May 2015

ComplianceControl

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Deviations Are Good For You!

There seems to be much ducking and diving when, for example, an issue comes up in testing. So, is it a deviation or not?

On the one hand there is the tendency to avoid raising a deviation at all costs; it looks bad; it is a lot of work; I am in a hurry etc. At the other extreme is the classic test script error, I had one the other day, I was asked if because the word “the” has been missed off the test script, that would warrant a deviation being raised. The quick answer is “no”, but on further investigation it turned out that the “the” was missing from the system response and that the test script had in fact correctly included “the” in the expected response.

I try to keep it simple, if the system is operating correctly to specification, then generally it is not a deviation unless the tester failed to follow testing procedures. However, it needs to be made very clear on the test script what happened. The test script can be marked up appropriately and it should be explicitly stated that the system is working according to requirements. If there is any doubt, or the explanation is so long that it does not fit on the test script, then it is better dealt with as a deviation.

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Brief overview of key changes coming with ISO 9001:2015

For those familiar with ISO 9001:2008, here is an overview of the changes clause by clause:

Clause 4: Context of the Organization. This deals with the context of the organization, with a focus on senior management, to understand the relationship between risk, challenges, and management systems.

Clause 4: Process Management. The determination of process risk and the allocation of responsibilities.

Clause 5: Leadership. This aims to align the company’s direction with quality management, to look at risk identification, assessment and management from multiple directions, especially from the senior management.

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Computer System, Medical Device and Software Validation GAMP5 Training

Compliance Control Ltd. are holding next months training course on the 18th June. To view the agenda and for more information, click on the link here.

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Compliance Control Weekly Webinars: How can SME's Manage Quality in a Cost Effective Way?

Compliance Control Ltd. will be hosting next months webinars on the 3rd and 17th June between 15:00 - 15:30 (GMT). The sessions will explain to SMEs how they can manage their quality in a cost effective way with an Electronic Quality and Document Management System. For more information about these events, click here.

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Compliance Control UKSPA Good Practice Guide “Electronic Quality Management System for SME’s”

The guide is aimed at Science Parks, start up companies and SMEs who require an understanding of what quality management systems are, how to create a paper based quality management system and how even the smallest of companies can now use an affordable electronic quality management system. If you would like to request a free guide please click here.

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