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The process of buying electricity has recently become quite interesting, as there are modern tools to help you make this type of purchase. However, it is worth keeping in mind that the mechanisms that are in use at the moment are quite unusual. Though it will be actual only for those businessmen who are not …

Tik tok is a newly emerging social network specializing in short videos. Tik tok is already ahead of its competitors in many respects, so in the near future it may become the most popular social network, and thus will bring huge profits to accounts with a large number of subscribers. To become one of the …

The FDA is prolonging public discussions related to the safety of cannabis products containing drug-free cannabinoids, as documents sent and reviewed by government officials with relevant information have provided extremely controversial data and do not allow professionals to make an unequivocal decision. On the pages of the profile electronic edition of hemp producers, the question …

(Competence Training and Awareness is now found in clauses 7.2 and 7.3 in the ISO 9001:2015 Standard.) Managing a company requires more than just making sure processes move smoothly and outputs reach quality standards. It also requires the careful and considerate oversight of your personnel – the individuals who are responsible for making sure those …

Thousands of biotech pharma companies are conducting excellent research for the development of novel medicines for existing and unmet needs.

In my experience, I see a lot of companies using trend charts and statistics to get a view of their process, when what they are actually doing is avoiding looking at their processes and waving meaningless numbers around.  While this doesn’t seem to make sense, when I look at the misuse of the data, I …

The US FDA has made a formal announcement of its intention to replace certain aspects of the existing Quality System Regulation (QSR) with specifications of the international consensus standard ISO 13485:2016. This change is currently at the proposed rule stage.

The Quality-by-Design (QbD) concept is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management [ICH Q8 (R2)].

In essence, the standard states that ‘person(s) doing work… shall be competent‘. Most businesses take care of this, although record keeping often needs improvement to satisfy standards requirements.

Total quality management (TQM) has begun to influence national business systems and is widely seen as a “revolution” in management. TQM initiatives continuously search the needs of the customers and incorporate them in the organization on an ongoing basis.