The pharmaceutical and biotechnology industry in Spain is going through a crucial phase marked by digital transformation, regulatory evolution, and the need to guarantee data quality and safety at all times.
In this context, many companies in the sector face a key question: Are our computer systems aligned with the most demanding regulatory standards? In this article, we aim to guide you through this reflection.
First requirement: Computerized system validation
Computerized system validation is a requirement that companies in the sector must complete to comply with applicable regulations and maintain necessary authorizations and certifications.
But what is computerized system validation?
It is the review process to which a computer system is subjected to verify that it meets all its specifications and is capable of carrying out its purpose in compliance with applicable regulations and the expected use by the regulated user. However, it is not limited solely to applications or programs. It also applies to hardware operation and real-time integration of mobile devices, among others.
The validation of a computerized system consists of two elements:
As a general rule, any computerized system that impacts drug or medical device production activities—and could therefore affect final product quality, patient safety, and generated data integrity—must be validated.
System validation affects activities described within the following concepts:
Not all computer systems require validation. However, validation gains great relevance in other applications, among which we can highlight:
Regulatory compliance: An increasingly complex task
Compliance with GxP regulations (GMP, GCP, GLP, GDP, GVP) is an ongoing responsibility. However, keeping computer system validations updated and ensuring that processes adapt to regulatory and technological changes can be a real challenge:
The result: unnecessary risks, inefficient processes, and a growing exposure to non-compliance that can affect both business reputation and operations.
The solution: PRaaS, periodic reviews that guarantee continuous compliance
To address these challenges, Ambit Iberia has develope PRaaS (Periodic Review as a Service), a service specialized in the periodic review of computer systems in regulated environments. This service is designed specifically for the life sciences industry, with the goal of:
✅ Ensuring continuous compliance with GxP regulations (GMP, GCP, GLP, GDP, and GVP).
✅ Reducing non-compliance risks through a preventive approach.
✅ Optimizing resources by outsourcing a critical and highly specialized function.
✅ Improving the quality of validation processes without overloading internal teams.
Furthermore, PRaaS allows maintaining a clear and updated view of system validation status, facilitating decision-making and alignment with industry best practices.
Do you want to avoid surprises in your next audit?
Discover how PRaaS can help you guarantee the continuous quality, security, and compliance of your computer systems. Click here for more information about PRaaS by Ambit Iberia.
En Ambit Iberia we have been experts for over 20 years in developing IT strategies and solutions. We help the pharmaceutical, medical device and IVD (in vitro diagnosis) medical device sectors comply with regulations throughout the product lifecycle. We design and implement innovative infrastructures thanks to a comprehensive service offering acting as a key enabler for digital transformation.