Kari Miller, QMS Regulatory and Product Management Leader, Global Tech Solutions, IQVIA07.12.22
Quality management is a complex process, and regulatory compliance can be even more difficult. So, life science companies find it challenging to implement strategies for both effectively across their entire enterprise. Connected compliance is the solution, but it’s practically impossible to achieve without appropriate tools.
Many companies turn to enterprise quality management systems (eQMS) that integrate quality processes and make regulatory compliance easier. With an eQMS, business leaders can guarantee that their quality processes and data are efficient and complete.
An intuitive user experience
Quality managers and regulatory professionals operate in a fast-paced environment where delays can have significant consequences. The system must be designed to surface information rapidly on demand to reduce pressure on workers and facilitate results.
Simple operability
An eQMS should be straightforward enough for casual users to operate, but powerful enough for administrators to produce personalized views and intelligent reports. Responsive interfaces and intuitive workflows must reduce the risk of operator errors and enable workers to make informed decisions quickly and effectively.
Convenient integration
Most life science companies already operate a full slate of applications, each aimed at achieving a specific goal. An effective eQMS must integrate easily and seamlessly with regulatory systems and others to avoid data duplication and ensure a single source of harmonized data. Additionally, to ensure data consistency and eliminate duplication of effort these integrations need to flow seamlessly in an end-to-end process that breaks down traditional departmental lines.
High-level reporting
The regulatory environment depends heavily on information, much of which requires the inclusion of data in real time. An eQMS must have continual access to complete, accurate quality data and be able to incorporate it into high-level summaries and reports and initiate appropriate impact assessments. Pre-built, standard analytics combined with robust quality and regulatory intelligence deliver immediate insights into process and product trends, enabling teams to make informed, guided decisions.
A connected compliance ecosystem (Safety, Regulatory and Quality) that delivers on each of these requirements can help life science companies systematize and streamline their quality, safety and regulatory processes including product registration practices to get products to market faster and keep them there through improved compliance throughout the connected compliance ecosystem.
Increased Productivity
By breaking down traditional silos, the integrated eQMS provides the necessary data to make informed decisions and implement changes rapidly. This increases productivity and reduces delays, while identifying and monitoring product and process deviations. With interactive dashboards, users can distinguish trends such as the timeframe for approval cycles, the trends surrounding product quality, and the duration of change requests, for just a few examples.
Reduced Risk
An eQMS with an integrated quality portal offers third-party clients and suppliers access to their quality information without compromising the core eQMS database. This minimizes the risk of damaging breaches and data losses, while the records management features provide streamlined processes to create, revise, and approve documentation without bottlenecks. A version control function lets users view and manage changes while supporting the “single source of truth” strategy. Electronic signature capabilities ensure signoffs are recorded while maintaining signoff compliance.
Improved CAPA Management
The management and verification of corrective and preventive actions (CAPAs) are vital in ensuring product safety and efficacy. A purpose-built integrated eQMS contributes to the success of this through the automatic creation of the CAPA regardless of the source of the event.
Additionally, the source and severity of the event should automatically adjust the workflow to ensure an effective CAPA with an action plan that is appropriate based on source and severity. When CAPA team members get timely, specific alerts, they can take immediate actions while preparing to execute planned actions to resolve problems and follow up on the results. This capability allows users to implement continuous improvement across the organization.
Faster Change Implementation
Executing changes without delay is critical to life science operations, so an appropriate eQMS must support automated and streamlined change management processes. From documenting required changes to moving them through impact assessment, review, approval, and implementation planning.
Impact assessments must include regulatory assessments as well. Using standardized workflows give regulatory professionals control of the process across the organization and allows for the inclusion of Safety, Regulatory and Quality disciplines within the organization. This collaborative, integrated approach provides faster results, greater transparency, and more accurate reporting.
Enhanced Insights and Analysis
The whole point of medical product compliance is to mitigate risk for patients. When an eQMS delivers enhanced insights and analytics, users can proactively manage quality and adherence to regulatory requirements and best practice standards. With a single source of truth, intelligent automation, and interactive dashboards, companies can obtain deeper, richer insights into the metrics that matter.
Other benefits of a purpose-built, integrated eQMS include centralized handling of quality issues and complaints, OOS lab result investigations, and simplified auditing. An eQMS using artificial intelligence can also learn from former iterations to develop accurate change plans and provide decision support.
As Regulatory and Product Management Leader for IQVIA Quality Compliance, Kari Miller is responsible for driving strategic product direction, and delivery of industry best practices and regulatory compliance solutions for quality management. She focuses specifically on translating market and industry requirements into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated Life Sciences market. She also is responsible for the Quality Compliance product roadmap, product partner relationships, and overall product direction. Miller earned a Bachelor of Science in Business Administration and a Bachelor of Science in Psychology from Marian College of Fond-du-lac, Wisconsin.
Many companies turn to enterprise quality management systems (eQMS) that integrate quality processes and make regulatory compliance easier. With an eQMS, business leaders can guarantee that their quality processes and data are efficient and complete.
