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 …
The lack of linkages between functional food and nutraceutical (FFN) and NHP stakeholders was identified as a key factor impacting upon the development of a strategic plan for research. It was pointed out that this disjunct between FFNs and NHPs was not just a matter of semantics or legal definitions, although both factors also impact …