GxP system validation management: Computer system validation (CSV) and software solutions for the pharma industry in Bulgaria and Europe

Iceq provides GxP system validation management for the pharmaceutical business in accordance with current regulations. Our professional solutions in validation of paid and free software and smart technologies for the pharma industry make the workflow better, more secure and more satisfying. We provide the following engineering solutions and consulting services for the pharmaceutical industry to the Bulgarian and European markets:

  • Computer system validation CSV or GxP validation of comuterized systems in pharmaceutical manufacturing of drugs and food supplements. Consulting and preparation of validation documents, as Quality Manual and Procedures for QMS, preparation of VP, RA, DS, IQ, OQ and PQ.

  • Project management during implementation process of SCADA, MES and ERP - Microsoft Dynamics 365, Oracle Cloud, SAP Cloud. Validation support throughout the life cycle of GxP computerized systems in pharmaceutical industry and other GMP regulated environments.

There is no room for guesswork in pharmaceutical. By GxP system validation management, we provide end-to-end process management to be fully compliant with:

  • GxP
  • FDA 21 CFR Part 11
  • EU Annex 11
  • ISPE GAMP5

Unvalidated or poorly managed systems can lead to❗

  • critical audit findings
  • delayed product releases
  • regulatory sanctions
  • production disruptions
  • loss of regulatory trust

We help you eliminate these risks.

GxP compliance no-compromise❗

GxP compliance is not optional - it is a regulatory obligation.

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Why choose us❓

  • Specialized in pharmaceuticals and food supplements
  • Real experience with regulatory audits
  • Minimizing risk when implementing ERP systems
  • Clear deadlines and predictable costs
  • We speak the language of QA and IT at the same time

How do we work❓

  • Analysis of your system and GxP scope
  • Regulatory risk identification
  • Building a validation strategy
  • Documentation and testing
  • Audit preparation and long-term support

We transform complex regulatory requirements into a structured, audit-ready and traceable process❗

Definition, organization, preparation and implementation of the entire process, including expert project management, in computer system validation or validation of computerized systems CSV in pharmaceutical manufacturing in the production of medicines, food supplements, veterinary products, cosmetics and bioengineering, according to Standard Operating Procedures SOP and Good Manufacturing Practices GMP. The computer validation we perform is in accordance with GAMP5 and the regulations of US cGMP, FDA 21 CFR Part 11 and EU GMP EudraLex - Volume 4 GMP guidelines, Annex 11, Computerised Systems.

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