Today’s testing laboratories face the challenge of meeting increasingly complex regulatory requirements. At the same time, they need to keep up with the rapid development of technology. Therefore, the implementation and validation of computerized systems is becoming an indispensable part of their operations – especially for laboratories operating under international regulations and subject to audits.
To meet these requirements, laboratories are using recognized guides to support operations in regulated environments. One of the most important of these is GAMP5, whose update, GAMP5 v2, includes a number of changes affecting the daily practice of laboratories.
What is GAMP5 v2?
GAMP5 v2 (Good Automated Manufacturing Practice Guide for Validation of Automated Systems in GxP Environments) is an updated version of the acclaimed guide developed by ISPE. This document provides best practices and guidelines for the validation and qualification of automated systems used in regulated environments – among others. pharmaceutical, biotechnology and laboratory.
While GAMP is not a formal standard or norm, it is a globally recognized source of knowledge. Moreover, it supports meeting requirements such as EU Annex 11, 21 CFR Part 11 and GxP guidelines.
The GAMP5 v2 version does not introduce a revolution, but develops and updates approaches known from the first edition. It places more emphasis on risk analysis, critical thinking and flexible working methods such as Agile and DevOps. In addition, it emphasizes the importance of cooperation between the end user and the system provider – with clearly defined roles and responsibilities.
GAMP5 v2 highlights
- Risk management – an extension of the approach to identifying, assessing and minimizing risks associated with the operation of IT systems.
- Data governance – increased focus on data integrity and security, in the context of compliance with regulations such as RODO.
- Cutting-edge technologies – including innovative solutions such as artificial intelligence (AI), machine learning (ML) and blockchain to support the automation of laboratory processes.
- Validation flexibility – adaptation of the Agile approach to validation processes, enabling faster and more iterative adaptation to changes.
The importance of validation and automation of laboratory processes
For laboratories with high regulatory requirements, the implementation of automation and validation of computerized systems is a key element in supporting their operations.
The benefits of automation and validation include:
- Data reliability – precise validation ensures data compliance with audit and regulatory requirements.
- Process optimization – automation eliminates time-consuming manual operations, improving work efficiency.
- Minimizing errors – reducing human errors translates into better quality results and safer operations.
Hakon Software – your partner in validation, security and automation
Hakon Software has been supporting research laboratories in Central and Eastern Europe for years. We provide comprehensive IT solutions that comply with PCA, GMP and FDA regulatory requirements. We specialize in the automation of laboratory processes and validation of IT systems aligned with the latest guidelines.
Our services include:
- IT security and business continuity – ensuring that laboratory systems are protected from cyber threats and guaranteeing uninterrupted access to key resources and processes.
- IT systems valid ation – comprehensive validation support to help laboratories safely pass audits and inspections.
- Process automation – implementing technologies that allow for data management, performance analysis and reporting.
- LIMS NG system – implementation of a state-of-the-art laboratory data management system that improves data integrity, increases efficiency and facilitates regulatory compliance.
Summary
Investing in solutions that comply with the GAMP5 v2 guide is not just a regulatory necessity. It is also a real opportunity to optimize and modernize the work of laboratories. Collaboration with Hakon Software enables the company to meet PCA, GMP and FDA requirements, while ensuring increased operational efficiency. Our experience in the laboratory sector makes us a trusted partner on the road to process excellence.
If your lab needs validation, automation or IT security support, contact us!
📧 Email: info@hakon.pl
📞 Phone: +48 600 601 165
