qcipharma Quality Compliance - Division:
Consultancy Services specialized in FDA regulations, Electronic Records and Electronic Signatures 21 CFR Part 11, GxP, EU Annex 11, GAMP5, Security, Data Integrity, Traceability and Audit-Trail specialist. Full Computer Systems Validation(CSV) projects. Quality System Audit(QMS) for Software Development companies. Consultancy preparation documentation for Validation, GAP Analysis, SOP's, Internal Quality Policy. FDA. Data Integrity Audits (Attributable, Legible, Contemporaneus, Original, Accurate).
Large experience in advising software developers/integrators regarding regulatory compliance in the Pharma, Medical Devices and Clinical Research sectors. Assists third parties in the selection of LIMS systems for compliance with 21 CFR Part 11, advice during the Demo and decision meetings. QMS quality management system, IT deliverable documentation, how to apply 21 CFR Part11 and GAMP5 to software at the level of programming, training and as a company strategy.
QCI Software & IT Services:
Bespoke Development of customized Enterprise Management Computer Systems(ERP, CRM, LIMS, EDMS). Experts in PROGRESS 4GL Programming Language and Database Admin, v.5, v.6, v.7, v.8, v.9 and OpenEdge ABL v.10, v.11, v.12. Admin.B.D. Progress OpenEdge RDBMS, ORACLE DB, SQL Server, MySQL. Referential integrity. Ensuring the Transactional Integrity of a Computer System. Database index optimization for maximum data access/transaction performance. Custom Systems Developer in OpenEdge ABL, Python3, C ++, Java, SQL92, PL/SQL, TransactSQL, PHP, HTML, Javascript/TypeScript, CSS, Cobol, Basic. Data Analytics Development, KPI and Dashboards with Power BI. Agile Development, SCRUM, Kanban, Jira, Continuous Integration/Continuous Deployment(CI/CD). Worked with following Operating Systems: Windows, Unixware, Solaris, HP/UX, SCO Unix, AIX, Ubuntu Linux, MSDOS, MacOS, AS/400.
Company Details
- Founded
- -
- Address
- Pizarro, 51 3-3, Mataró,barcelona 08302,spain
- Industry
- Pharmaceutical Manufacturing
- NAICS
-
Pharmaceutical and Medicine ManufacturingMedicinal and Botanical ManufacturingPharmaceutical Preparation ManufacturingIn-Vitro Diagnostic Substance ManufacturingBiological Product (except Diagnostic) Manufacturing
- Website
- qci-web.com
- Keywords
- Software Consultancy., Computer Systems Validation (Pharma)., FDA, 21 CFR Part 11, GAMP5 Conferences&Training., Medical Devices, Clinical Research, Pharma Industry, Biotech, QSR 21 CFR Part820, EU Annex11, LIMS specialists, Audit Trail & Data Integrity, Business Management Computer Systems bespoke Development, Quality Compliance, QA-IT, CSV Services, 21 CFR Part210/211, GxP.
- HQ
- Mataró, Barcelona
Quintana Consultoria Informatica S.l. Questions
Quintana Consultoria Informatica S.L.'s website is qci-web.com
Quintana Consultoria Informatica S.L.'s LinkedIn profile is https://es.linkedin.com/company/q.c.i.-sl
Quintana Consultoria Informatica S.L.'s industry is
Pharmaceutical Manufacturing
Quintana Consultoria Informatica S.L.'s top competitors are
Cloudinfo Inc,
Accumulus Synergy,
Altence,
Mack Digital Solutions,
Agiledev S.r.o.,
Animatrics Software Services,
Techxpert,
The Jira Hub,
Nsdic,
Quantana.
Quintana Consultoria Informatica S.L.'s categories are Pharmaceutical Manufacturing
Quintana Consultoria Informatica S.L.'s founding year is 1999
