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Michael Jovanis

Standards

Expanding Your Quality Management Technology Solution

What's better: Customizing legacy software or investing in a purpose-built system.

Published: Monday, December 21, 2009 - 07:45

Quality and IT executives alike face increasing pressure to implement technological solutions that allow the highest level of holistic control and oversight concerning the quality of their operations. This pressure is compounded by the current economic climate in which companies face constant demand to drive cost out of operations by eliminating redundant technology and supporting infrastructure. It’s imperative that the most effective decisions are made when reviewing alternate solution approaches to ensure that both quality and economic efficiencies are realized to the greatest extent possible.

A topic with which industry professionals have wrestled for a number of years is the extent to which they should repurpose existing software applications to manage quality systems processes. Central to this discussion is the question of how—or if—an organization’s enterprise resource planning (ERP) should be extended for use in the quality systems area.

The customization conundrum

Several trends have been prevalent in recent years that are changing the course of ERP deployments, due to lessons learned and the overwhelming pressures of economic uncertainty.

There has been a history of organizations extensively customizing ERP installations to extend their use into more traditional, transactional supply chain-oriented uses. For example, in recent discussions with a top life-sciences organization, it was disclosed that the company had more than 25,000 documented customizations in their “big name” ERP system. Though this initially seemed a positive practice for ERP vendors from a footprint and professional services revenue perspective, the trend has actually had a disruptive, negative effect, by creating full competitive-evaluation processes at the point of each upgrade.

As organizations execute these upgrades and re-implementations, they should exercise extreme caution before embarking on a path of costly customizations that will ultimately return them to the predicament they are attempting to correct. More frequently, this trend and refocused perspective are driving organizations away from the view that ERP platforms are a one-size-fits-all, solution. Prudent IT leaders now seek to leverage purpose-built applications for their intended functions to provide the fastest return on investment and time to productivity, and to help prevent mistakes made in past ERP implementations.

Effects of merger and acquisition on ERP

Due to trends within the economic environment as well as developments intrinsic to particular industries such as the life-sciences industry, we have seen an extended period of significant merger and acquisition activity. The net effect has been application landscapes within newly combined organizations that possess high levels of application redundancy and diversity. In healthy economic times, organizations usually “rip and replace” these redundant applications and pursue harmonized implementations as part of integration activities using merger and acquisition funding. But with respect to ERP systems, these harmonization activities are usually performed at a high cost from a deployment perspective, and stand as a significant disruption to the business, with very long and complex transition plans.

As organizations become more cost-conscious, many are now looking at alternatives that will enable them to prudently reuse their existing application landscape without having to endure the cost or disruption of a “rip and replace” decision. Central to this approach are strategies to bridge the multiple pre-existent ERP installations. Additionally, these organizations are pursuing and further leveraging adjacent enterprise applications that can effectively coexist in these heterogeneous environments. The use of commercial service-oriented architecture-based middleware applications is proving its usefulness in these scenarios by allowing appropriately designed applications to communicate effectively in an environment that may include a diversity of legacy application installations. An added benefit from a middleware bridging approach is the way organizations are finding newer ways to extract value and gain return on investment from their multi-application ecosystem—namely, in the area of business process automation.

Manual process activities that cross the boundary from one application to another, such as a quality systems application to an ERP application, can simply be automated using modern integration capabilities.

Can ERP support quality systems processes?

Certain elements of a quality system can be perceived as logical extensions of the functionality traditionally provided by an ERP. Corollary to this, benefit is gained from a product release process that enables clear visibility into all quality issues associated with a particular batch or product.

Several ERP platforms offer functions that are positioned as “quality modules,” or add-ons, for managing quality related processes. This functionality is typically designed to manage an isolated process of the overall quality system as outlined previously. Various types of deviations that appear during the manufacturing process can be logged against a particular batch within the ERP system and to a limited extent enable tracking of investigative activity.

This siloed approach to system adoption stands in obvious contention with mature industries, such as biopharmaceuticals, which take a holistic view of quality systems and the broad-reaching role of quality assurance organizations within their businesses. Over time, as the adoption of quality systems applications has become more pervasive across the different aspects of a quality program, the view toward these systems has been elevated to enterprisewide status.

Frequently, the goal and driver behind implementing an isolated component of an enterprise quality management solution is to provide visibility into quality issues at the time of product release. The reality—frequently only realized once engaged in these projects—is that the scope of data needed at the time of product release is much broader and further diluted across multiple quality systems processes, and even additional enterprise applications, than originally anticipated. This results in extensive customization work that must be done within the ERP to gain access to the additional information. For those that choose not to engage in customization, error-prone, resource-intensive manual workarounds must be established.

