The life sciences industry is dealing with a variety of increasing pressures. The industry is facing greater cost pressures, especially in companies with less top-line growth, such as pharmaceutical companies with limited pipeline, medical device companies with lower margins, and slower growth businesses. Global authorities are continuing to increase regulatory scrutiny, and these authorities will examine disconnects in processes that could be resolved by integrating multiple systems. Organizations are also facing internal pressure to reduce risk across their operations. These trends result in stronger corporate oversight, the desire to eliminate redundant systems across the business, and an accelerated drive towards enterprise orientation from an IT perspective. As a result of both organic growth and growth through mergers and acquisitions, much of the industry today is tracking and managing data in multiple systems that are often times redundant. Many organizations have local or regional disconnected systems for processes that should be managed globally. Companies may have strong core systems, such as ERP, CRM, and QMS systems, that perform unique functions but are not connected to one another. Data transfer between systems often requires a person to copy data from one system and enter it into another – a practice that is inefficient, error-prone, and can introduce variability across corporate data.
Progression to an enterprise environment begins with moving from paper processes to electronic tracking to electronic point solutions to best-of-breed enterprise systems, such as a true enterprise quality management system (EQMS). Implementing an enterprise-wide quality system with harmonized data allows an organization to perform comprehensive quality checks on batches and products prior to release to the market. Information that would become obvious in hindsight becomes visible during the manufacturing process with true EQMS. Once an organization has deployed core enterprise systems, they are able bring these core systems together in an integrated environment.
Integration allows for the ability to share master data among enterprise systems, eliminating and preventing duplicate data. By interconnecting quality-related processes across systems, an event occurring in one system can automatically trigger a new record or other activity in another system. Disconnect points are eliminated because integration provides the ability to update a source system based on actions in another. Enterprise integration reduces errors, decreases compliance risk, eliminates non-value-add steps to increase efficiency, and supports M&A strategies to harmonize platforms and systems and drive out redundancy. Modern web services-based integration is scalable and easier to build and maintain than old point-to-point integrations.
In the context of a quality system, enterprise integration can share specific data between the EQMS system and other core systems.
ERPAccess to master data (product, material, and vendor information), batch release, return/repair processing
LIMS/MESAutomated initiation of records in the EQMS system that will track investigations of lab results/nonconformances
CRMAutomated initiation of complaint records in the EQMS system directly from the CRM system
EDMSAccess to controlled documentation or, in more sophisticated systems, fully managed document control
PLMTrigger engineering change orders as a downstream activity of a change process
All integrations can be done directly between the quality system and the individual enterprise applications or via middleware applications, which can streamline integration and establish reusable integration points.
Companies across industries find significant value in integration projects, including efficiency gains and elimination of error-prone disconnected processes. By utilizing flexible, powerful technology to enable enterprise integration, many companies are driving innovation through the combination of multiple systems in one realm.