How Should Life Sciences Organizations Modernize Their Compliance and Quality Management?

At a recent intro summary Sikich “Maneuvering the Milestones” event, Mickey Huber, Director of QMS Solutions, and Sid Shankar, QMS Delivery Lead for our regulatory quality and compliance practice, discussed key trends in the life sciences industry’s quality management systems (QMS) and processes. Here are some highlights of their insights and recommendations.

Silos make way for agile data management

In QMS, rigid data silos are quickly giving way to a more holistic way of managing information and processes. More and more, organizations see the value in unlimited visibility of the business and its product lifecycles from ideation to commercialization.

While information silos are still relatively common, for example, in the quality supply chain R&D of life sciences organizations, the trend is for needless and unproductive barriers to be swept away as companies adopt comprehensive, connected business management systems.

Quality management systems are enveloped by this drive to unfettered data flows, and therefore, can leverage the increased agility that becomes possible with them. For some older and larger organizations, that may mean reimagining the value of QMS. In their conversation, Huber and Shankar describe an approach that strikes healthy balance between compliance, quality, and transparency, embedded within an organization’s culture of “quality.”

The building blocks of modern quality management

Even fledgling life sciences organizations still far from commercialization should start their quality and compliance journey with a QMS that can support change management, risk analysis and management, failure mode and effects analysis (FMEA), corrective and preventive actions (CAPA) management, and end-to-end handling of quality incidents.

Long before companies commercialize a product, and during the entire process, such disciplines as change control, deviation management, document control, and CAPA are essential for maintaining regulatory compliance. Many modern QMS solutions provide these capabilities in a standardized, turnkey manner. Sikich QMS experts can help finetune them to specific requirements for your needs.

We often work with life sciences organizations to assist in designing IT validation and compliance practices, satisfying regulatory mandates by the U.S. Food and Drug Administration (FDA), the European Union (EU), and other entities. In these collaborations, Sikich practices step-by-step verification to ensure trusted audit trails, change controls, user authorizations, and other subsequent, best practice manufacturing (GMP) criteria are adhered to.

Sikich also enables clients to realize greater business value with compliance by configuring QMS’ and optimizing processes to follow the industry’s best-practice guidance in accordance with regulatory standards.

In addition, Sikich provides consistency for users to leverage their organization’s apps and mobile devices to interact smoothly with the QMS. Technology users in many life sciences organizations access and manage documents using mobile software as the de-facto medical device. These companies should pay close mind and extend quality management efforts to incorporate these specific use cases.

AI innovation comes to quality and compliance management

Most Sikich life sciences clients realize benefits by modernizing their legacy QMS with solutions that draw on newer technologies such as AI. This enables earlier and wider visibility, improving product and process quality without necessarily increasing costs. It can be challenging to take full advantage of AI opportunities and maintain compliance with stringent regulatory frameworks like General Data Protection Regulation (GDPR) in Europe, which also applies to U.S. companies that have customers or business activities in European countries.

Sikich expert consultants know how to help companies achieve compliance and maintain appropriate data protection protocols while they benefit from trend analysis, natural language processing, and other capabilities that AI makes possible.

As many life sciences companies incorporate a greater variety of data sources, including edge medical devices or software systems like ERP in a unified technology environment, it only makes sense to also expand the use of AI to make sense of all that data.

In creating this connected digital platform, expertise can make a big difference in enabling the visibility and proactive agility companies look for, while keeping technologies simple and manageable. When Sikich consultants work with life sciences clients, they find ways to deliver these benefits for their user community as they maintain the efficiency and adhere to the stringency of compliance and data protection measures.

A nuanced approach to meeting CSA guidelines

Event participants shared concerns about the impact of the FDA’s updated Computer Software Assurance (CSA) guidelines on quality compliance management by life sciences companies.

Huber and Shankar recommended an all-encompassing, risk-based approach that entails elements of cybersecurity, reliability, and privacy of connected systems and infrastructures.

They also pointed out that the latest version of CSA guidance could encourage organizations to reconsider applicable risks. Generally, life sciences companies have considered their QMS and quality management practices in a direct relationship to patient safety, which mean they require a consistently high-level of validation.

However, that may not always be necessary or even helpful, and a nuanced strategy may be more effective. For instance, if medical device software fails, patients may immediately be at risk, and life sciences companies need to implement the appropriate level of control.

On the other hand, if a module in the QMS malfunctions and the processing of a record is delayed by a few days, that event may not be a significant risk contributor. It may make more sense for organizations to consider the broad variety of situations CSA addresses, and then adjust their QMS and processes appropriately, with complete documentation of their steps. Sikich life sciences consultants often help our clients avoid unnecessary controls while maintaining end-to-end, uncompromised quality management.

Here to help

Sikich is proud of many long-standing relationships with life sciences clients. We provide solutions for NetSuite, TrackWise and others, optimized for industry requirements while delivering a broad portfolio of services from everyday support and technology management, to cybersecurity and strategic consulting.

To explore how engaging with Sikich could help your life sciences organization, you can:

This publication contains general information only and Sikich is not, by means of this publication, rendering accounting, business, financial, investment, legal, tax, or any other professional advice or services. This publication is not a substitute for such professional advice or services, nor should you use it as a basis for any decision, action or omission that may affect you or your business. Before making any decision, taking any action or omitting an action that may affect you or your business, you should consult a qualified professional advisor. In addition, this publication may contain certain content generated by an artificial intelligence (AI) language model. You acknowledge that Sikich shall not be responsible for any loss sustained by you or any person who relies on this publication.

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