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   Consultancy Services - Validation & Compliance
    

Aston Dane provides consultancy services both from a technical perspective, based on specific tools and technologies and also on a business level covering the industry areas on which we focus.

This is often beneficial to our customers, who can supplement their skills in key areas, as an extension of their resources without the need to recruit expensive permanent staff or risk losing knowledge by using contract staff.

All of these services can be called on, where necessary, in support of a project, to ensure objectiveness and compliance.

Our capability is provided through experienced, trained staff, to support your business needs.  We can also work with our customers in a number of areas, which may typically be to:

  • Develop a master validation plan
  • Conduct design reviews and supplier audits
  • Establish equipment history files and co-ordinate construction documentation
  • Prepare qualification protocols
  • Perform physical validation
  • prepare final reports 

We have expertise in current aspects of key safety regulation and codes of practice such as 'life cycle functional safety of programmable safety related systems' (IEC61508) where Aston Dane is also a member of the European Core User Interest Group (CUIG).

We actively support a number of organisations including the GAMP Supplier Forum responding to cGMP regulations, such as the US Food and Drug Administration 21 CFR Part 11 addressing electronic signatures and batch records.

We have at our a close network of associates who can supplement our capability where required in specialist areas such as hygiene and environmental management.

These services are most often called on prior to commencement of detailed engineering work, e.g. feasibility or pre-sanction stage, through site audits and supporting client review processes, but may also be called on during later key stage design reviews or qualification stages.    

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