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Jul 31

Metadata Driven Solutions

Metadata is data that provides information about other data. Many distinct types of metadata exist, including descriptive metadata, structural metadata, administrative metadata, reference metadata, and statistical metadata.

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Categories: Metadata
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May 24

IT Systems Validation

GMP guidelines require that IT systems must be validated by adequate and documented testing. It is required in all regulated industries: pharmaceuticals, medical devices, food and beverages, cosmetics.

GMP Requirements - “The software development process should be sufficiently well planned, controlled, and documented to detect and correct unexpected results from software changes."

Validation is defined as the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. This is the formal testing to demonstrate that the software meets its specified requirements.

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Apr 30

Data Integrity

Data integiry is very important for any organization. In this post we will describe data integrity and how to implement it.

Categories: Data Integrity
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Mar 28

Purpose of Document Control and its Role in Quality Assurance

GxP/GMP, GDocP, ISO 9000 and documentation

GxP stands for "Good Practice" which is quality guidelines and regulations. The "x" stands for the various fields, for example Good Documentation Practice or GDocP, Good Financial Practice or GFP and so on. There are many instances of these regulations. One instance of GxP is Good Manufacturing practice or GMP.

GMP describes required Quality Management System (QMS) for manufacturing, testing, and quality assurance in order to ensure that products are safe, pure, and effective. GMP has ultimate goal to enable companies to minimize or eliminate contamination and errors which protects consumers from purchasing a product which is not effective or even dangerous. GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics.

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Dec 31

Headless CMS - Contentful

In the last post, we have described headless CMS. Headless CMS architecture is rising in popularity in the development world.

This model allows breakthrough user experiences, gives developers the great flexibility to innovate, and helps site owners future-proof their builds by allowing them to refresh the design without re-implementing the whole CMS.

One of headless CMS is Contentful. Contentful platform lets you create, manage and distribute content to any platform. It gives you total freedom to create your own content model so you can decide which content you want to manage.

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