Computerized System Validation and Quality Assurance Services

Vimachem Industrial Solutions, alongside its partner CCG Solutions GmbH, is offering Computerized System Validation (CSV) services and Quality Assurance (QA) Support to its customers in the life-sciences industry.

Why choose Vimachem-CCG Solutions as your CSV and QA support partner:

  • We have over 15 years’ experience in the United States and in Europe in the field of Quality Management and Computerized System Validation.
  • We are fully committed to creating value for our customers.
  • 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.
  • We provide the required Solution packages to our customers.

Computerized System Validation (CSV) and Quality Assurance (QA) Services

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.

  1. We provide Computerized System Validation (CSV) services to life sciences companies throughout Europe that manufacture products for human use/consumption.
  2. 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.

3. 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)

click to enlarge

Specifically, through our collaboration with CCG Solutions GmbH, 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)

Examples of computerized systems we validate are:
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.

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)

click to enlarge