The industry has accepted that Validation is a mandatory requirement. Yet, we still hear from delegates at various conferences, that the process puts a significant strain on their resources. To a certain extent, I agree.
The purpose of Validation, first and foremost, is to ensure patient safety, product quality and data integrity. However, just like another business function, Validation when managed ineffectively and in isolation will become a significant drain on functional resources. It is by failing to understand the system requirements from the onset that result in inefficiencies.
Having Validation involved earlier in the development process will help them better understand the end goals of a system. Embracing a Quality Risk Based Approach however, will help to shrink costs and counter out such negative opinions.
Adopting a Risk Based Approach allows for efficient processes, and is an effective way to optimise business, operational and regulatory risks. It provides a structured approach to validations efforts to those areas that pose the most risk.
GAMP 5 and Quality Risk Based Approach
GAMP 5 provides a source of guidance. These guidelines (not standards) allow for the development of processes and reduce control in areas that affect GxP compliance, allowing for more efficiency which will help to shrink costs. The guideline further promotes cross functional engagement involving key users, analysts, system developers, integration experts CSV specialists, co-coordinators and suppliers which is a sound approach. Each function must work together to achieve desired results. It is this focus that had our team shouting “AT LAST”!
It’s nothing new
This approach is not new to Empowerment QE, with our background residing in Software Engineering we have designed, built and tested some of the world’s most complex software in the Telecoms, Financial and Automotive industry. Through cross pollinating such industries best practices with our knowledge of "agile" software development processes, we successfully delivered optimum results that exceed GAMP expectations and that of our clients, driving real resource savings.
We achieved Right First Time Validation many years ago on our first engagement in the Life Sciences by adopting such an approach, moreover, as auditors we did so remaining fully compliant. EmpowermentQE have continued to do so ever since! We can help your validation team fully embrace an Holistic Quality Risk Based Approach.
- Fully engage with the concept of Quality Risk Based Validation. With a strong background in software engineering and compliance EmpowermentQE can guarantee that the verification and validation activities fully complement each other. This will result in reduced time lines and reduced project costs.
- Provide a holistic approach ensuring that the engineering, IT, quality, production and validation departments are aligned so that they work towards the same end goal and same quality standards. This will allow for maximum efficiency.
- Provide expertise to perform such roles within the GAMP5 category 4 and 5 computerised system projects. Applying GxP to the IT environment.
- Provide training on software engineering QA and Test practices that provide immediate value add for the validation team, ensuring adherence to FDA and EMA guidelines, and GxP.
View EmpowermentQE website find out more about a quality risk based approach.