mostly widely installed software platforms within companies around the world – mostly because IT departments in large organisations often got it for free from Microsoft. This means there’s a lot of SharePoint expertise to be found within organisations and many companies offering integration services.
As GMP and GAMP specialists, we were impressed when we discovered that SharePoint can be used as a cost effective electronic Quality Management System (eQMS) or electronic Document Management System (eDMS), suitable for use by regulated companies like pharmaceutical manufacturers.
Our partners, Qiksolve, are SharePoint Integrators specialising in GMP-regulated industries. They have developed the Ibiqs system, a Commercial Off The Shelf (COTS) Microsoft SharePoint solution for pharmaceutical, medical device and raw material suppliers.
Ibiqs is designed to be used on SharePoint that is either installed on a server within your company’s IT infrastructure or on a server in a dedicated data centre. It takes advantage of the Part 11 capabilities of the latest SharePoint version so electronic signatures and audits are built in, making SharePoint 21 CFR Part 11 compliant. Read more about this from Microsoft here.
While Qiksolve provides the services to configure and manage the SharePoint installation and the Ibiqs system, PharmOut provides the requirements specification, qualification and validation services you will need to ensure the system meets regulatory requirements. We work closely as a team to deliver a validated outcome.
Contact PharmOut for more information.