Software & systems in the Pharma & biotech field
Unlike in the past, most infrastructure, manufacturing and packaging systems, Track & Trace systems, testing equipment and laboratory equipment used in pharma and biotech, are connected/managed / controlled/controlled / operated using the software.
Besides, central and local control and monitoring systems used in factories, production departments and laboratories, based on software or at least contain software components. Many pharmaceutical manufacturing establishments in the world have even undergone complete computerization/digitization of production processes and therefore, the domain of integrity and reliability of the data obtained from the software used, both at the pharmaceutical product level and as part of the support processes, despite the huge contribution to progress, also carries many risks And for critical process parameters, there is an impact on product quality and safety and, as a result, on the health of the consumer/patient.
Software & systems consulting services in the pharma & biotech field
Verification & Validation for software and control systems
CSV and 21CFR part 11 employee trainings
HIPAA and GDPR risk assessments
ISO 27001 and ISO 27799 certification
ISO 14001 certification
Track & Trace projects
ERP system purchasing and validation
Preparation towards external regulatory audits
Quality management and GMP systems establishment
Master documents, policies and procedures writing
Back up, restore and disaster recovery procedures
Compliance with 21CFR part 11 requirements
- Compliance with Annex 11 requirements
Compliance with GDPR, PHI, HIPAA, SOC2 requirements
Data Integrity and ALCOA
Digital Health
Other pharma & biotech services