Quality management systems (QMS) refer to the set of policies, procedures, processes, and resources that a company or organization puts in place to ensure that their products or services consistently meet or exceed customer requirements and expectations.
A QMS is designed to help organizations achieve their quality objectives by documenting best practices, focusing on customer satisfaction, continuous improvement, and waste reduction. It involves identifying and controlling quality-related risks, establishing and monitoring quality metrics, and implementing corrective and preventive actions when necessary. A QMS typically includes elements such as quality planning, quality control, quality assurance, and continuous improvement.
Owing to large scale digitalization in the last decade and the developments in cloud-based technologies, QMS have evolved to offer more than just a convenient place to store files that can be accessible from anywhere. They now provide far more in the way of collaboration, data analysis, and connectivity.
Yet, as regulatory requirements and technological developments keep evolving, quality assurance professionals face the challenge of selecting the right QMS software vendor.
Are you also struggling to find the right QMS software vendor? Then keep reading the article as we walk you through the 9 key points you must check with your QMS software vendor.
#1 Regulatory landscape for QMS
As a life sciences company, you have the obligation of meeting applicable regulatory compliances. Therefore, while selecting the vendor you should always specify these compliance requirements and standards. Generally, QMS must satisfy prevailing regulatory requirements such as 21 CFR Part 11 and EU Annex 11 and widely accepted standards such as ISO 9001:2015 and ISO13485:2016. Apart from that depending on your business activities you should also ask your QMS service provider about compliance with GDPR or other regional regulations that may apply to you. Before you discuss the regulatory compliance with the service provider, you must deeply study the regulations that apply to you, and also understand possible compliance conflicts that may arise in practice.
#2 Financial Cost of the QMS
While selecting a QMS service provider, you will certainly want to consider the financial aspects of the services. You may need answers to questions such as:
- Is it a one-time cost or a subscription-based cost for you?
- Are there any additional costs incurred for the cloud platform?
- How does the vendor ensure that the pricing policy is fair?
- Is the price inclusive of the implementation and training price?
- Is the cost of maintenance included in the price?
- Are there any taxes that will be applicable to the services?
#3 Functional features of the QMS
A QMS software for a life science company must have some common functional features across its all modules. These features include the following:
- Ability to differentiate documents into draft and approved version
- Ability to link these documents with other QMS objects
- Automated versioning
- Automated date assignment
- Automated page numbering
- Audit trail report
- Varied access levels such as creator, reviewer, and approver
Considering the nature of the manufacturing activities in the life sciences you should ensure that your QMS has provisions for monitoring and tracking the following activities:
You need a QMS feature for Document Control that will allow you to store Quality documents such as Quality Manuals, Quality Policies, Procedures, Processes, Work Instructions, and Templates.
Deviation/Incident Report mechanism
Whenever things go wrong as they always do, then you might need a system to report a deviation or an incident. You should have provisions for tracking the date, time, and sequence of events that lead to the deviation.
Corrective and Preventive Actions (CAPAs)
Additionally, as soon as a deviation or incident is reported in your QMS you will want to carry out a root cause analysis. Therefore, you must ensure that your QMS has provisions for identifying the root causes associated with the specific event. Based on the root cause analysis, you may want to plan Corrective and Preventive Actions (CAPAs) which will have features to assign actions to responsible team members and time track them. Your QMS should have features to link documents in the Document Management System, Deviations, and CAPAs to give a bird's eye view of the sequence of events.
You may want to change some of your processes when you wish to adopt new processes. In such a scenario you will need to create a Change Control document. Therefore you should ensure that your QMS has the necessary features for documenting the scope of change, risk assessment, and change implementation plan.
Audits are an inevitable part of the life science business. Therefore, your QMS must have provision for scheduling, and tracking internal and external audits with a provision for storing audit observations and associated reports. If all your QMS objects can be linked easily to show everything in one place then your auditors will appreciate it and they will use the same mechanism in preparing the audit report.
