It is not always necessary to replace your legacy systems to comply with current regulations...

The "Wrap & Comply" concept looks at working with your current system components to minimize your validation effort.  Maximizing the re-use of hardware and software will enable you to "Wrap" your legacy system in a compliant architecture in order for the GxP system to "Comply" with regulatory requirements including the FDA's 21 CFR Part 11.

Save time and money...

  • Re-use existing hardware
  • Re-use existing software
  • Minimize SOPs
  • Improve plant efficiency and quality
  • Faster time to market
  • Reduce validation
     

Let us help you identify the non-compliant systems and take the necessary remediation action to validate them:

  • Gap analysis - Identify computer system validation gaps
  • Coverage Assessment - Determine which GxP rules must be satisfied
  • Risk Assessment - Determine and prioritize potential compliance actions
  • Mitigation/Remediation Plan - Formulate a corrective action plan addressing the deficiencies following the rule: "Maintain as much of the existing hardware and software as possible"
  • Implementation - Implement corrective actions
Waarom kiezen klanten voor Eurotherm?
  • Wereldwijde expertise en ervaring in het leveren van farmaceutische en biotechnologische oplossingen.
  • Bewezen track record in het snel leveren van oplossingen met optimale ROI (Return on Investment).
  • Meer dan 40 jaar ervaring in regelingen, data management en schaalbare automatiseringsoplossingen.
  • Kosteneffectieve oplossingen om de betrouwbaarheid en efficiency van uw processen gedurende hun volledige levenscyclus te verbeteren.
  • Bewezen expertise in het werken en integreren met meerdere leveranciers en platforms.
  • Gespecialiseerde teams met uitgebreide ervaring in het valideren van systemen.
  • Wereldwijde expertise, lokaal support en ondersteuning.
  • Een team om mee samen te werken, een partnerschap voor succes.
What our customers say about us

"When I came for the supplier audit I got a warm feeling for this company. I knew I am going to have the first release of the software, but was confident that Eurotherm will deliver. To be honest I was expecting to have many issues, in fact we had very few. The project has gone very smoothly."

Astra Zeneca, Macclesfield - Large Scale Lab Facility



It has been a great team work. It has gone very well, and I wish every other project was like this."

Jacobs Engineering



"Quality of documentation made my life easy. Best validation documentation I have ever seen."

ITS



"The company has a long history of working to formal design design standards and this is reflected in a well developed and cohesive set of procedures. There is no doubt that Eurotherm have the capability to implement software development to the standards sought."

Merck Sharp & Dohme, Cramlington, Newcastle-upon-Tyne

Stability Rooms Environmental Monitoring System

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