AUDITING

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We offer a variety of auditing services. Typical audits performed include:

Equipment vendor audits
: in a single audit we evaluate the supplier’s quality systems (training, change control, material handling and other) applied to both mechanical works and software development. Financial and organizational aspects can also be covered. Typically the service includes a pre-audit meeting with the organizer of the audit to discuss goals & timelines. Then a draft report is sent out, which can then be finalized after a post-audit meeting to discuss the outcome and possible follow-up actions.

Contract manufacturer audits
: most of the above applies here too. Focus can be on specific aspects of the contract manufacturer’s scope of work (e.g. release testing) or on cGMP standard in general.

Internal CGMP audits
: Periodically evaluating your own quality systems is a GMP requirement in itself. We can do this for you on your own behalf.

Lab audits
: These are performed in collaboration with one of our partners (a former colleague), one of the most knowledgeable in Europe, as far as compliance in the labs is concerned.

Much more is possible. Please send me an Dit e-mailadres is beschermd tegen spambots. U heeft Javascript nodig om het te kunnen zien. for more information.