Why Is Technology the Answer to Process Validation Problems That Many Companies Face?

Process validation plays an important role in creating reliable and accountable systems throughout the entire pharmaceutical industry supply chain. The FDA is heavily focused on ensuring that the quality of a product is consistent every time.

Manufacturers in the pharmaceutical industry know how challenging it is to guarantee the same level of quality across multiple companies, manufacturing facilities, and when delivering their products to the next stage in the supply chain. 

Process validation systems are designed to increase transparency and accountability by documenting the exact steps that occur in any given process. These systems often include PLCs, HMIs, control systems, and more.

Many companies are now relying on sophisticated software to streamline process validation. While adopting these systems requires process validation training, the benefits they offer over traditional methods can decrease violations and improve your overall compliance systems. These modern systems guarantee quality control, expedite cataloging, and entering products into databases, logging changes that occur, labeling, and overall process control.

What Are The Advantages?

• Enhanced documentation and transparency for compliance. Everything a drug manufacturer does must be documented and traceable. Technology allows a company to maintain streamlined records that are accessible, compliant with current CGMPs and other manufacturing requirements, and that all written documentation highlights quality control, anomalies, and other changes.
• Track and validate the entire lifecycle of a product. The manufacturing process is complex and contains many steps. Specialized software is better able to handle complex validation tasks that involve many inputs and a large amount of data. You can isolate specific instances where a deviation occurred and perform the necessary steps to ensure that a change is compliant with current regulations.
• Automate time-consuming tasks. There are many processes that a drug manufacturer needs to consider, validate, and ensure compliance for. Manually screening each of these steps is time-consuming and will increase your overhead. Process validation technology can automate many of these tedious tasks to provide enhanced accuracy and clarity.

Improve Your Systems With Our Process Validation Training

Is your company looking to improve the way it approaches process validation? Our Process Validation for Drugs and Biologics course will teach you process validation best practices, how to create a compliant system, and other strategies you can use to increase your operational efficiency.

Please contact the Center for Professional Innovation and Education (CfPIE) at 1-610-648-7550 or visit Cfpie if you’re interested in learning more about our pharmaceutical training courses.