|Beware of a multipurpose tool that claims to be a
best-of-breed quality management platform.
See if the software addresses six critical quality areas.
When we invest in tools, we naturally want the most bang for our buck. Who hasn’t tried to use a screwdriver as a pry bar or a pair of pliers for loosening a bolt when a properly sized wrench would be more appropriate?
Let’s apply this scenario to ERP systems. They are excellent for functions they are designed for like inventory management, procurement, and financials but many organizations use them for other things like document control and other quality-system functions that they aren’t designed for.
Multipurpose Tool vs. Best-of-Breed Modules
I am going to refer to word processors used as spreadsheets or ERPs used for document management (or screwdrivers used as pry bars) as multipurpose tools. I will refer to software designed for an intended purpose as best-of-breed (BoB) modules.
Almost all enterprise software systems offer tools designed for specific functions. So in a sense, they might all be classified as best of breed for something. And virtually any software tool can be used for other more utilitarian purposes, so all packages might also be classified as multipurpose tools.
The assumption is that all other things being equal, best of breed is always better. And the closest we’ll get to software utopia is with an integrated platform of best-of-breed applications. So, how can you tell if a software package is a best of breed for a specific function, or if it’s a multipurpose tool with some capability to perform such a function?
This article is related to the White Paper:
How to Tell a Best-of-Breed Module
If you’re looking for a best-of-breed platform for quality management, go over the features of a solution and check if it has the capabilities to manage the following six quality areas. Make sure the processes are seamlessly integrated within a single platform.
1. Policy, Process, and Product Definition: A good quality system must have policies, procedures, and product or service specifications well documented before the organization can build and deliver a quality product or service. This type of documentation requires a system built for document management with the ability to electronically approve, manage document life cycles, manage security and document access, and distribute the proper documentation to all stakeholders.
2. Training Management: Regulated companies are required to ensure proper training through SOPs, work instructions, manuals, and other materials, and to document and maintain individual training and test records. A well-designed training management system should be able to document training requirements associated with job functions, automate the delivery of training materials to the right people, conduct testing for competency online, and capture all those records.
3. Quality Monitoring and Audit: Most regulations require audit as a tool for continuous improvement. Your system should keep the process visible to auditors and should give you the capabilities to manage audit schedules, lists of auditors qualified for different audit types, and standards and criteria.
4. Quality Event Management (QEM) and corrective action and preventive action (CAPA): A good QEM system will provide a mechanism to document events (e.g., deviations, customer complaints), capture pertinent data for tracking and trending, manage the process designed to correct the issues, and perform root cause investigation that will prevent such events from reoccurring.
5. Supplier Quality Management: All of the aforementioned functions apply to supplier management. A best-of-breed supplier module will have the capability to manage the process of selection, qualification, and periodic review of suppliers, manage supplier quality events and supplier corrective actions (SCARS), and measure a supplier’s performance through scorecards.
6. Change Management: An effective system should have the capability to effectively and efficiently document and manage change. It should automate the process for collecting and tracking data from the time a change request is submitted through the close of project. It should identify change types or categories and capture impact assessments.
Many software providers claim that their solutions address the things we’ve discussed above, but at closer examination, they are designed primarily for one purpose (such as document management, change management, or audit, etc.). They are multipurpose tools that generally do a good job about one thing but lack important features to address each of the six critical areas.
I suggest including two other less tangible factors for consideration. First, talk to the vendor’s customers and find out how they are using the system. Second, ask the vendor about its product development strategy and investment. If a vendor is not investing heavily in product development, then it indicates that its approach is more toward providing a multipurpose tool.
Paul Sanderson is the head of MasterControl’s Solutions Consultants Group. He has spent the last decade helping almost 200 regulated companies choose the right eQMS based on their unique needs and implement it successfully. He has 10 years of enterprise software experience in the life science space.