Computer System Validation / Equipment Validation / Process Validation

Especially if you are in pharmaceutical or medical device business then you are familiar with this particular issue!

Are you using computer systems, automated tools (or Excel spreadsheets including formulas) which could impact your products, customers or users?
Well, that means you are forced to validate/qualify your apps and tools.

Are you using new or changed production equipment or did you change existing or introduce new production processes?

That's where we offer various (and scalable) options to get your tools, equipments and processes compliant. Either we can execute it end-to-end or support your own staff:

• Analyze levels of required validation
• Assess according to 21CFR11
• Create all required plans
• Create all resulting reports
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Rating according to GAMP 5
• Update your Design History File (DHF)