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How a Purpose-Built eQMS Improves Compliance in Life Science Organizations

A lack of integration hampers quality compliance across a product’s life cycle

Published: Thursday, May 4, 2023 - 12:03

Life science organizations depend on quality management systems (QMS) to improve products, minimize risks, ensure patient safety, and support regulatory compliance. When companies use a horizontal QMS that is not purpose-built for the life science industry, they must execute additional steps to integrate it with other applications. This lack of integration hampers quality compliance across a product’s life cycle, leaving companies vulnerable to rapidly shifting regulations and frequently changing requirements. However, by deploying a purpose-built eQMS, business leaders can access multiple benefits for their organizations.

How nonintegrated applications hinder quality  

Breaking down silos is critical to enabling life science organizations to operate more effectively and comply with regulatory requirements. Silos remain a common challenge, particularly in large enterprise organizations, and nonintegrated applications only serve to sustain them. Silos cause failures in cross-team communication, limit productivity, and block the free flow of information. This is contrary to the end-to-end, closed-loop approach necessary for harmonization and compliance.

Benefits of a purpose-built eQMS for life sciences 

Most life science companies already operate a wide range of applications, each aimed at achieving a specific goal. With an eQMS designed explicitly for their needs, organizations in this highly regulated industry can integrate easily and seamlessly with other systems. An eQMS should already integrate all the components of a quality management system, in addition to being easily integrated with other applications.

A unified, multi-tenant, cloud-based eQMS offers the following benefits for users:

Prevents data duplication

Data duplication can be a massive problem for any company, causing inaccurate reports and analysis, inconsistencies, and challenges with data observability, security, and privacy. With an integrated, purpose-built eQMS, organizations can create a single repository for all their data instead of having several versions used across various company silos.

Delivers data harmonization

Data harmonization combines data from multiple sources to provide users with a comparable view of all the information gathered. This process increases the utilization and value of the data, enabling organizations to correct inaccuracies and incorporate data fragments into usable insights.

Ensures data consistency

The quality and “usability” of data are critical for the practical usage of insights in life sciences, relying heavily on consistency. As one of 10 data quality dimensions, consistency requirements are met when two or more values in different locations are identical. The best way to achieve this is to ensure all data accessed come from a single source of truth that does not depend on individual updates. When data are synchronized flawlessly, a clinician accessing information on issues such as a drug-related adverse event uses the same information other clinicians have used—not merely a copy of it.

Minimizes labor requirements

Using an eQMS that operates across traditional silos requires manual data integration to enable users to get the insights they need. This labor-intensive process can involve many hours of checking, copying datasets, uploading them to compatible programs, merging, and revisiting them to eliminate duplicates. The process is fraught with the potential for human error and can incur high labor costs for companies. With a purpose-built eQMS tailored for the life science industry, data flow swiftly across departmental lines in a seamless, end-to-end process.

If the nonconformance model is not integrated into the CAPA model, nonconformance data must be reentered when it is transferred to the CAPA model. Integrating the nonconformance and CAPA models automatically copies the data between systems, removing the need for data reentry as well as the opportunity for human error upon reentry. A purpose-built eQMS can also integrate with other systems, such as clinical, to further reduce data reentry across enterprise operations and systems.

Raises productivity levels

Once traditional silos break down and eQMS integration delivers cross-functional insights, executives can make and implement informed decisions more rapidly. This capability raises productivity levels by enabling users to identify trends around approval cycles, product quality, and the time frame for approval cycles and change requests. With this knowledge, companies can adjust their operations to optimize production.

Reduces production delays

Accessing insights earlier allows companies to act faster, resulting in shorter production time frames and fewer delays. Lower risk of human error across datasets and silos also helps eradicate production problems, allowing for better cost efficiencies and quicker turnaround times. By deploying an eQMS purpose-built for life sciences, companies can ensure they comply with all regulatory requirements and avoid holdups and production delays.

Protects data security

In most industries, company data is shared with third-party clients and suppliers—all of whom can introduce cybersecurity risks to the database. A purpose-built eQMS designed for the industry provides secure, streamlined processes for creating, revising, and approving documentation for internal parties and via a secure portal for third-party participants. Thus, the risk of a data breach is lowered. Version control allows users to view and manage changes without detriment to the single source of truth. Additionally, electronic signoffs are recorded, and all transactional data flow into an audit trail.

Delivers superior reports

Access to information in real time is a mainstay of patient safety, so any QMS deployed in the life sciences environment needs to deliver convenient summaries, reports, and impact assessments. With a purpose-built solution, enhanced insights and analytics provide users with rich insights into metrics that matter.

Centralized issue management

An integrated eQMS designed for the life science industry provides centralized handling of quality issues and complaints, OOS lab result investigations, and simplified auditing. This streamlines users’ operation of the platform, which helps support patients experiencing complications or adverse events. It also minimizes resources needed to coordinate these activities, resulting in further time and cost savings.

A positive result 

With U.S. national healthcare spending projected to reach $6.2 trillion by 2028, all cost-saving initiatives deserve recognition. A purpose-built eQMS represents multiple ways to improve results while lowering the overall cost of quality and compliance, including benefits ranging from increased productivity to reduced labor costs, fewer production delays, better reporting, and enhanced cybersecurity. That’s a positive result by anyone’s calculation.


About The Author

Kari Miller’s picture

Kari Miller

As regulatory and product management leader for IQVIA Quality Compliance, Kari Miller is responsible for driving strategic product direction and delivering 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 road map, product partner relationships, and overall product direction. Miller earned bachelor’s degrees in business administration and psychology from Marian College, Fond du Lac, Wisconsin.