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qmsWrapper Blog

Validation efforts

Validation efforts

When an eQMS is implemented in a medical device company, such software must be validated.  It should be ensured that the system is working and that it meets the requirements of ISO 13485. Validating the software decreases risk and legal liability, and provides evidence that the system fits for purpose.   Software validation process Validation for intended use...
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Benefits of remote auditing

Benefits of remote auditing

Remote audits can have many benefits in terms of efficiency, access to competencies, increased reach and risk mitigation. Check out what the benefits might be.
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Management review – Lecture 23

Management review – Lecture 23

It’s is one of the methods dictated by the ISO 9001 standard for monitoring the QMS and evaluating its performances and effectiveness – learn how with qmsWrapper.
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Internal audit – Lecture 22

Internal audit – Lecture 22

It’s an effective tool that is used for self-assessment of your organization and to determine the extent to which it fulfills the QMS requirements – find out more with qmsWrapper.
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Resources of Support – Lecture 9

Resources of Support – Lecture 9

They are critical zones and should be support for achieving your QMS goals, aligned with the objectives – how, why, when – more here in lectures by qmsWrapper.
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