By Mike Jovanis
With reports of supply quality failures making front-page headlines almost daily, quality issues are proving disastrous for global life sciences companies and their stakeholders. For this reason, quality management has quickly moved to the forefront of priorities for both life sciences companies and their stakeholders. More than ever, global life sciences organizations are required to proactively address their supplier quality issues before incidents arise that can do irreparable damage to their reputations, businesses, or — and most importantly — the well-being of the patients they serve.
With the advent of global supply chains, companies are constantly faced with ensuring product quality from product development through to the consumer. Executives need to take a greater role in ensuring that supplier relationships are effectively maintained and that the correct procedures are in place for gauging product quality and evaluating processes.
Centralized, enterprisewide systems must be implemented in order to stave off quality issues associated with production processes and procedures. Enterprise software systems on the market today can provide this level of management and control and, in turn, even improve productivity, reduce production costs, help ensure compliance, and ultimately reduce risk.
These tightly integrated, comprehensive systems work to evaluate incidents and changes in the broader manufacturing process as well as manage, track, and record them to ensure product quality — not simply within siloed departments, but across the entire enterprise. These systems also provide the necessary level of automated communication to those people affected by the change, as well as those responsible for overall product quality and business objectives. With such macro-level harmonization come significant business enhancements such as higher-quality production, more robust R&D, increased operational efficiency, reduced costs, faster time to market, and compliance with all necessary external requirements, both governmental and consumer-driven.
Compliance Pressures And Business Imperatives
In the wake of major product recalls, tarnished brand images, and faltering corporate giants, we’ve seen a dramatic increase in stricter governmental and consumer-driven controls for ensuring quality production and product safety. On the regulatory side, there are countless agencies — FDA being only one example — striving to enforce quality.
While these regulatory policies are clearly designed to protect the public from any undue harm, they can also consume a life sciences organization’s precious limited resources, potentially leading to production delays, missed market opportunities, inflated costs, regulatory violations, brand pressures, and lower profitability.
A centralized, enterprisewide quality control and regulatory compliance mechanism solves many of these business challenges, ensuring that quality management drives rather than hinders the company’s bottom-line objectives.
Quality Management Solution Deficiencies
All large manufacturers around the world face quality and compliance issues every day, and many have already sought and deployed centralized software systems to mitigate these challenges. However, a surprisingly significant number of manufacturers across the globe still rely on homegrown, paper-based, or disparate and departmentalized point solutions to serve their needs. These solutions place obvious limits on scalability and effectiveness. From an executive standpoint, these solutions simply don’t cut it in today’s global economy. As an organization grows, either organically or through mergers and acquisitions, so does its need for an enterprisewide quality management solution that can scale along with it and continue to meet and exceed its requirements. Many of the inadequate solutions currently in use do not provide the level of support these organizations need. Here are just some of the ways in which legacy systems fall short:
These fundamental disconnects and deficiencies are at the very core of why so many organizations face significant quality and compliance challenges that threaten their ability to successfully control quality management and compliance initiatives across the global enterprise. Recently the industry has seen major drug manufacturers being reprimanded by the FDA for failing to follow consistent manufacturing processes in compliance with the agency’s current Good Manufacturing Practice (cGMP) standards. These standards, designed to control quality and minimize risk in the broader manufacturing process, affect not only siloed manufacturing sites, but also companies’ reputations. Once the FDA warning letters are issued, companies have to scramble to comply with the mandate as well as to control the damage from the reprimand. This should be a warning to life sciences organizations — no matter how prepared you think you may be to manage audits within your organization, problems can still arise that can significantly hurt the business and set product innovation back months or even years.
EnterpriseWide Quality Management
Adherence to quality, regulatory, and consumer standards in life sciences is a business imperative that demonstrates its value by satisfying requirements, successfully powering innovation, reducing costs, and driving sales. The only true means of accomplishing this enterprisewide challenge is with a centralized, standardized, and enterprisewide quality management system to manage global initiatives and business processes.
When seeking a centralized system, there are a number of factors to consider, primarily in the areas of management visibility, product improvement, and process efficiencies. Ideally, such a system should offer:
Visibility Into Trends, Improvements, Risks
The aid of a standardized, centralized, and holistic enterprise-wide quality management program can help a life science company stratify, streamline, and take advantage of the tremendous benefits such an array of resources can afford if managed correctly. The result comes in the form of better, more innovative products, improved quality, consumer confidence, and ultimately, greater competitive advantage.