Services of Computer Systems Validation in GxP
Validation and Consulting Services
by
qcipharma
-Full (CSV)Computer Systems Validation Projects (ERP, LIMS, EDMS, CDS,...)
-Reviewing/Assess. of Protocols/SOP's/IT Docs/QA Inter.Policies
-CSV Training: GxP, 21 CFR Part11, EU Annex11 and GAMP5
-Audits to Software Provider/IT Dpt.(QMS=Quality Mgt.System)
-Data Intregrity and Traceability Audits
-CSV Project Management (CSV Management)
-FDA compliance consulting of 21 CFR Part11, GAMP5, 21 CFR Part210, Part211, Part820
-Monitoring and Resolution of Non-conformities and Deviations
-CAPA Design and Management in a GxP environment
-SOP's Edition/Review
-Technical IT Docum. Design/Edition/Review(DRP, BCP, Backup&Recovery, etc)
-QA-IT Corporate Manager service in person at your facilities(near your IT Department)
-GAP Analysis of Documentary situation(CURRENT Situation versus DEMANDED Situation)
-Remote Review/Assessment of QA-IT Documentation
21 CFR Part11 and GAMP5 Compliance
Any Computerized System in a GxP environment that manages critical data (GxP relevant) stored in a "durable" medium, must comply with 21 CFR Part11 and GAMP5 Methodology:
The FDA Regulation for Electronic Records and Electronic Signatures 21 CFR Part11, as well as the GAMP5 Methodology (Software Cat, V Diagram, Nomenclature, Software Provider Responsibilities, Risk Mgt., QMS, ...) applied in the Design and Programming a System,
and subsequent correct Validation, generating sufficient evidence of its compliance,
allow guaranteeing Patient Safety, Security, Data Integrity, having that continuous Traceability based on a well-defined Audit Trail, use of Electronic Signature,
streamlines, improves and ensures processes in an ERP System, LIMS, Document Management System, SCADA, Chromatography Data Capture ..., to have the Systems under control, and be able to demonstrate it to third parties.
Data Integrity(DI)
The "Data Integrity" is fundamental in the Pharma Industry, Biotech, Clinical Research, Medical Devices.
Having Traceability based on Audit Trail is not enough, we must demonstrate that it works properly in Audits/Periodic Reviews of Data Integrity.
In Computer Systems and their management, there may be interventions in the configuration and administration of the System or the Database, or in unforeseen situations of use (scalability, storage limitation, expansion of concurrent users, connectivity failures, ...)
that may affect the correct information generated from Transactions and Traceability maintained in the Audit Trail.
The qcipharma Division can advise you on how to plan and carry it out. Contact us.
Do you need to validate your computerized systems according to GMP(Manuf.), GLP(Lab), GCP(Clinical Research), GDP(Distrib) (=GxP), 21 CFR Part11 FDA, EU Annex 11 and GAMP5 methodology ?
Do you need to have the Systems under control, and be able to demonstrate compliance to third parties ?
Do you need to be able to successfully pass an FDA-PAI Inspection, a Health Inspection, an European Central Audit, a Third Party Audit, ...?
Contact us, and we'll help you achieve it.