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CSV

IT managers are increasingly concerned about the cost and efficiency of their application systems, infrastructure, and internal service processes. Information systems and the technology contained within them have been under pressure for years. Technological change, lean and effective service processes, security and compliance, changing regulatory requirements. And then there are also topics such as social media, cloud computing, ByoD (bring-your-own device), BIG DATA and Industry 4.0. As such, the previously self-contained corporate IT is opening up more and more to the outside world. And it must nevertheless be compliant.

With a well-versed team of experienced IT experts and a methodical, risk-based approach according to the GAMP5 guideline, we deal with your challenges systematically. Our comprehensive template documents have proven themselves in many projects and are constantly being improved. This is how we elaborate future-proof IT solutions for highly regulated companies in the life sciences sector.

Validation of non-validated legacy systems for:

  • Changes in regulatory requirements
  • Changes in business models, additions of products or new markets
  • Merger / demerger situations

Strategic changes:

  • FIT / GAP analyzes of existing systems and IT service processes, setting of corrective action
  • Checking, correcting and building up of the necessary CSV SOPs and templates in the IT service process
  • Suggestions for improving the validation system (lean validation)
  • Audit preparations (e.g. FDA, official or customer audits)
  • IT audits for our customers with suppliers
  • IT/validation project management
  • In-house training

Prospective validation consulting and support for the introduction of software systems:

  • IT-supported business processes, e.g. B. ERP (SAP, MS-Dynamics, CIS-OS, others)
  • LIMS for laboratory processes and automation / control of laboratory equipment
  • MES / SCADA / PLC in production
  • Track & trace solutions
  • QM systems
  • Document management systems
  • Excel spreadsheet validation

Other solutions:

  • CAPA, EBR, intranet, PLC, BIG-DATA, cloud-based applications
  • IT infrastructure
  • Re-validation upon version changes

Other topics

GMP and GxP Services
Consulting in pharmaceutical compliance
Consulting in pharmaceutical compliance
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GMP and GxP Services
Medical Device Compliance consulting
Medical Device Compliance consulting
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Services
Qualification and validation - DQ, IQ, OQ, PQ
Qualification and validation - DQ, IQ, OQ, PQ
About us
Company profile
Company profile
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Services
Process design
Process design

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