Understanding, experience and technology for success
Despite the availability of off-the-shelf compliance and quality applications in the market, many organizations still choose to develop custom compliance software to support their unique business processes and reporting requirements in their environment. The cost of ownership of such custom applications is high due to long development timeframes and higher on-going maintenance costs. This paper suggests that using a compliance platform as a starting point dramatically reduces the cost of ownership of a custom-developed application. The paper also provides an important checklist if you or your organization is contemplating developing a custom compliance and quality application
Packaged Compliance and Quality Applications
Organizations are successfully implementing enterprise-wide compliance and quality systems to gain visibility and control over key quality processes across their operations and to ensure compliance with government regulations, industry mandates, company policies and internal initiatives. If quality is not managed in a systematic, enterprise-wide manner, it can result in line shutdowns, reduced employee productivity, higher internal costs, loss of key customers, and slower revenue recognition. Not achieving compliance with government regulations can lead to penalties, fines and plant shutdowns. Gaining enterprise-level visibility into key compliance and quality metrics is critical to managing risk and implementing continuous improvement practices throughout the organization.
An enterprise-class compliance and quality system enables companies to identify, track, manage and correct issues and exceptions in key operational processes. Such systems contain the following capabilities:
Off-the-shelf compliance and quality software are increasingly being implemented by large and small companies across various industries to address regulatory compliance issues (such as 21CFR part 11 or OSHA) or customer-mandated quality processes (such as implementation of QS9000 or TS16949 by suppliers in the automotive industry) or to support internal quality initiatives (such as an implementation of ISO9000 or six-sigma).
Why build custom compliance and quality software?
Many organizations have unique audit and corrective action processes that require collection of very specific transaction data. In addition, such processes may also have very unique workflows and reporting requirements and require integration with multiple proprietary systems for specific process data. These scenarios abound in a large-distributed organization when one is automating an audit of a service process or corrective action in a supply chain process or compliance reporting for a very specific industry regulation. It is also very common for a company that is implementing leading edge best practices to have very unique data collection and process workflow requirements.
As a result, off-the-shelf compliance and quality systems do not entirely map to such a scenario unless the application is heavily customized. Hence many organizations opt to build their own custom compliance and quality applications to support their unique data collection, process workflow and application integration requirements. In addition, some organizations may start with an off-the-shelf application and add custom modules to support a specific audit process or a unique regulatory reporting requirement.
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Key components of a custom compliance and quality software
Once an organization has decided to custom build their own compliance and quality application; they would need to incorporate the following elements within their custom application.
The custom application must support the ability to capture username, password and purpose-related data for any transaction and log that information for audit purposes. It should also provide automatic user lockout after a finite number of failed attempts.
Dashboard, Reporting & Metrics: The custom application needs to provide a library of key metrics and user configurable reports/dashboards that leverage the metrics and data to provide quick visibility into process status and performance. The custom application must also provide a reporting wizard and integrated capabilities for charts and in-context drilldowns.
If such capabilities were designed into a software platform, specifically created for compliance and quality applications, IT organization could reuse such objects and capabilities by building their custom application on such a platform, rather than defining, modeling and programming such capabilities from scratch in a custom application. Modeling and programming such objects can consume over 50% of the overall programming effort in an application.
Any custom application built on a compliance platform automatically gets access to all the common services defined within the platform. As a result, development of a custom compliance and quality application/module is practically reduced to defining and programming the process logic and user interface forms - the application/module leverages the platform for common services that it would have to build otherwise. We estimate that building applications on a compliance platform can save about over half of the initial development effort for a custom application and over 80% of the annual maintenance resource requirements for a custom application. As a result, organizations can build functionally-rich custom applications for compliance and quality at a dramatically lower “cost-of-ownership”.