Systems GxP, data integrity, quality, validation
Reasons to choose Pharmasys
PHARMASYS is a service company 100% dedicated to the Health industries and recognized European leader and 100% dedicated to Data integrity, Quality and validation of GxP regulated computer systems: Data integrity, FDA, 21 CFR Part 11, cGMP’s, BPF , BPC, BPL, 21 CFR Part 820 …
PharmaSys positions itself on new practices in terms of GxP compliance, based on the Risk Analysis approach driven by the FDA through the “cGMP’s for the 21st century” approach and the challenges of Pharma 4.0 which have given birth to a new framework of repositories:
- Data Integrity Definitions and Guidance for Industry (FDA & MHRA),
- 21 CFR Part 11 New guidance & EU GMP Annexe 11
- GAMP 5, 2008 & ASTM E 2500
- ISO13485, iec62304 et ISO/TR 80002-2 for medical devices…
Responding to the current challenges of the “Pharma 4.0” Health industry, requires specialized skills as well as a triple expertise that Pharmasys has built to support you with rigor, pragmatism, flexibility and efficiency for your needs around GxP mastery of your systems:
- regulatory expertise: Data integrity guidance, BPF, GMP, BPC, BPL, cGxP’s ,, cGMP’s, FDA 21 CFR Part 11, Part 820, iec62304, ISO13485, ISO / TR 80002-2…
- Methodological expertise and IT / IS best practices: mastery of the life management of systems and associated methodologies: GAMP5, Cobit, CMMI, ITIL, SCRUM, etc.
- functional expertise: IT infrastructure, databases, networks, ERP, WMS, Serialization, Aggregation, command-control, supervision, Batch S88 managers, traceability systems, MES, Quality control system, LIMS, management systems ” clinical trials, Pharmacovigilance, Regulatory Affairs, Quality management tools, GED / edms …
Thanks to its unique expertise and quality of service, Pharmasys has become a recognized European leader in consulting around the Data integrity and compliance of GxP systems and was notably elected to the 2018 and 2019 Palmares by Les Echos in the TOP 500 of Growth Champions in France.
We are exclusively dedicated to the life sciences industries.
Our methods are built on ISPE guidelines.
Our services are perfectly tailored to fit your requirements.
Results are guaranteed.
Words of customers Pharmasys
« Very good methodological framework to deploy on site. » - Mme L.
« I appreciated the claimed "common sense" of the GAMP 5 approach. » - M. P.
« A global view with a focus on deployment at bioMérieux. » - M. E.
« Good step back on the subject of IT validation. thank you so much. » - Mme B.
« Very good training which will allow the company to approach the next changes with bases and a good structure. » - M. S.
« I could appreciate the trainer's adaptation to the needs and questions asked, but also the conviviality of the exchanges. » - Mme S.
« Excellent training and an experienced trainer with very good listening skills. » - M. A.
As part of our development, we are strengthening our teams.