Sometimes through no fault of their own, organisations can end up using a variety of software systems to manage different aspects of their Quality Management System (QMS). Not only is this horrifically confusing but it is also incredibly inefficient!
To solve this problem, we’ve come up with Ibiqs, an online QMS composed of an integrated suite of core modules. Developed using SharePoint as a backbone, it allows for the streamlining and effective management of the quality processes that are required for organisations which have to be compliant to GMP or ISO standards, e.g. PIC/S, ISO9001 or ISO13485.
Standard modules provided within the Ibiqs QMS
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.
What are the advantages of using Ibiqs?
Workflow and permissions
You can minimise the administration time spent chasing actions to close out audit findings by using the workflows within the ISO and GMP modules. You can see at a glance who has a specific action waiting for them to complete and also send reminders to those who have still to complete actions.
Ibiqs can capture the date, time and user information for all documents accessed and edited automatically. With every version of a document automatically archived, a complete historical record is available for legal, compliance and auditing purposes. Also, as everything is online, there's no risk of losing crucial reports or having to chase down a papertrail.
The Ibiqs QMS is tightly integrated with the Microsoft Office suite, thus allowing users to work on documents together with familiar tools. Document check-in and check-out ensures nothing is overwritten and version control allows you to roll back to a previous version easily.
SharePoint’s extensive analytics and reporting capabilities allow you to pull data from all your QMS sources and present it in customisable dashboards so you can focus on your core business and continuous improvement.
Ibiqs is web-based which enablies employees to securely login and access it from anywhere. You can also allow anonymous access via a form on a webpage, so suppliers or customers can submit information that automatically goes into the audit management workflow.
You can ensure the consistency of your QMS documents by controlling them with a centralised document template. Any approved change to a core template will be automatically rolled out on active documents, cutting out a significant portion of time.
Customisable and expandable
You can edit the look and feel of SharePoint as well as add functionality by installing various plugins that are available online and compatible with SharePoint.
All of your data and information is in one place which makes for easy searches as well as the ability to control user and access permissions for each document.
21 CFR part 11 configuration comes out of the box. We can also tailor the process to simplify compliance with the requirements of ISO9001, ISO14001, OHSAS18001, AS4801, and others.
Ease of use
Ibiqs is simple and intuitive to use and there's no need to install any new software and re-train employees, just a quick update on functionality and away you go!
Because Ibiqs has been built using Microsoft SharePoint, this reduces the upfront cost to you to implement the upgraded system.
Because SharePoint is widely available and often supplied within the Microsoft Office suite of products, this allows an easy fusion of Ibiqs into your existing applications.