Harmony Through eQMS
An eQMS is a digital platform developed for documenting processes and storing data in a reliable, secure, cloud-based environment. From there, stakeholders can readily access data with the reassurance that it is up-to-date and based on a single source of truth. For life science organizations, this functionality is vital to managing quality while maintaining the harmonized, connected compliance essential for meeting modern regulatory standards.Critical Prerequisites for a Life Science eQMS
Before implementing an eQMS, life science companies must assess their criteria for a system and ensure that the option they select delivers on all fronts. Some of the most important requirements of such a system include:An intuitive user experience
Quality managers and regulatory professionals operate in a fast-paced environment where delays can have significant consequences. The system must be designed to surface information rapidly on demand to reduce pressure on workers and facilitate results.
Simple operability
An eQMS should be straightforward enough for casual users to operate, but powerful enough for administrators to produce personalized views and intelligent reports. Responsive interfaces and intuitive workflows must reduce the risk of operator errors and enable workers to make informed decisions quickly and effectively.
Convenient integration
Most life science companies already operate a full slate of applications, each aimed at achieving a specific goal. An effective eQMS must integrate easily and seamlessly with regulatory systems and others to avoid data duplication and ensure a single source of harmonized data. Additionally, to ensure data consistency and eliminate duplication of effort these integrations need to flow seamlessly in an end-to-end process that breaks down traditional departmental lines.
High-level reporting
The regulatory environment depends heavily on information, much of which requires the inclusion of data in real time. An eQMS must have continual access to complete, accurate quality data and be able to incorporate it into high-level summaries and reports and initiate appropriate impact assessments. Pre-built, standard analytics combined with robust quality and regulatory intelligence deliver immediate insights into process and product trends, enabling teams to make informed, guided decisions.
A connected compliance ecosystem (Safety, Regulatory and Quality) that delivers on each of these requirements can help life science companies systematize and streamline their quality, safety and regulatory processes including product registration practices to get products to market faster and keep them there through improved compliance throughout the connected compliance ecosystem.
Benefits of a Purpose-Built integrated eQMS
For life science organizations to achieve a continual state of inspection readiness, they must meet the most rigid regulatory standards. An eQMS explicitly developed for the industry would offer significant advantages in this respect:Increased Productivity
By breaking down traditional silos, the integrated eQMS provides the necessary data to make informed decisions and implement changes rapidly. This increases productivity and reduces delays, while identifying and monitoring product and process deviations. With interactive dashboards, users can distinguish trends such as the timeframe for approval cycles, the trends surrounding product quality, and the duration of change requests, for just a few examples.
Reduced Risk
An eQMS with an integrated quality portal offers third-party clients and suppliers access to their quality information without compromising the core eQMS database. This minimizes the risk of damaging breaches and data losses, while the records management features provide streamlined processes to create, revise, and approve documentation without bottlenecks. A version control function lets users view and manage changes while supporting the “single source of truth” strategy. Electronic signature capabilities ensure signoffs are recorded while maintaining signoff compliance.
Improved CAPA Management
The management and verification of corrective and preventive actions (CAPAs) are vital in ensuring product safety and efficacy. A purpose-built integrated eQMS contributes to the success of this through the automatic creation of the CAPA regardless of the source of the event.
Additionally, the source and severity of the event should automatically adjust the workflow to ensure an effective CAPA with an action plan that is appropriate based on source and severity. When CAPA team members get timely, specific alerts, they can take immediate actions while preparing to execute planned actions to resolve problems and follow up on the results. This capability allows users to implement continuous improvement across the organization.
Faster Change Implementation
Executing changes without delay is critical to life science operations, so an appropriate eQMS must support automated and streamlined change management processes. From documenting required changes to moving them through impact assessment, review, approval, and implementation planning.
Impact assessments must include regulatory assessments as well. Using standardized workflows give regulatory professionals control of the process across the organization and allows for the inclusion of Safety, Regulatory and Quality disciplines within the organization. This collaborative, integrated approach provides faster results, greater transparency, and more accurate reporting.
Enhanced Insights and Analysis
The whole point of medical product compliance is to mitigate risk for patients. When an eQMS delivers enhanced insights and analytics, users can proactively manage quality and adherence to regulatory requirements and best practice standards. With a single source of truth, intelligent automation, and interactive dashboards, companies can obtain deeper, richer insights into the metrics that matter.
Other benefits of a purpose-built, integrated eQMS include centralized handling of quality issues and complaints, OOS lab result investigations, and simplified auditing. An eQMS using artificial intelligence can also learn from former iterations to develop accurate change plans and provide decision support.
How an Effective eQMS Enables Connected Compliance
The concept of connected compliance aims to go beyond optimizing a slate of incompatible systems. Instead, it embraces the ideal of intelligent automation that leverages data to apply updates to processes and determine their impact downstream. When a company deploys a purpose-built eQMS that checks all the right boxes, that vision becomes a reality. Life science companies adopting the connected compliance approach will need to look at the big picture and assess the entire Safety, Regulatory and Quality ecosystem ensuring that the vendor they choose can fully support the connected compliance vision of the future.As Regulatory and Product Management Leader for IQVIA Quality Compliance, Kari Miller is responsible for driving strategic product direction, and delivery of industry best practices and regulatory compliance solutions for quality management. She focuses specifically on translating market and industry requirements into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated Life Sciences market. She also is responsible for the Quality Compliance product roadmap, product partner relationships, and overall product direction. Miller earned a Bachelor of Science in Business Administration and a Bachelor of Science in Psychology from Marian College of Fond-du-lac, Wisconsin.