Large projects
We have the capacity and experience to manage large-scale projects at international level, taking full responsibility of the areas of automation, qualification and CSV validation in comprehensive projects for new pharmaceutical or biotechnology plants.
International team
We have technicians of various nationalities and we are used to carrying out projects in any country, seeking in each case the optimal combination of on-site and remote work.
Mastery of the GMP environment
With more than two decades of experience in GMP environments, our technical team has in-depth knowledge of the applicable regulations and extensive experience working efficiently under strict GMP guidelines, complying with CFR21 part 11 and EU Annex 11 following GaMP 5, ISA88, ISA101 guidelines.
Versatility and adaptability
We adapt to the standards and ways of working of our clients. We can execute projects of any size, from small refurbishments to large comprehensive projects.
DCS architectures
We have extensive experience in various DCS platforms, carrying out projects with different versions of each system and with very diverse implementations, often communicating hardware from various manufacturers.
PLC+HMI+SCADA architectures
We are experts in providing solutions for GMP environments from leading automation manufacturers and have developed a large number of projects with these technologies.
Validation and qualification of computerised systems
We carry out the validation and/or qualification of your control systems, irrespective of the brand and who has programmed them. If necessary, we can define and implement the necessary improvements.
Complete CSV cycle
Comprehensive management of the complete CSV validation cycle, including risk analysis, documentation and design review, definition and drafting of necessary protocols and execution of the same, with handover to production or quality assurance.
Project management
We take care of project coordination, from cost estimation to contacting suppliers. After carrying out preliminary analyses, we study the feasibility of the project and coordinate its execution. Finally, we carry out the commissioning and we offer on-site operational support to our clients.
Process design
We carry out industrial scaling, design and sizing of equipment and facilities, including the development of P&IDs and risk analysis.
Execution
We carry out commissioning as well as installation and operational qualification.
GMP experts
We design equipment with sanitary design, clean utilities, SIP/CIP systems and also write validation protocols and investigate deviations.
IT systems administration
We have a team experienced in the administration of IT systems in GMP environments, including definition and configuration of industrial networks, installation and maintenance of servers and virtual machines, and configuration of backups.
Data historization and analysis systems
We design, programme and configure data storage and analysis systems, such as Aveva PI, FT Historian, etc., creating solid architectures adapted to the specific needs of our clients.
