Systems GxP, data integrity, quality, validation
PHARMASYS carries out missions of Consulting in Engineering, Quality, GxP Compliance and Data Integrity of automated and computerized systems in the regulated health industry : pharmacy, cosmetics, medical devices.
We offer services in project management support, quality assurance and validation, support and training.
Our interventions rely on 15 years of experience methods and are rigourously based on ISPE ® guidelines. They allow us to respond pragmatically to any regulatory compliance : FDA, Data Integrity guidances, 21 CFR Part 11, cGMP’s, BPF, BPL, BPC, BPD, 21 CFR Part 820, CE Mark, ISO 13485, ISO 14971, IEC 62304…
Our fields of expertise
Production and planning applications (ERP-GPAO-SCM-MES) :
SAP, JDE, Dynamics, BPCS, Mfg-Pro, Adonix, Navision, Produflex, Logistic Manager, Reflex, Dispat-cher, TMS, GPIC, B2U, Octal, Elan, Werum…
LIMS and laboratory systems :
SQL Lims, Labware, Labvantage, TurboChrom, CDS Empower, NuGenesis SDMS, GPPharm, Chemstation, Chromeleon, Provantis, Analyst, Qtrap, MicroVu…
IT R&D (Regulations, Clinical tests, pharmacovigilance) :
Argus, AERS, DragonFly, Aris-g, Oracle Clinical, MisAMM, Eagle, ES1, SAS, Clinsight…
Industrial computing :
IP21, iHistorian, InSQL, RsBatch, inBatch, iBatch, RsSQL, XFP, POMS, PCS7, DeltaV, ProcessLogix, Expirion (Honeywell), PcNodes / DeltaNodes, iFIX, Intouch IAS, RsView, WinCC, Siemens S7, Schneider Premium, Control Logix, P&F…
Cross-functional applications (PLM, GED, QMS, BI and statistic tools) :
TrackWise, Documentum, Ennov, Vdoc, Ennovia, BO, Cognos, SAS, SharePoint…
Cross-functional Best practices :
infrastructures, best practises et méthodologies informatiques : GAMP5, lSO9001, Cobit, CMMI, ITIL, SPICE, méthodologies Agiles…
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.