Steve Cagle10.05.06
How Today’s Configurable QMS Platforms Reduce Costs
Steve Cagle
Today’s IT organizations undoubtedly are feeling the impact of the industry’s demand for new technology as a means to reduce risk and decrease the cost of compliance. As medical device manufacturers are faced with the challenge of establishing quality compliance management systems to meet guidelines issued by the FDA and other regulatory agencies, IT professionals are faced with the pressure of delivering effective solutions while keeping costs down.
Fortunately, many IT leaders have found ways to lower the total cost of ownership (TCO) of quality management systems as well as to respond quickly and effectively to developing business needs. Device manufacturers can reduce TCO of quality and compliance management systems by standardizing on a scalable platform, which provides intrinsic and extensive configuration capabilities.
Long-term Advantages Over “Modules”
Traditionally, software vendors have developed individual point solutions or loosely integrated a la carte software “modules” to address specific business applications. In the long term, this model works well for vendors but is expensive for the customer, who must purchase, install, validate and train its users on each separate module. Additional problems arise when no module is available for a given business need and the customer must find an alternative way of managing the process.
Forward-thinking companies now prefer strategic and flexible platforms, which can be deployed for unlimited compliance processes out of the box, with the ability to expand the base system. Systems with this flexible architecture offer firms the inherent ability to manage an unlimited number of business applications using the same software.
With a platform approach, the firm licenses one product and then configures it for any number of its own applications in addition to those that are pre-packaged out of the box. In this sense, the system offers unlimited modules, each having its own forms, workflow, security groups, business rules and users to support specific needs, while at the same time allowing for interrelated workflow and reporting where needed.
Quality and compliance management system platforms provide numerous benefits and cost savings. Licensing costs and reoccurring maintenance costs are reduced, as there is no need to purchase separate licenses for each application and subsequently pay for maintenance on each of these. Implementation time and costs are reduced as well and are more predictable and repeatable, since there is only one software program to install and learn.
One of the most important tangible cost savings is the significant reduction of validation efforts, because there is no need to perform installation qualification (IQ) and operational qualification (OQ) for separate modules—instead, only performance qualification must be performed for each application.
Ongoing benefits, which lower the TCO, also are achieved. For instance, since IT already has gained experience with the system during the initial deployment, it will be able to leverage its knowledge to streamline deployment of subsequent applications. Maintenance costs also are reduced, as upgrades are performed only once for the whole system versus module by module.
A perceived disadvantage of a platform approach is that there may be a “build” process that will require additional implementation time. While this may be an issue for some software vendors, other vendors have designed their software to provide the best of both worlds: out-of-the-box configuration for certain applications and the ability to configure the software for additional applications without limitation. The key word here is “configurable,” and following is a discussion about what that actually means relative to the software tool.
Reduced Cost and Complexity
Implementing a long-term solution requires flexibility to address changing business and regulatory requirements. Traditionally, vendors have addressed the need for flexibility in a rather inflexible way, namely by customizing their software or allowing customers to do so themselves. Software customization has proven to be both expensive and time consuming, requiring substantial validation efforts and high maintenance costs.
Configurable off-the-shelf (COTS) packages, on the other hand, can be configured for a specific function without changing code and without changing the database schema using built-in tools. The customer can implement changes to meet evolving business requirements without coding, scripting or programming.
One of the main benefits of a truly configurable package is that it involves less complexity. Implementing configuration changes is relatively easy, and there is no need to allocate highly technical resources, such as a database administrator or software programmer, to make changes. Furthermore, changes usually can be performed in minutes or hours versus weeks or months, thereby helping to facilitate rapid prototyping during implementation.
Configuration changes also should also survive upgrades, since all configuration information is stored in database tables. The vendor should guarantee all new versions are backward compatible, assuring the customer that there is no need to reconfigure the product after moving to a new version.
Again, one of the biggest reductions in TCO can be achieved from the savings in validation. According to the Good Automated Manufacturing Practice (GAMP) Guide for Validation, implementing a COTS (a Category 4 software category) does not require the customer to repeat testing already completed by the vendor, assuming the vendor’s quality system is adequate and the software is “standard” as opposed to custom developed for the specific customer. Validation activities can be limited to installation qualification and verification that the system can be implemented to meet specific user requirements. Furthermore, efforts involved with change control to the production system’s configuration are minimal when compared with requirements for customized systems.
While many vendors now claim to have configurable software, let the buyer beware. Some vendors use the term “configurable” loosely and according to their own definitions. For instance, some vendors use graphical user interface based tools to perform “configuration,” but these tools only generate code in the background. Others have a “scripting” language, which they purport to be a configuration language. Furthermore, some vendors also have a mix of configuration and customization methods and do not really detail where the line is. It is important that the IT organization evaluate the extent of the tool’s flexibility—ideally by providing real business scenarios.
Strategic Thinking
The need for electronic systems to support users in an increasingly regulated global environment will continue to place strain on IT organizations. To address this challenge IT managers need to think strategically and identify scalable and flexible platforms. Here are some pointers for evaluating QMS vendors:
• Ask how many unique business applications the software will support. Find out if separate software and additional licenses are required for different applications.
• Have the vendor demonstrate real business scenarios and watch the configuration process used to meet the scenario. Are all changes made the same way or do some require more complex methods?
• Talk to references to find out how much effort is involved in rolling out new processes and if configuration changes have effectively withstood upgrades.
These evaluation factors can help you effectively choose a configurable platform, which will enable your organization to reduce complexity, implementation timelines, validation efforts and ongoing maintenance activities. In addition to lowering the total cost of ownership, this approach will save on opportunity costs, enabling IT to deliver new applications and changes to existing ones, keeping pace with business and regulatory demands.