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Audit Readiness

Is your organisation audit-ready?

​The challenge

Audits interfere with the routine. The prospect of not passing an audit or an inspection is a disaster scenario for most companies. This is why the period between announcing and carrying out the audit is generally particularly labour intensive.

Typical problems:

  • The manufacturers of pharmaceutical products are now under twice as many obligations – they carry the responsibility for both their own and purchased products and services and need to audit their suppliers and themselves.
  • Additional burden is time-consuming and obliges employees.
  • Work that has previously been neglected and must be available for the audit is completed in haste. Other important tasks are left as a result, that in turn become a problem at some later stage


The solution

Audit readiness at any time.

Get support from external experts who know the life sciences industry and the processes for audits well. They do not only lead you succesfully through audits (CSV audits, GMP audits, supplier audits, etc.) but also ensure the sustainable audit readiness of your organisation.

We offer a professional audit team that is well trained and certified. The employees have many years of experience in the life sciences industry and have partly worked as authorities auditors.

The benefits:

  • Successful audit results (CSV audits, GMP audits, supplier audits,…)
  • Professional review of your contract partners and suppliers
  • A quality assurance system that always keeps you “audit-ready”: In this manner, the preparation time for future audits is shortened and resources are saved.

Our audit tracking tools are field-tested and customised for each audit situation.

We support you when auditing other companies and if you are subjected to audits yourself. 

 

 

Michael Clausen+45 3077 9120mccs@nnit.comAssociate Vice Presidenthttps://www.linkedin.com/in/michaelclausen1975/?originalSubdomain=dkMichael Clausen

 

 

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Computer System Validation (CSV)https://www.nnit.com/Life-Sciences/quality-management/Pages/Computer-System-Validation.aspxComputer System Validation (CSV)
Compliance & Validationhttps://www.nnit.com/Life-Sciences/laboratory-informatics/Pages/Compliance--Validation.aspxCompliance & Validation
Strategy & Guidancehttps://www.nnit.com/Life-Sciences/laboratory-informatics/Pages/Strategy--Guidance.aspxStrategy & Guidance
Laboratory System Transformationhttps://www.nnit.com/Life-Sciences/laboratory-informatics/Pages/Laboratory-System-Transformation.aspxLaboratory System Transformation
Requirement Specification & Vendor Selectionhttps://www.nnit.com/Life-Sciences/laboratory-informatics/Pages/-Requirement-Specification--Vendor-Selection.aspxRequirement Specification & Vendor Selection
Application Serviceshttps://www.nnit.com/Life-Sciences/laboratory-informatics/Pages/Application-Services.aspxApplication Services