Pharmaceutical, Biotech, and Cosmetics Sector
At SQS, we have been working with companies in the pharmaceutical, biotechnology, and cosmetics sectors for over 20 years.
We work with top-tier clients on computer system validation and manufacturing line validation.
We have experience in the regulatory field of both the FDA (United States) and the EMA (European Medicines Agency).
Computer Systems Validation
We ensure regulatory compliance in GxP environments through full lifecycle validation of critical IT systems (ERP, LIMS, MES, SCADA, SAP, etc.).
Qualification of Equipment and Facilities
We guarantee that equipment, utilities, and clean rooms meet design and GMP requirements, from installation to operation.
Warehouse Qualification and Validation
We ensure that storage areas comply with regulatory requirements (GMP/GDP) through thermal mapping studies, IQ/OQ/PQ qualification, and validation of critical environmental conditions such as temperature and humidity. This ensures product integrity throughout the entire logistics chain and facilitates compliance with regulatory audits and inspections.
Validation of Manufacturing Lines
We verify the correct performance of production lines through IQ/OQ/PQ qualification, ensuring GMP compliance and consistency in processes.
Data Integrity
We implement data integrity strategies based on ALCOA+ principles, ensuring complete, reliable, and traceable records in regulated environments.
GMP Consulting and GxP Audits
We offer internal and supplier audits, gap analysis, and support during inspections by regulatory authorities (EMA, FDA, AEMPS).
Specialized technical support
Consulting and specialized technical support, contributing our knowledge, experience, and valuable solutions to each project.
Training
We offer customized training programs in system validation, GMP, data integrity, and regulatory compliance, ensuring that internal teams acquire the practical knowledge necessary to maintain quality and successfully pass audits and inspections.
Related articles
- Update of GMP guidelines – Chapter 4, Annex 11, and new Annex 22
- GAMP5: A risk-based approach to GxP-compliant IT systems. Second edition
- FDA guidance on IT system validation: CSA
- FDA guidance on electronic records and electronic signatures (21 CFR Part 11)
- European regulations on the validation of computerized systems: GMP Annex 11
Contact an expert
If you would like to know more about this topic or have any other questions, please do not hesitate to contact us.
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ISO 9001:2015
ISO 14001:2015
UNE-ISO/IEC 20000-1:2018
ISO/IEC 27001:2013
UNE-EN ISO/IEC 17025:2017
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Approved IDS Evaluation Facility
ISO 9001
ISO/IEC 27001
ISO 20000
ISO 14001
UNE-EN ISO/IEC 17025
ENS-nivel alto
ENS-nivel medio
Approved IDS Evaluation Facility
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