While many pharmaceutical and biotech companies have begun investing in their quality systems, it’s not uncommon to still find mid-size or emerging manufacturers manually entering data into spreadsheets or using siloed systems that are unable to share information electronically.  

Emerging and mid-sized companies, often already short on resources, must closely monitor expenditures related to contract manufacturing services and strategic partnerships, all while keeping an eye on regulatory compliance. Yet, few have sought the benefits of implementing a quality management system (QMS). Such a solution is fully integrated, automates processes like event tracking and audits, and creates a single source of information that can easily be accessed and mined.  

Key Capabilities of an Integrated Quality Management System  

Advances in technology have enabled the ability to acquire data from more sources both within an organization and outside of it. Technology costs also have eased, making quality management software more accessible and easier to maintain. Additionally, integrating a quality system into the manufacturing process can alert manufacturers when production standards are not being met and corrective action needs to take place. A QMS can also integrate and streamline the manufacturing processes across production facilities, geographic locations and newly formed or merged organizations, thereby driving higher operational excellence and reducing cycle times. 

Large pharmaceutical companies are moving in the direction of using big data and predictive analytics to pull and process information that had previously been siloed in different systems. But perhaps one of the best near-term benefits of quality management software for mid-size and emerging organizations is one that migrates data from separate silos like quality, manufacturing, post-market surveillance, and R&D into a single global system. 

The Impact of Quality Data on the Supply Chain 

The QMS also has the ability to target one of the biggest challenges facing pharmaceutical and biotechnology companies—the supply chain.  

Companies use quality systems to look at what has happened with suppliers in the past, determine if they are at risk and take preventive actions, such as making provisions to find new suppliers. A good system can assess suppliers regularly and generate supplier scorecards and risk index. 

Buy-in from senior management is also integral to the successful implementation of a quality system as well as the development of quality key performance indicators (KPIs), identification of stakeholders, goals, and timelines. While the KPI can be a subjective goal, it is not a subjective measurement.  

Reaping the Benefits of Digital Quality  

The implementation of a new quality system is a strategic question that can vary depending on the size of the organization. Yet, given the complexities of the industry, data integrity is a sustainable competitive advantage.  

Download the white paper for more insights into four areas where quality benefits operations— process, operations, supplier quality and effectiveness.