The Dawn of Integrated QMS… Part 1
Making the life of a startup easier
As regulatory and standards compliance increasingly play a critical role in business success, integrated compliance tools remain a sore point. QMS systems are too often based on PDF documents being generated at the right time. The challenge for the user is knowing when that time is, and what form to use.
Larger enterprise QMS systems are usually massive expensive systems that require dedicated specialists to keep running and are highly unsuitable for smaller companies and startups, especially as they struggle with staffing issues and organizing the work. As such, QMS doesn’t rate very high on the priority list.
Enter, Integrated QMS software.
Integrated because it brings together the functionality of 5 major and comprehensive pieces of software together, including Project Management, Quality Management, Document Management and Control, Risk Management and Team Messaging. Each is a separate module that serves a particular purpose, but they are highly integrated and interconnected to create one framework, they smooth compliance experience and foster a culture of compliance.
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Why Project Management is the 1st software small companies consider to get, and why compliance can’t be done through them?
Project management is usually the first software that small companies, app teams and startups consider to track and manage a project. Although handy for regular apps, companies working on medical apps or apps requiring regulatory compliance, such as ISO or FDA QSR compliance, standard project management software is not the right option for them. Something is always missing… compliance is not just a simple project management.
True, some project management software’s can support workflows, which could lead to building a good compliance framework, but most startups and small companies rarely have the necessary expertise in-house to understand how to configure the workflows for that purpose, much less understand what is required for compliance to follow-through with them.
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How to identify a good DMC that is suitable for compliance purposes?
The next hurdle is a good Document Management and Control system. Not every DMC is suitable for compliance purposes, as certain controls are necessary to ensure certain documents critical for compliance purposes are first identified as such, then safeguarded. A project document approval process is not the same as a QMS document approval process for compliance purposes. A compliance QMS document approval process must include electronic signatures and a secure, unmodifiable, storage facility. Furthermore, compliance documents have to be readily identifiable, complete with history, version control, tagging, to name but a few of the essential compliance requirements.
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Team Collaboration and Cooperation can be used in QMS?
Then comes to team cooperation and collaboration. Although chat has become the default communication tool within teams, especially with the advent of Slack, Skype and now Facebook Workplace, these struggle to be plugged into the very projects and DMC that users are using. A classic compliance problem is a document shared within a chat is otherwise lost to compliance. Albeit you can always write a bot program to extract it, that chat conversation is not attached to the project in question for compliance purposes. A messaging app needs to ensure that what the chat itself and the documents within it are part of the project and are traceable.
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The bolt-on Quality Management type of applications are just half solutions
Then there are the bolt-on QMS type of applications. Whether added to either the project management software or duplicating it or connected to the DMC, this bolt-on app is still a separate app – it’s not integrated. Users are forced to think of how and when to use it. They are usually in the form of a PDF workflow where a PDF form is pushed through a workflow from user to user. Users have to have a high degree of knowledge of what to do and who to pass the form on to, the next step (if not predefined).
In an integrated software the modules are designed to work together, in a way to simplify the QMS steps for the user.
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The Risk Management based approach
Lastly is Risk Management. Both FDA QSR and ISO standards use a Risk-based approach to QMS. As such compliance starts with RM and regular PM software cannot provide the level of circular argument that an integrated RM module can provide to ensure ongoing assessment and re-assessment of Risk-based on the ongoing development and new information. An integrated RM module builds on the previous Risks and adds to them through the PM modules, project by project.
Integrated or bolt-on QMS? The main differences
These five types of applications usually exist separately from each other and although a great effort is made to bring them together, they are not a truly integrated app, with compliance as their ‘raison d’etre’.
No matter how good Slack, Skype or various other apps are at bolting on separate applications, the magic that is being integrated from the software DNA level, which can make it easy for team compliance is simply not there. It’s still a hack. And magic is what an integrated and interconnected application can deliver. An integrated QMS App combines and blends these five types of applications in support of compliance.
An Integrated QMS App should understand the compliance requirements and automatically trigger compliance actions at the appropriate time, then capture
the documentation to show it.
To be Continued ...