System for Pharmaceutical Manufacturers
GMP Compliance is an essential part of daily life in the pharmaceutical industry where ‘GMP’ is often referred to as ‘Get More Paper!’ However, with an intergrated electronic documentation management system, your Pharmaceutical Quality Management System (PQS) and your paper challenges will soon be solved. The integrated modules and best practice forms and workflows within Ibiqs make document management much easier than the normal paper route. The configurable Ibiqs package can also be deployed as a “GAMP category 4 software package” that complies with CFR Part 11 and provides an audit trail that can be neatly handled through workflows, Azure or Active Directory authentication.
The customer complaint module enables you to efficiently manage your customer complaints - an important factor in regulated industries where patient safety is the number one priority.
Our change control module allows you to track and manage the creation, approval and associated actions of critical changes required by your systems and processes.
The audit module provides you a way to manage both internal and external supplier audits. You can control the initial audit planning and scheduling all the way through to the final reporting.
Suppliers, can be easily managed and integrated into your audit program. Any documentation collected during the audit process is available for the supplier, as well as any associated deviations or non-conformances.
Deviations and non-conformances
This module can capture all the detail surrounding issues such as process failures, exception events, adverse events and even site incidents as well as track any recurring trends so you can be make proactive decisions.
Corrective and preventive actions (CAPA)
Our CAPA module provides a way to efficiently manage your CAPA documentation so you can stay on top of issues and view metrics on your CAPA process efficiency.
Electronic document management system
Ibiqs can quickly configure your existing SharePoint so that it compliantly houses and controls your critical business and quality documents in a secure cloud environment or server at your site.