Transitioning to Digital GAMP® 5 Validation

Written by: Hanna Taller

Read Time: 2 min

Computer-based systems validation in a regulated industry is no walk in the park. So, it's no surprise that the pharmaceutical industry is still slow to innovate when it comes to manufacturing processes and operational speed. To create a computer-based system that serves its purpose in a reliable, transparent, and most importantly safe way, companies developing pharmaceutical products need to meet various predefined requirements. To protect the end-users, quality, and safety must take priority. This is where GAMP comes into the picture.

What is GAMP® 5? 

In a nutshell, GAMP represents a structured approach to validating computer systems in digital pharmaceutical products. GAMP® 5 second edition is the latest standard of the guideline; it was released in July 2022 by the International Society for Pharmaceutical Engineering (ISPE).

It is important to note that rather than being a regulation, GAMP® 5 is a set of principles and procedures created to help validate automated computer systems for manufactured pharmaceutical products. In simpler terms, this guideline assists manufacturers in meeting the necessary regulations to bring their products to market. These industry best practices are widely acknowledged and adopted by regulated companies and their suppliers worldwide.

Pharma process validation 

Traditionally, process validation in pharma has been paper-based and slow to innovate. This means that pharma project managers must manually validate computerized manufacturing automation and process control systems. Doing process validation on paper can involve managing thousands of pages of documentation by hand. This dependency on paper-based processes creates challenges for organizations that want to modernize their manufacturing processes and improve the speed and efficiency at which they go to market. 

If you want to stay ahead of the curve you need to make the transition to digital process validation. If your goal is to bring life-changing products to market faster and more efficiently you have a real opportunity to do so by digitally transforming your manufacturing process, such as digitalizing pharma quality management processes and collaboration.

Benefits of digital pharma process validation 

Gradually digitalizing phases of process validation in pharma provides numerous benefits. Companies will be able to troubleshoot production problems more efficiently, and correct errors faster and more efficiently. Digital pharma process validation also equips companies to quickly process data about products that are already on the market in order to improve them.

The main advantages of digital pharma process validation: 

  1. Reduced time to market 
    You can go to market faster with your product much faster, due to less delays and disruptions 

  2. Agility and flexibility 
    With operational excellence, better collaboration across teams, and higher levels of data integrity, it is easier to quickly adjust products and improve them based on feedback
  3. Ensured quality and compliance 
    Creating high-quality products and ensuring compliance with regulations like GAMP® 5 becomes much more straightforward, due to improved data integrity, traceability and consistency
  4. Improved scalability 
    Faster process validation with quick iterations based on feedback leads to a better final product, plus a shortened time to get to market means you can produce more at scale

Using Codebeamer’s predefined Pharma GAMP® 5 Template can help you expedite the validation process and make going to market a thorough and rewarding process. Codebeamer’s Pharma GAMP® 5 Template was developed in collaboration with pharmaceutical automation experts and is designed to help pharma companies, suppliers, and system integrators achieve compliance smoothly and easily. 

Learn more about Codebeamer's Pharma GAMP® 5 Template!

Adhere to GAMP guidelines to maintain focus on patient safety, product quality, and data integrity across the pharma product innovation lifecycle. Get the Template
Tags: Application Lifecycle Management (ALM) Codebeamer Life Sciences

About the Author

Hanna Taller

Hanna Taller is a content creator for PTC’s ALM Marketing team. She is responsible for increasing brand awareness and driving thought leadership for Codebeamer. Hanna is passionate about creating insightful content centered around ALM, life sciences, automotive technology, and avionics.