You’ve decided it’s time to improve your quality processes with a quality management system (QMS). But how do you know which one is the right one for your company? After all, not every QMS is identical.
We put together these 10 important questions you need to ask each vendor about their QMS.
The 10 Questions
- Is the QMS Cloud-Native?
- Does this QMS support “dynamic workflows”?
- How long does validating and putting the QMS into production usually take?
- Can the forms used in this system be easily used to generate well-formatted records?
- Is the QMS designed for life sciences, and does the system meet all pharma regulatory requirements?
- Does the application include a dashboard view of all incidents, their current stage, and their timeline?
- Does the QMS generate automatic email notifications triggered by key events and actions?
- Can data from other systems and equipment be integrated into this QMS?
- Does the system include support for audit activities?
- Can the QMS manage and track SOPs and related quality documents?
Is the QMS a “Cloud-Native” Solution?
Over the last twenty years, computer-based Quality Management Systems have evolved through several distinct phases. Some of the most well-known alternatives were built for the prior generation of on-premise technologies and, while available in a cloud-based configuration, are not optimized for it.
This tends to show up in two ways. The first is in the ease of use of the system. “Cloud-Native” solutions take advantage of the latest advances in user interface design and require far less training effort and onboarding time. They are also much easier to deploy and configure, dramatically reducing start-up time and effort.
So check out the history of the QMS you are considering. Find out when it was built and whether it was built as a cloud-first, cloud-native application because you should not invest in a solution built on technologies that became obsolete a decade or more ago.
Does this QMS support “dynamic workflows”?
Workflows After an initial deviation or out-of-specification is created in a QMS, the answer to “what happens next” is a huge “it depends.” It depends on the incident type, processes, and departments involved.
That means that the QMS needs to determine the next step – and each step — in the process based on various parameters that are collected as the scenario evolves. And you must be able to configure the system based on your processes, whether sending a notification, starting a new investigation, or initiating a corrective action.
An overly rigid or simplistic workflow model will frustrate you when you try to implement it with real-life processes. That means it is essential to ensure that the system you are considering includes the ability to execute a variety of workflow patterns and that the “next” step in a flow can always be based on the actions taken in “this step.”
How long does validating and putting the QMS into production usually take?
If you contact references and collect information about the “time to production” on five QMS applications, you will hear about timeframes from as fast as one month to as long as six months. That is a huge difference, and the longer timeframes waste tremendous resources and increase the possibility that the implementation will fail.
Older systems are more “hard coded,” and changes to address your processes will dramatically slow implementation. A modern QMS should be able to be in production within 6 to 8 weeks at most. The system you want will be pre-configured with standard processes that can be easily changed to match your needs.
Part of the benefit of cloud-based systems is that they are typically “pre-validated,” meaning the base system has gone through the complete validation process, leaving only a final set of user acceptance tests to complete the validation.
Can the forms used in this system be easily used to generate well-formatted records?
There are two distinct use cases in a QMS. One is when the incident is active and being tracked. During that time, you want a simple way to update the information about it as it progresses through the investigation, the corrective action, and each subsequent phase. Simple, clear forms are the solution.
For the second use case, however, those on-screen forms are inappropriate. That use case is when you create records of the incident on paper or for export from the system. In this case, you want well-formatted documents that include the same information as the original forms but look like paper documents.
Choose a QMS that addresses both use cases effectively so that users don’t have barriers while the incident or issue is active. Then, effective documents can be generated to meet reporting needs when needed.
Is the QMS designed for life sciences, and does the system meet all pharma regulatory requirements?
A QMS for life sciences must meet requirements related to managing electronic records. That includes, among other things, a full audit trail of every action and the ability to leverage electronic signatures as part of approvals.
Choosing a QMS explicitly designed for life sciences will save you time on implementation and ensure that regulatory requirements are addressed. Some QMS solutions are more generic and marketed for use across many industries. Those systems will require more time to be configured to address the specific requirements of a pharma company and may have gaps in the features they offer to meet pharma regulations.
Another benefit of a system focused explicitly on pharma is that it should be able to manage several processes other than the traditional incident <CAPA> Change Control process. The QMS should also address pharma processes such as documenting supplier qualifications, managing out-of-specification issues, and handling internal and external audits.
Does the application include a dashboard view of all incidents, their current stage, and their timeline?
We are moving rapidly into the fourth generation of Pharma manufacturing technology, and one of the hallmarks of Pharma 4.0 is the “datafication” of every aspect of the manufacturing operation.
That means a modern QMS must collect, consolidate and report on all the activities it tracks. The QMS you want today will do it with a dashboard-style interface that allows you to select key performance indicators (KPIs), set targets for each, and choose from graphic options (bar chart, pie chart, donut, etc…) to present the results.
Ideally, it will also allow the configuration of individual dashboards for different users so that each user sees the KPIs and other information most relevant to their role.
Does the QMS generate automatic email notifications triggered by key events and actions?
A quality management system’s fundamental purpose is to ensure that a consistent series of steps is followed from beginning to end for every issue, incident, complaint, or finding. Notifications are critical because they make the required participants aware that an item is awaiting an action required by them.
A notification within the system, such as a queue on the user’s application homepage, is nice but insufficient. For many users, the QMS is not where they spend a lot of time, so you need a way to notify them, such as an email or text, of items that require their attention.
Ensure that the QMS you select offers the flexibility to allow users to set how they want to be notified and how often. In addition, a nice-to-have is a daily summary page of all required actions in addition to individual notifications.
Can data from other systems and equipment be integrated into this QMS?
In the world of Pharma 4.0, systems and equipment are integrated and exchanging information. That means that the QMS you want today has to be able to connect to other systems and devices, collect data from them and share information back.
As a result, the QMS must provide a Rest API (Application Programming Interface), the current technology for interconnecting disparate systems.
There will still be some work to connect disparate systems, but the availability of a Rest API ensures the QMS can interact with other systems.
Does the system include support for audit activities?
Audits and inspections are a fundamental part of the quality process in every pharma company, so your QMS should have specific functionality to support them.
That includes scheduling an audit, building an audit work plan, recording findings and follow-on actions, and preparing a polished audit report.
The system should be able to specify the type of audit as well, for example, internal or external, and the scope of the audit.
Can the QMS manage and track SOPs and related quality documents?
The focus of most QMS applications is on tracking the quality process, from incident to investigation to CAPA and through to Change Control. But another critical element of managing quality in a pharma company is managing a complete set of quality documents.
Some systems do this within a single application, but others have a companion application for managing quality documents, which is perfectly fine. The key is to have the flexibility to manage not just SOPs but also work instructions, vendor documents, and other quality documents.
Essential features include creating new quality documents from templates, controlled access to the documents based on roles, a review and approval workflow, and version management of each item as it progresses from draft to final version.