Author: admin

(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.

Cheaper. Renting cloud infrastructure from an IaaS provider is almost always cheaper than relying on your own servers. Moreover, when you have no tests to run you won’t get charged for servers that are lying idle.

It is important for an organisation to agree on what the meanings of Quality Assurance (QA) and Quality Control (QC). Both form an integral part of the organisation’s quality management plan, and the effectiveness of delivery teams relies on the differences being well understood by all stakeholders, including management.

Startups grow very fast but they also fail very often. The majority of entrepreneurs think that they will create and build a really good product but only an idea cannot guarantee a successful project realization. Did you wonder how many startups fail? Unfortunately, according to Startup Genome Report Extra, 90% of startups fail. Startupers use …