The implementation model for these systems is consistent with the approach taken in a broad range of ERP-related deployments. These are typically large-scale professional services engagements involving significant customization to enable the ERP to conform to the customer-specific product and quality process requirements. Even for a mid-tier biopharmaceutical organization, this isolated component of the overall quality systems landscape can cost several million dollars, easily equaling or exceeding the price of implementation of a complete, best-of-breed quality system application.

What EQMS provides

As a focus on electronic solutions for managing quality systems has emerged, adoption has occurred on a site-by-site basis and frequently for isolated point solution processes. Over time, the success of these systems drove their expansion from the plant level to the enterprise level while organizations also aggressively expanded laterally to co-locate all of the highly interrelated processes within and peripheral to the quality systems area. These processes span a number of functional groups, including supplier quality, manufacturing operations, labs, regulatory affairs, multiple auditing groups and even complaint handling.

With the increasingly global economy, an effective supplier quality management program has become even more critical. This discipline includes a holistic, end-to-end process from a request for a new supplier, through the qualification process and ongoing monitoring through structured, risk-based auditing programs. Nonconformances and product complaints are increasingly cross referenced to both materials and the suppliers that had provided them, allowing the true aggregation of all supplier-related quality information.

From a manufacturing perspective, there are a multitude of different product and operational incidents that must be captured. After the logging of these incidents, a thorough investigation must be conducted, followed by the identification of cause and the planning and execution of corrective and preventive actions. To allow true closure, a regimented process must be put in place to check the effectiveness of the remediation activities to make sure the issue doesn’t recur in the future.

As the supply chain becomes increasingly global, holistic change management processes have received continued attention. Change management is inherently linked to the volume of ongoing remedial action within an enterprise quality management system (EQMS) and will track all up-front requests and pre-authorizations, the implementation of the change, as well as the follow-up review and approvals before the change is put into effect. Also, critical to change management processes is the assessment of regulatory impact and the determination of the appropriate updates that must be submitted to the relevant health authorities. This is often a parallel series of activities that are being managed by regulatory affairs staff.

A thorough internal audit program spans a number of different areas, including manufacturing, labs, clinical operations, and environmental health and safety. Leading organizations that are looking to clearly prioritize risk within their business are now centralizing all of their auditing activities into their EQMS to ensure that they have a standard and consistent method for assessing risk and prioritizing remediation activities.

The EQMS doesn't end at the manufacture of the product. It extends post market to the intake, triage, and investigation of post-market product complaints. Issues identified in the field must follow the same regimented investigation, root cause analysis, and corrective and preventive actions as the earlier-mentioned premarket incidents and deviations. In a pharmaceutical environment, it is also important that a clear linkage be provided between the product-centric complaint handling process and the patient-centric drug safety case management. This concept is driving a trend to consolidate drug safety case management into a holistic quality system to ensure clear traceability between the customer complaints, the product-related investigations, and the patient-centric activities.

Although this discussion has shed light on the high-level components of an EQMS, each individual organization will have scope variations and business process intricacies unique to both their operations and the products they are manufacturing. As the true depth and breadth of an EQMS is unraveled, it becomes evident that it goes well beyond an extension of tracking a batch in a transactional ERP.

In the current economic environment, a significant volume of mergers and acquisitions has resulted in creating a complex solutions landscape. Enterprise quality management solutions have emerged as a bridging force in these busy environments by delivering flexible integration capabilities that can successfully interconnect many legacy systems while still ensuring a consistent, transparent quality system process. Flexible, interoperable web-services capabilities are proving their worth in allowing multiple integration points to be put in place in a diverse environment at manageable cost and effort.

Conclusion

Companies that leverage purpose-built EQMS solutions rather than customized ERP-based solutions will realize a faster return on investment and lower total cost of ownership. Dispersed quality functions will not look, feel, or function like a single quality solution, exposing organizations to operational inefficiencies, increased risk, and regulatory scrutiny.

Focused enterprise quality management solutions avoid costly and problematic customization of supply chain-oriented ERP or other peripheral applications.

Powerful visibility and traceability with the highest level of efficiency across the broad scope of quality systems processes are achieved through a true EQMS and cannot be achieved when functions are spread across multiple applications.

Modern EQMS can serve as a powerful bridging point in organizations that have been engaged in mergers and acquisitions, effectively interconnecting diverse enterprise application environments.

 

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About The Author

Michael Jovanis’s picture

Michael Jovanis

Michael Jovanis serves as vice president, Vault Quality at Veeva Systems. He has spent more than 15 years developing and designing quality solutions. Before Veeva, Jovanis served as vice president of product management and strategy for Sparta Systems. He can be reached at michael.jovanis@veeva.com.