#4 Configuration or Customization Scope
Before you finalize your QMS SaaS provider, it is important to understand what part of the QMS is configurable and what part needs to be customized. Generally speaking, configurable QMS is better as it would relieve you of the burden of describing customization requirements and additional costs associated with it. Additionally, according to GAMP 5 regulations you may need to invest more time, money, and effort to validate a customized QMS over the configured QMS.
#5 Versioning and Upgrades
One of the advantages of a SaaS-based QMS is that the client obtains continuous upgrades as the SaaS application improves over time based on the client's feedback. The clients have a clear product roadmap of features that will be added to the system. However, validation should be done on a specific version of the software, and software upgrades cannot be pushed to production without updating the validation documentation.
Therefore it is important to understand how the service provider handles versioning and upgrades for keeping the software validated. Your service provider will mostly solve it by freezing the application version for a specific amount of time during which validation documentation is updated, after which the upgrade is pushed to production on a specific date. As a client though, you must make sure that you are notified of these upgrades ahead of time. Notifications should include a change list detailing the differences between the current version and the new version and the updated validation documentation which can then be used to update your documents before the go-live date.
After you procure the QMS, you may still need the service provider’s support for the maintenance of the QMS to keep it protected from cyber attacks or to monitor the storage space. Therefore, it would be worthwhile to make it part of your service level agreement. Activities such as regular backups, moving data, importing more data, and in some cases, system updates may be included in the maintenance contract.
#7 Data Security
Whether it is for GDPR under European legislation or for ensuring data integrity under FDA regulations, as a manufacturer you will be required to ensure data security for different reasons. It will be worthwhile to ask your QMS service provider how they will ensure the Confidentiality, Integrity, and Availability of the data. This may include understanding the vendor’s business continuity strategies, disaster management policy, data backup schedules, etc. You may also need to know if your data will be stored on independent servers or shared servers. How will the service provider ensure that an unintended person does not access your data?
It might also be helpful to consider developing a questionnaire that you use for selecting a vendor, one which includes questions about governance and system access (who has access to what, and which parts of the system, if any, might be inaccessible to the client), the amenability of the system to audit trails, the uniqueness of electronic signatures, and whether the documentation methods meet standards set out by governing bodies for compliance purposes.
#8 Implementation challenges
In 99% of the cases, the service provider who solves all your implementation challenges will be the sole winner. Purchasing a software service is one thing and implementing it organization-wide is the real challenge. You will need support from your service provider for old data migration, installation requirements (if any), database integration or single sign-on setups, and last but not least training.
One benefit of a SaaS-based QMS is the client’s ability to shift some of the validation burdens onto the vendor. When doing this, it becomes necessary for you to direct your internal audit onto the services offered by the vendor to ensure compliance with the governing authorities. Examine the vendor’s data center as well as their methods for quality assurance and validation to ensure that they meet or exceed the standard you as a client would have set for your system. A rule of thumb is that if you spend a few days auditing your vendor, you will most likely save a significant amount of time when it comes to auditing the entire system. The vendor audit is usually done at the vendor’s primary location, and you should expect the validation teams to provide any documentation and files for review that were developed as part of the process of designing, implementing, and testing the application.
Vendors should demonstrate that proper planning went into the development of their service to you. Accordingly, they should be expected to present documents such as functional requirements, business requirements, system designs, test scripts, test and validation plans, traceability matrix, and a validation summary report.
In conclusion, selecting a software vendor for your QMS is a critical decision for your organization. It is important to ask the right questions and understand the key points that must be considered before making a final decision.
Ensure that the software supplier understands your business processes and industry regulations. Ask about their experience in implementing QMS systems and the support they provide. Inquire about their approach to data security and data integrity.
Additionally, inquire about the software's flexibility to support changes in regulations and business requirements. Check the software's scalability and integration capabilities with other systems. Ensure that the software has a user-friendly interface, and ask about the vendor's training and support programs.
It is also essential to verify if your service provider's QMS complies with relevant international standards, such as ISO 9001, ISO 13485, and FDA 21 CFR Part 11. Lastly, review the software vendor's track record and references, as this can provide insight into their ability to deliver on their promises.
By asking the right questions and considering these key points, you can make an informed decision and select a software vendor that can help your organization implement an effective QMS system.