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In a discussion about pharmaceutical supply chain management, we must first discuss the challenges the industry faces. Take compliance. The pharmaceutical industry is highly regulated, and a single quality event or poor reporting could result in a recall or penalty. Pharmaceutical recalls have gone up tremendously in the last few years due to many factors, including the FDA cracking down on compounded pharmacies and enforcing GMP standards. According to the Regulatory Affairs Professionals Society, pharmaceutical recalls in 2013 and 2014 were almost as much as the previous nine years combined.
Stronger enforcement of regulations is only one challenge though. The pharmaceutical industry is becoming more global and, therefore, more complex. Did you know that IMS Health data indicates that China is now the third largest pharmaceutical market in the world? Countries with emerging markets are poised to see major growth in the next few years, while older markets may see reduced revenue. Companies are outsourcing more than ever before.
This is problematic because, although cost-saving, outsourcing can create more complicated quality issues. In fact, according to a Deloitte Recall Report in 2010, more than 50% of all pharmaceutical recalls were due to issues with the supplier or Contract Manufacturing Organization (CMO).
Because of these stakes, more companies are investing in enterprise quality management systems (EQMS) that can help them gain efficiencies and achieve compliance by integrating related events and actions, automating workflow, and facilitating trending and reporting across quality systems. Some of the industry leading EQMS platforms also offer processes that can seamlessly connect external third parties to a company’s internal processes. Manual, disparate systems all too often result in more errors, poor communication, greater waste, supplier issues, and delays in getting a product to market. They can also affect audits and regulatory compliance.
To provide greater insight on how EQMS software can improve quality processes, please check out this case study where quality management software was implemented for a pharmaceutical company in need of better reporting and compliance.
EQMS software enables holistic supply chain management, which is crucial. Think of the body. When there is a problem with one part of the body, it can affect the body as a whole. The same holds true for a supply chain. EQMS software can help an organization manage the supply chain at all levels as a whole to ensure everyone is on the same page.
What Should I Look for in EQMS Software?
When shopping around for EQMS software that supports a holistic approach to supply chain management, management should look for products that have these qualities:
– Manages all quality control processes in a centralized database
– Enables site level, process level and role-based security
– Streamlines workflow processes
– Leverages powerful status reports and metrics using an integrated report generator
– Meets regulatory requirements with support for electronic signatures and record and configuration level audit trail
– Makes changes to the system seamlessly using point-and-click configuration tools
– Configures workflow quality systems management tools with no need for customization
– Can be upgraded seamlessly and cost effectively
– Has been used successfully by organizations in your industry
– Is easy to use and can be accessed anywhere for real-time reporting and tracking
