GxP Lifeline

The Secret to Clinical Manufacturing Success: Integrate Quality Early


All life sciences manufacturers face a host of pressures, stringent regulations, and potential pitfalls. In the clinical manufacturing sector, these challenges are intensified to an even greater level of complexity. Manufacturing materials and supplies for clinical trials involves smaller batches and greater variables, which heightens the complexity of production efforts and the precision that is required to carry out processes.

There are three significant challenges clinical manufacturing entities face that aren’t typically constraints for most commercial life sciences manufacturers:

  1. Processes and products evolve with greater velocity.
  2. Testing processes and specifications are more prone to change.
  3. Dealing with a broader range of high-mix/low-volume production lines inherently involves a much greater degree of intricacy.

These challenges are only compounded when paper-based processes are used. Manufacturers of clinical products who can successfully manage these challenges on an ongoing basis share two commonalities:

  1. They have digitized and integrated quality into manufacturing activities as early in the process as possible.
  2. They are able to consistently maintain connected quality throughout the life cycle of their products.

The intersection of quality and manufacturing through digitization is so pivotal to success in clinical manufacturing that it was identified in MasterControl’s latest industry brief as one of four critical capabilities that manufacturers must master to stay competitive in the field.

Why Early Quality Integration is Critical

Rapid, continual change is the hallmark of clinical manufacturing environments. The persistence of change means that clinical manufacturers must be more agile and operationally adaptable than most companies that manufacture regulated products, as noted above. But a greater need for flexibility places heavier demands on an organization’s quality function. It requires quality teams to be nimble when situations demand it without sacrificing their ability to enforce the appropriate controls when they are required.

In clinical manufacturing, a quality department’s enforcement of good manufacturing practices (GMPs), which were devised with large-scale commercial operations in mind, must be selectively tailored to meet individual circumstances. As a result, clinical manufacturers need systems that allow them to make many changes quickly — and often systemwide — with the least amount of effort and friction.

Disconnects between manufacturing and quality are nothing new in manufacturing environments. Even so, the lack of data connectivity poses major obstacles across life sciences industries and is hitting the velocity-focused world of clinical manufacturing particularly hard. Industry analysis firm LNS Research noted the problem in a survey of manufacturing operations managers of life sciences companies.

More than 20% of survey respondents identified the following issues as the two main obstacles to meeting manufacturing objectives:

  1. Timely visibility into manufacturing performance metrics.
  2. Disparate systems and data sources. (1)

The pervasiveness of these issues makes it clear that clinical manufacturers who delay digitization will continue to struggle. Organizations that choose not to integrate quality and manufacturing processes do so at their own peril.

Clinical Activities Head to the Cloud

As digitization enables more clinical efforts to be spread across different locations, cloud technologies are proving to be invaluable tools. Cloud-based platforms have become indispensable frameworks that enable companies to overcome common clinical pitfalls and unite their efforts within a shared architecture. Advancing the use of web-based technologies in clinical activities is essential to the industry’s progress, according to Stephen Mayo, founder and CEO of the clinical research organization (CRO) Emissary International.

“The completely paperless clinical trial could soon become a reality,” Mayo said. “The lesson: Use the web to help make the clinical trial process faster, cheaper, and more efficient.”(2)

Implementing an integrated cloud platform to digitally connect production with quality enables clinical manufacturers to overcome conventional challenges and can bring substantial benefits such as:

  • Dramatic improvement in right-first-time (RFT) metrics.
  • Maximized productivity on the shop floor.
  • Directly embedding quality into manufacturing processes from initial stages and throughout the entire product life cycle.

Top 10 Advantages of Platform Integration

Stephanie Kuhn, senior director of quality assurance at leading contract development manufacturing organization (CDMO) Ology Bioservices, has seen firsthand the advantages of uniting quality and manufacturing processes and data. At the 2020 Virtual Masters Summit, she shared her top 10 list of benefits companies can attain by harmonizing manufacturing and quality efforts within a single cloud-based platform as her organization has. According to Kuhn, platform integration enables a company to:

  1. Maintain business continuity with a remotely accessible infrastructure.
  2. Save time by consolidating systems (and, in Ology’s case, with the system’s built-in templates).
  3. Give authorized users convenient access to systems, records, and data from wherever they are located.
  4. Save money.
  5. Ensure quality assurance (QA) compliance.
  6. Maintain data integrity.
  7. Condense training.
  8. Enhance adaptability and more readily adopt the risk-based approach favored by regulators.
  9. Augment manufacturing flexibility with electronic batch records, templates, and integrated processes.
  10. Effortlessly interface with clients. (3)

Learn More About Clinical Manufacturing Trends

Early integration of quality within a shared platform is just one piece of the clinical manufacturing puzzle. For more insights that can help your company accelerate clinical manufacturing processes, check out the “Mastering 4 Critical Capabilities in Clinical Manufacturing” industry brief.


  1. A Road Map for Addressing Quality and Manufacturing Challenges in Life Sciences: Moving Beyond Regulatory Burdens to Enable New Collaborative Models for Growth,” Matthew Littlefield, Rob Harrison, et al., LNS Research.
  2. Avoiding the Five Common Pitfalls of Clinical Trials,” Steven Mayo, MDDI, Nov. 2002.
  3. “Top 10 Benefits of a Connected Cloud-Based Platform,” Stephanie Kuhn, Virtual Masters Summit presentation, Oct. 20, 2020.


James Jardine is a marketing content writer at MasterControl, Inc., a leading provider of cloud-based quality and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.

Free Resource
Mastering 4 Critical Capabilities in Clinical Manufacturing

Enjoying this blog? Learn More.

Mastering 4 Critical Capabilities in Clinical Manufacturing

Download Now
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]