Quality and Document Management
Quality and compliance to regulatory authority guidelines is of principle importance to InSymbiosis. We want to provide peace of mind to our clients that the projects and programs performed with Insymbiosis will withstand regulatory authority scrutiny.
Therefore, InSymbiosis maintains a Quality Management System (QMS). The QMS includes processes for employee training, vendor qualification, management and quality/compliance oversight of GLP/GMP/GCP products and services from third party vendors as well as internal quality auditing. The InSymbiosis QMS ensures compliance to the regulatory standards in the US, Canada and the EU in addition to the ICH guidelines for pharmaceutical development.
The QMS system at InSymbiosis is housed within a formal electronic document management system. This system is used for the management of document life-cycle for QMS documents such as SOPs as well as being used as a repository for all project-related documentation. The document management system is a SharePoint based system that provides a collaborative workspace to facilitate document sharing with clients and vendors. The document management system is fully 21CFR Part 11 compliant with electronic signature capability. The system also includes modules for vendor management, to track vendor qualification and audits, and quality management, to document deviations, change control, CAPA’s, complaints etc.