What most organizations require is corporate-level, stringent process control.

Beyond the perennial concerns of profitability and competitive advantage, life science organizations have a number of responsibilities to carefully consider each day. Particularly in the area of environmental health and safety (EH&S), organizations must ensure the safety of their workers and test subjects, protect the community and environment from any hazards associated with production or development, adhere to governmental safety regulations, and maintain the integrity of their corporate brand. The complex manufacturing processes organizations have are designed to control the working environment to ensure quality production, high productivity yield, safety, compliance, and overall efficiency. However, sometimes the processes themselves are not flexible enough to guarantee these results.

Given these seemingly contradictory requirements, software vendors are developing solutions to address these issues. Today, there are modularbased software products on the market that promise to provide organizations with this level of support. However, these products often operate within the global organization as isolated, non-integrated technical systems that do little in terms of corporate centralization and process harmonization. Such programs fall short in perhaps the most critical element of EH&S. They fail to provide a holistic, macro view inside the inner-workings of the business to help ensure internal and external standards adherence.

This article will explore the myriad of business challenges manufacturers face, as well as current solutions many of them use today in an attempt to meet requirements. This piece will then discuss the adverse impact these ill-equipped “quality control” systems can have on the organization and what programs are available today to satisfy these complex requirements while maintaining a profitable, viable business and corporate image.

SAFETY CHALLENGES
Life sciences companies are at the forefront of advanced research and development and regularly work with new chemicals, processes, and manufacturing methods. These green-field approaches often lead to new discoveries that can offer a profound benefit to the world. Still, these innovative discoveries do also come with a certain amount of risk — i.e., potential harm to those performing these tests and the subjects of those experiments, as well as public safety in terms of potential environmental hazard. When a manufacturer identifies a weakness in the area of equipment, process, or chemical testing, it is imperative that the problem stops there before causing further damage. A centralized EH&S quality management system can help stop these potentially damaging developments in their tracks, across the organization. In turn, this will minimize the negative impact on all internal and external constituents.

For example, imagine if a clinical technician found a breakdown in a critical testing process in a cleanroom, and was unable to efficiently and effectively communicate this to his or her counterparts across the global life sciences organization. Unfortunately, this happens all the time. When such a problem occurs, the department affected is only equipped with the communication and safety documentation equipment necessary to inform those within earshot. Those employees working in similar facilities and testing environments across the world would never get the benefit of receiving the same critical information. It is quite easy to see how such a safety and drugdevelopment integrity problem could then propagate throughout a large, international company posing serious risks to all involved.

ENVIRONMENTAL/COMMUNITY HAZARD
Life sciences organizations work with dangerous materials on a daily basis and have strict policies and procedures with which to dispose of such waste safely. Nevertheless, sometimes the risks posed by these dangerous elements lie beyond the control of those tasked with handling them safely. Take for example a drug development services company that was using poorly constructed protective packaging to transport highly sensitive drug samples from one location to another. Workers noticed infiltration during transport that would compromise the viability of the sample. If this problem was not caught in time, the implications to a large study could be very serious causing delays, increased costs, and perhaps safety concerns. Now imagine this exact same process, under these very same conditions, was taking place across the company’s 36 other global facilities simultaneously — unbeknownst to those working closely with it. It is easy to see how problematic such a situation could become if not handled efficiently and properly in a centralized and standardized manner.

If this organization had an integrated environmental health and safety management system that consolidated and shared all such reporting across the company in a streamlined, centralized fashion, any problem could be reported, shared, prevented, and corrected before it ever becomes a widespread disaster. Without such a system, this type of problem could have a negative impact that could easily spiral out of control.