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Quality Assurance and Quality Control for Biotech Industries​

When it comes to long-term regulatory FDA and ISO compliance, explore effective strategies to optimize your quality management system. Learn more.

Quality Assurance and Quality Control

Did you know that the global biotech industry is expected to be worth more than $3 trillion by 2030? With a number like that, it isn’t surprising that biotechnology is gathering so much attention. With the ability to affect most areas of our lives, this could soon be the most important technology sector.

But in an arena as vast as biotechnology, how do you maintain quality? Projects require multiple professionals, often working in different locations, as well as advanced technology platforms, all working together. Read on to learn about the importance of quality assurance and quality control within the biotech industry.

What is the Biotech Industry?

Biotechnology concerns the use of living organisms to develop processes and healthcare products. Principles from molecular biology are used as well. Most of the major advancements in this industry have come in the form of medicine and other means for fighting disease. Some of the other areas that biotechnology impacts include:

  • Food production
  • Biofuels
  • Genomics

Biology isn’t the only science that this field relies on. It also uses concepts from mathematics, physics, and chemistry. Advanced technological applications like nanotechnology are also incorporated.

The Difference Between Quality Assurance and Quality Control

While they might sound like the same thing, quality assurance and quality control are different. Quality assurance includes all the steps that lead up to production. This is a verification that quality requirements are being met. It is a proactive process that aims to identify problems before they occur. It is systemic and focused on the creative process. 

On the other hand, quality control is actually a subset of quality assurance. Quality control typically encompasses multiple inspections throughout the production phase. This is to ensure that the end product meets safety and quality standards. These inspections could just be simple documented observations or full tests.

This is a reactive process that finds faults with the finished product. It focuses on different parts and is all about verification. 

Quality Assurance Processes​

Quality assurance is about prevention. It uses established processes that all personnel within the company are trained on. These processes include:

  • Documentation
  • Training
  • Audits
  • Investigations 
  • Supply chain management

Quality Control Procedures

Quality control is results-oriented. It uses procedures to identify faults in the finished product. These procedures include:

  • Batch inspection
  • Sampling 
  • Validation
  • Laboratory testing
  • Software testing

Quality Assurance and Control Personnel

The other major difference between these two quality realms is the personnel assigned to them. Quality assurance is more general and assigned to the whole team. From the time an individual is hired, some of their first days may include training in the quality assurance program.

As quality control is more specific, it has a dedicated personnel group. These individuals are trained in various forms of testing and can perform audits during and after the production process. Some large companies have entire departments dedicated to quality control.

Why Is Quality Assurance and Quality Control Important in Biotech?

Often, the products of the biotech industry are regulated by the U.S. Food and Drug Administration (FDA). The FDA has stringent requirements that require documentation at every step. This is required at every step, from conceptualization to the finished product.

Some of the major categories the FDA regulates include medical devices, vaccines, and cosmetics. The FDA has general regulations for all products that it oversees, but it even has specific regulations for items like animal studies.

This makes both quality control and assurance vital, not just in preventing errors but in meeting compliance. Both the processes of quality control and the testing of quality assurance must be documented. 

How Have These Processes Evolved?

Quality assurance and quality control have evolved with advances in technology. Prior methods of taking handwritten notes for documentation are inefficient and, in some cases, no longer meet current standards. Most large companies have moved into digital record-keeping. 

The advent of cloud-based data storage has helped. Using the cloud assists with quality assurance and control by automating data backups and security updates, as well as ensuring overall security.

What Solution Can Help You Meet Compliance?

Within the biotech industry, there are many start-ups and smaller companies that lack the funding for compliance departments or dedicated personnel. The Compliance Builder makes data management more practical by allowing you to control signature and electronic document compliance across all IT systems.

Through automated record-keeping, this product creates an audit trail that makes it easy to track changes. It also includes multiple security features, such as:

  • User access control
  • Data security
  • Centralized data archive

This product includes other features that enhance quality assurance and control, such as tracking version history, a dashboard feature, and email notifications. The Compliance Builder program comes in multiple models to fit either a single system or an entire network. It works across multiple database versions, operating systems, and browsers.

Are You Ready for Your Quality to Go to the Next Level?

Now that you know about quality assurance and quality control, what are you waiting for? While these terms sound similar, they are different. Understanding those differences is important to maintaining a good quality program.

The biotech industry is heavily regulated, and appropriate document control is essential. The old ways of using notebooks and file cabinets are no longer effective. There are emerging technologies that are affordable, scalable, and reduce the need for dedicated quality personnel or departments. Xybion provides a real-time compliance monitoring software specifically designed to help companies pass audits and achieve 21 CFR Part 11 compliance.

If you’re ready to learn more about quality assurance and control or to get started on your path to compliance, book a demo of Compliance Builder. This will help you prepare the most reliable and trustworthy records that will withstand regulatory inspections.


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