Are your aging Quality Management Systems (QMS) and the problems that come with them keeping you up at night?  Upgrading your QMS requires a commitment of time and resources. In order to make the best use of this investment, there are several areas to consider before you upgrade.  You will want to identify the requirements of the QMS, the processes involved, and the best technology platform to meet your needs.

Quality Management Systems Requirements

The complexity behind upgrading a QMS can be deceiving. Many QMS offerings today seem straightforward. However, it’s recommended to start by ensuring all stakeholders’ full understanding of the QMS requirements and expectations.  Input from all impacted groups and consensus of approach will be critical to success of the project.  Consider how you can build an inclusive culture where all employees feel involved in the process of recommending improvements to the QMS.

Equally as important to understand is your regulatory environment.  Think about your industry and the regulatory agencies that apply (I.e. FDA, EMEA, etc.).  You may need an FDA compliant or ISO-certified software-based QMS.  Consider feedback received from internal audits of specific areas or requirements that need to be addressed.  Be sure to do a gap analysis to compare identified regulations against your current capabilities.

You should also consider your validation needs and capabilities.  Evaluate if your validation team can support the work required to maintain and update a stand-alone QMS.  Some firms obtain the support from the QMS vendor or utilize outside consultant expertise if they do not have the internal capability for validation and implementation. Many organizations opt for cloud-based QMS to reduce validation requirements for routine maintenance and updates, but even these solutions come with complexities that shouldn’t be minimized when scoping an upgrade.

Quality Management Systems Process

It’s rarely advised to jump straight into upgrade activities without first analyzing your quality management processes.  Review your quality system workflows and your quality management model to determine if they are still appropriate or if you need to adopt a new approach.  Execute a Data Integrity Assessment and ensure your system and process is free of any “bad data”.  The future system must be capable of analyzing and trending data to generate information for analytics, metrics, and reporting, so you will want to start with clean data.  It is best to optimize the Standard Operating Procedures (SOPs) and data entry requirements that support the quality system processes before you select the computer system.

After quality management processes are analyzed, it’s recommended to assess scope and methodology.  Consider the organizational areas you would like to include in your closed-loop quality system.  Think about the QMS modules you would like to include such as deviations, CAPA, product complaints, laboratory investigations, documentation, regulatory submission information, and similar items.  Modern QMS applications are highly integrated, and you may be able to include areas not previously a part of your system.  These agile systems are scalable, so they eliminate the need to start from scratch when the business expands, or your quality process evolves over time.

Quality Management Systems Technology

Once you are confident that the quality management processes are thorough and effective, turn your focus to the current technology enabling QMS for your organization.  Is a wholesale replacement necessary or would an upgrade suffice?  Evaluate the capabilities and remaining useful life of your current systems.   There may be restrictions in vendor support as systems age, and upgrades may not be possible.  Consider if there are components you are currently using that could be leveraged or incorporated into a new or upgraded system.

Next, assess your infrastructure requirements.  Determine whether this will be a stand-alone system, part of a larger system or global QMS, or a fully integrated Enterprise Quality Management System (EQMS).  There are many benefits from a cloud-based architecture so this option should be evaluated.  Consider giving your organization mobile access to the QMS.  The ability to access the system from mobile devices is a great benefit to users.  Consider if you need to have the ability to share information with outside parties.  You may need to update your IT infrastructure to handle these additional capabilities.

Technology is only as good as the outputs it can produce, so consider expectations surrounding data insights and analytics.  One of the powerful benefits of modern quality management systems is the ability to support the conversion of data to information, from which dashboards and reports are generated and published.  Think about the analytics, reports, and dashboards that you do not have today that may be available in a new QMS.

The Bottom Line

The process of requirements gathering, current capabilities assessment, developing improvement ideas, and identifying technology considerations can be difficult and time-consuming.  When the time is right for a Quality Management Systems upgrade or replacement make sure you are able to utilize resources who can support you throughout process so your upgrade can meet your needs and provide the best return on your investment.

Co-authors Susan Shockey and Randall Jacobs.