- FIT / GAP analyzes of existing systems and IT service processes, setting of corrective action
- Checking, correcting and building up of the necessary CSV regulations 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
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 Cloud Computing, AI / Machine Learning, IT Security, ByoD (bring-your-own device), BIG DATA and Industry 4.0 or even Social Media. 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.
Strategic changes:
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
- Excel spreadsheet validation
Other topics
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