Data integrity issues in the manufacturing of finished pharmaceuticals and active pharmaceutical ingredients (APIs) continue to be in the spotlight. Life sciences companies are under increased scrutiny by regulatory bodies, as the MHRA, FDA, EMA and WHO have all recently issued guidance on best practices for end-to-end management of data records throughout the drug development lifecycle. Yet with this heightened awareness and an increasing number of data quality citations, few life sciences companies have taken substantial measures to improve their data integrity processes.
There’s a lot of confusion in the marketplace with regard to what data integrity entails and how to go about capturing, tracking and monitoring the information. The FDA defines data integrity as “the completeness, consistency and accuracy of data,” and emphasizes that data must be attributable, legible, accurate and documented at the time that a data-driven event takes place. In other words, every piece of data generated across all processes, facilities and individuals related to the manufacturing of a product must be maintained in a detailed audit trail at all times.
While many companies outsource manufacturing, it is the license holder that is ultimately held accountable. Data integrity issues can result in the removal of drugs currently on the market or a delay to the release of new drugs, adversely affecting the ability to deliver critical treatments to patients.
Assuring data integrity across multiple suppliers, countries, and different modes of communication is becoming more complex and resource-intensive. The good news is that modern cloud technology can harness all of this data and improve collaboration across all parties involved, and ultimately, help life sciences gain control throughout their supply chain and strengthen data integrity.
CURRENT CHALLENGES TO QUALITY DATA
A combination of factors has inhibited the industry from effectively carrying out the best possible data integrity practices:
Complex supply chains: Companies often outsource many aspects of drug manufacturing. A company may manufacture a finished drug, but the active pharmaceutical ingredient could have been developed and mixed into the product somewhere else. The U.S. takes the lead in outsourcing, with 80 percent of active ingredients and 40 percent of finished drugs manufactured in other countries for greater efficiency, cost savings and speed to market. As the supply chains expand, a company’s ownership for all data streams becomes greater and more complex across regions, cultures and languages. The challenge is that data integrity must happen everywhere, both internally and externally. It’s common for regulatory authorities to give citations due to lack of data related to the outsourcing of processes.
Fragmented processes and systems: Data integrity requires a very clear audit trail that includes data about every communication and process. For example, if a company works with three partners in different countries to supply the same ingredient, data is typically communicated through email, file sharing technology and phone calls. If it’s determined that a finished product has a problem, it’s up to the quality team to uncover what happened. They must go back and check every activity across three outside organizations to determine when and where the root cause of the issue occurred. Data must be provided in chronological order, all the way down to the person that performed each individual task. On-premise and aging technology, group login capabilities, insecure emails and unrecorded events make it tough to easily identify and track all of the activities that led to an issue.
Changing role of quality: The quality team is critical to assuring data integrity and maintaining the quality, safety and efficacy of products from start to finish. Many companies still view quality as a cost center that stalls progress with time-consuming verification checks, instead of as an ally that gets drugs to market safely.
In Europe, a qualified person must also review all of the data, adding an extra layer of overhead and complexity. When quality oversight isn’t robust, important steps in data integrity processes can slip through the cracks. At the same time, quality is taking on more work. They must aggregate all data from each entity in the supply chain and provide quality metrics to the organization. Lack of visibility into early discrepancies can have significant impact downstream - resulting in drugs being destroyed, millions of dollars in losses and a damaged company reputation.
Potential for frequent inspections: As the FDA builds a formal program, poor data integrity could also be used to gauge risk that will drive frequency of future inspections. If data is not on par with what peers are providing, it could incent regulators to conduct more inspections at that site, further delaying progress as resources are diverted to support these extra cycles.
MODERNIZING QUALITY MANAGEMENT
While demands placed on life science companies seem overwhelming, there is a significant opportunity to leverage modern cloud technology, incorporate all partners into quality processes and gain end-to-end visibility across the supply chain. These three best practices can be taken now for a proactive and efficient approach towards data management:
- Modernize with the cloud: Cloud applications tailored for life sciences quality processes can extend data integrity across every part of the supply chain by capturing every data-driven event. Easily configured to work with existing business processes, the cloud ensures anyone who touches data - whether it’s uploaded, reviewed or accepted - is automatically documented.
- Incorporate partners into quality processes: Once implemented, cloud technology enables life sciences companies to bring together all partners on a single platform, collaborating in real-time and under controlled conditions, while automatically generating an audit trail that captures all activities. All parties interact and coordinate efforts using a common solution that provides a single source of truth into event status - accelerating processes. This also helps the quality group gain a better understanding of where possible issues exist so they can work with the supply base much more wisely. They can guide partners in other regions that may not be as knowledgeable on foreign regulations or improve compliance for problematic sites.
- Gain real-time visibility into the supply chain: Access to up-to-date, accurate data from the cloud provides greater transparency and confidence that processes across every partner are executed compliantly. A chronological record of performed activities - tracking every step made by suppliers - saves time and eliminates confusion on status. Quickly identifying process deviations allows the quality team to focus their time on reviewing investigation results and proactively addressing issues before they become bigger problems.
Karyopharm Therapeutics is an oncology biotech that is leveraging cloud technology to more effectively manage data integrity. The company focuses on the discovery, development and commercialization of first-in-class drugs related to the treatment of cancer and other major diseases. Soon after rolling out a cloud quality solution, Karyopharm was able to quickly improve quality processes with key partners. Top benefits included:
- Better efficiency for faster development. The most substantial benefit of moving to the cloud is increased operational efficiency by as much as 30 percent, due to streamlined processes and more efficient collaboration with partners. Because it’s easier to locate information, time spent searching for documents has been reduced from 20 minutes down to just two minutes. Regulatory filings has also accelerated, since all documents are easily located and linked directly into submissions.
- Improved quality control and greater compliance. Consolidating five different content-sharing channels into a single source of truth greatly improved productivity. Individuals that reviewed and accepted information to support the batch release process are now clearly identified, and there is a detailed and reliable audit trail readily available for inquiries from regulatory authorities.
- Real-time view for closer, more productive relationships. More scrutiny on foreign manufacturing sites by regulatory bodies has increased the amount of information exchanged between life sciences companies and partners for oversight. With clearer communication and more intelligent coordination in the cloud, Karyopharm has better alignment with partners.
“Modern cloud technology has dramatically improved our ability to align with key partners at all times throughout the manufacturing cycle,” said Maria Conklin, quality control manager at Karyopharm. “Along with improved collaboration comes the assurance that every communication and content exchange is automatically recorded in a detailed audit trial and backed with thorough documentation, in the event that anything is called into question by regulatory authorities.”
A NEW WAY TO MANAGE DATA
The cloud helps life sciences companies uncover and eliminate antiquated processes so that they can modernize the way they operate with a solution that adapts to fit their requirements. An expert from CPhl suggests that about 80 percent of data integrity issues are related to quality control processes and can be avoided. Leveraging the cloud has the potential to usher in new data management practices not previously considered because the technology is in line with the way companies work. Ultimately, this helps life sciences companies develop drugs safely and compliantly, so that new treatments can get to patients much faster.
ABOUT THE AUTHOR
Mike Jovanis is vice president of the Vault Quality Suite of products responsible for product strategy, customer engagement, and business development. He has more than 15 years of experience in life sciences, developing and designing quality solutions for organizations. Jovanis received his bachelor’s degree in marketing from Rutgers Business School and his MBA in Strategy and Global Business from Rutgers Graduate School of Management. For more information about Veeva Systems, visit www.veeva.com.