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      online quality management system (QMS) for ISO and GMP

      Ibiqs online quality management system

      Our Ibiqs online quality management system is an integrated suite of modules developed using SharePoint that streamlines, automates and allows the effective management of the quality processes that are required in a GMP or ISO management system environment.

      If you have to be compliant to GMP or an ISO management system standard e.g. ISO9001 or ISO13485, then you should have an efficient QMS. The days of manually managing documents, change control, internal audits etc. are over.

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      Sometimes organisations end up with a bunch of different software systems to manage each aspect of their QMS. They have one system for customer complaints, another for document management, and their change control system is paper-based. It may have happened organically, or it may have happened because different departments couldn’t agree on one system.

      After living with disparate systems for awhile they’ll soon agree that having an integrated electronic QMS is essential for everyone’s sanity. QikSolve’s online Quality Management System is based on Microsoft’s SharePoint and consists of various modules, designed to handle common quality processes.

      Standard Ibiqs Quality Management System modules

      Electronic document management system

      SharePoint is an out-of-the-box document management solution that is tightly integrated with your Microsoft Office suite e.g. Word, Excel, PowerPoint, etc. SharePoint can be quickly configured to provide different levels of control, and becomes an electronic document management system that houses and controls your business and quality documents. This can be hosted in a secure cloud environment, or on a server at your site.

      Corrective and preventive actions (CAPA)

      One of the key continuous improvement tools is any QMS is an effective CAPA system. This prevents the recurrence of issues, or stops them occurring in the first place. Our CAPA management module manages your CAPA documentation, tracks issues and provides metrics on your CAPA process.

       

      Change control

      Change control is a critical quality process that helps you to manage changes to your systems and processes, efficiently and effectively. Our change control module allows you to manage the creation, approval and actions associated with changes to your systems and processes.

      Audits

      Included in the QikSolve online quality management system is an audit management module that provides you with tools and workflows to manage internal and supplier audits; from audit planning and scheduling, through to documentation of findings and audit reporting.

      Deviations and non-conformances

      The deviation and non-conformance management module captures incidents and issues from anywhere. Issues such as process failures, exception events, adverse events or site incidents can be recorded. A detailed summary of what happened can be captured using a mobile-enabled form, along with important dimensional data to enable analytics and tracking. Workflows ensure the process is correctly allocated and consistent investigation actions are taken.

      Customer complaints

      An efficient customer complaints handling process is a key part of any QMS, and is critical in regulated ISO or GMP industries - especially where patient safety is at risk. The customer complaint management module enables you to efficiently track and manage your customer complaints.

      What are the advantages of using an electronic QMS?

      SharePoint is widely available, often for no additional cost

      SharePoint is widely available. This means that most often, users arrive into a new (your) company with recent SharePoint experience. It's most often supplied with the suite of Microsoft Office products i.e. Office 365, so even if your company isn't actively using it, it's probably available for no additional cost, aside from the set up and configuration.

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      Customisable and expandable

      Forms, workflows and reports are easy to customise in SharePoint. You can also add functionality by installing various plugins that are available online. SharePoint can become your whole-of-company software system managing everything from quality documents to staff recruitment. Alternatively, you can pull data from existing systems into SharePoint for use in dashboards and reporting.

      Centralise your data

      We've designed the Ibiqs online Quality Management System to enable it to pull in data from all your sources such as spreadsheets and data bases. It presents this data in customisable dashboards so that you can focus on your core business, and continuous improvement.

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      Quick access

      Quickly searching online to find a specific document is much quicker using SharePoint than trying to find a paper document in a filing cabinet (or a room -size compactus). Processes, such as quality audits, run more smoothly because you can easily find the information you are looking for.

      Access information from anywhere, anytime

      If your workflows are often delayed by people being out of the office then having our electronic QMS that can be accessed from any device, anywhere, will make life so much easier. Managers can review and approve forms and documents on their smart phones while waiting in airport lounges or in hotel rooms.

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      New templates are easy to implement

      Think about what you’d need to do to roll out a new SOP template across your organisation. With our electronic QMS you can change the template in one place, and have it roll out across the organisation automatically. You’ll never have to see the crestfallen face of an engineer who has just handed you his new SOP to be told it was in the wrong template again.

      Quick to deploy

      Our electronic QMS is pre-built and just needs to be installed on your SharePoint system; configuring them to suit your processes is quick and easy.

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      Centralised control

      All of your data and information is in one place. This saves time in hunting down documentation such as paper change control forms that have been circulated to many departments (....and gotten lost along the way). It also allows you to interrogate your data so you can see where bottlenecks are, and identify problem areas and problem products. This is difficult to do if your data is handwritten in forms or kept in spreadsheets on personal hard drives.

      Lower cost

      Our electronic QMS is built using Microsoft SharePoint – software that you probably already have or can get for very little additional cost. This reduces the upfront cost to you, to implement a new system.