COMPUTERIZED SYSTEM VALIDATION (CSV)

COMPUTERIZED SYSTEM VALIDATION (CSV)

We specialize in Computerized System Validation (CSV) and Quality Assurance (QA) support services to our global customers in the life-sciences industry.

Computerized System Validation (CSV) and Quality Assurance (QA)
WE PROVIDE COMPUTERIZED SYSTEM VALIDATION (CSV) SERVICES
WE PROVIDE COMPUTERIZED SYSTEM VALIDATION (CSV) SERVICES

to life sciences companies throughout Europe that manufacture products for human use/consumption.

WE ENSURE THAT OUR CUSTOMERS’ COMPUTERIZED SYSTEMS HOLDING GXP DATA ARE VALIDATED
WE ENSURE THAT OUR CUSTOMERS’ COMPUTERIZED SYSTEMS HOLDING GXP DATA ARE VALIDATED

based on GAMP5 guidelines, so that they meet user, technical and regulatory requirements (e.g. FDA, MHRA, ICH, ISO regulations). GxP data are critical data obtained during product manufacturing & distribution and laboratory testing that are mostly included in product batch records and therefore susceptible to inspections by regulatory authorities.GxP = Good [X: Automated Manufacturing, Laboratory, Distribution] Practices.

WE SUPPORT ORGANIZATIONS BELONGING IN THE LIFE SCIENCES INDUSTRY
WE SUPPORT ORGANIZATIONS BELONGING IN THE LIFE SCIENCES INDUSTRY

that produce pharmaceutical products, medical devices, dietary supplements, vitamins, cosmetics, veterinary products and tobacco products to meet the required and applicable compliance requirements for their computerized systems.

What is Computer Software Assurance (CSA), the FDA's new approach to CSV?

We also provide:

  • Quality Assurance support (QA) support throughout the entire CSV lifecycle (Concept, Validation/Project, Operation, Retirement)
  • Change management, CAPA management, periodic reviews
  • Creation and optimization of our customer’s Quality Management System (QMS)
  • Creation of Standard Operation Procedures (SOPs)

Why choose Vimachem as your CSV and QA support partner:

analysis-system-design
WE HAVE OVER 15 YEARS’ EXPERIENCE

in the United States and in Europe in the field of Quality Management and Computerized System Validation.

control-manufacturing-processes
WE ARE FULLY COMMITTED

to creating value for our customers.

Plug & Measure Any Machine
OUR MODEL IS TO PROVIDE CSV AS A SERVICE (CSVAAS) SUPPORT

where our customers choose one or more of our services according to their priorities and needs.

Connects to Everything
WE PROVIDE THE REQUIRED SOLUTION PACKAGES

to our customers

Specifically our CSV experts provide:

Specifically our CSV experts provide:

  • System risk assessments (ISRA, FMEA, FRA)
  • Computerized System classifications
  • Collection of requirements and identification of specifications (URS, FS, DS CS)
  • Validation project planning and execution (VP, Test Cases, Test Report)
  • Traceability matrix and validation reports (TM, VR)

Quality Management Systems (QMS), Laboratory Information Management Systems (LIMS), Enterprise Resource Planning systems (ERP), Manufacturing Execution Systems (MES), Electronic Laboratory Notebooks (ELN), Laboratory data acquisition software, Programmable Logic Controllers (PLCs) and other laboratory and manufacturing electronic systems that need to comply with industry guidelines (FDA 21 CFR Part 11, EU Annex 11, GAMP5.

Examples of computerized systems we validate

Examples of computerized systems we validate

CSV Assessment, Audit Preparation, and Gap Remediation - Vimachem
Vimachem Validation

Our services are focused on 3 areas:

  • 'As-is' assessment of the validation status of the regulated company’s computerized systems
  • Preparation for audits (prepare for success during inspections)
  • Gap remediation (Validation projects)

READY TO AUGMENT YOUR SHOP FLOOR OPERATIONS?

READY TO AUGMENT YOUR SHOP FLOOR OPERATIONS?

Get started with real-time manufacturing analytics today.

Request a Demo