References Computer System Validation
Since its inception in 2001, Arcondis has successfully completed more than 290 projects in the CSV area (Computer Systems Validation) in close co-operation at pharmaceutical and medical technology customers. The following project examples give a little insight into the successful cooperation with our customers. If you want detailed information on individual projects, please contact us. We will gladly arrange direct contact persons at our customers.
Validation
Prospective and retrospective validations, revalidations, validation concepts for — service management tools — document management systems (DMS) such as Documentum, Pergamon, MS SharePoint — ERP systems like SAP, proALPHA, MOVEX — ECC (Electronic Change Control) — EDS (Electronic Data Submission) — LIMS (Laboratory Information Management System) — Excel Sheets (analysis reports) — MedDRA (Medical Dictionary for Regulatory Activities) — CTMS (Clinical Trial Management System) — Work Safety systems (Argus Safety, Oracle AERS, Aris-G ) — labeling systems — MES (Manufacturing Execution System).
SAP Validation
Coaching, planning, coordination and implementation of prospective and retrospective validation projects for the introduction or release changes of SAP systems — Analysis and specification of the relevant GxP requirements, transactions, and modules.
Qualification
IT infrastructure qualification of servers, virtual servers, networks, backup systems, Citrix — qualification of production environments (labeling systems, automated equipment, bar code) — qualification of laboratory equipment — analysis of the qualifications and IT compliance (based on ITIL® and other standards) — FDA compliance of the VMP (Validation Master Plan) — FDA compliance of the application implementation — review of the automation equipment and labeling systems — inspection preparations.
Validation Office
Based on customer requirements Arcondis takes over services such as — creation of the validation master plan (VMP) — preparation and reworking of validation plans, validation reports, progress reports and specification documents — risk-based evaluation of functions — determination of test size — running tests — traceability — project coaching.
Training
Basic training — CSV training and workshops — GAMP 5 training — GLP audit training — custom training — coaching for validation and qualification — project management based on the V-model — preparation for inspections.
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