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Jan 30

Digital Transformation

Digital technology is drastically changing how companies do their business and companies' relationship with their customers. While customers gain the power of information and choice, digital technology dramatically improves the economics of business. The rules of business are being rewritten nearly every day with new digital technologies. Every company has a unique digital transformation opportunity.

However, doing so involves far more than merely converting paper processes to electronic ones. Companies undergoing a digital transformation also need to make sure that all of their digital processes are interconnected. Even more important, though, digital transformation requires a company-wide culture transformation.

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Dec 29

Electronic Signature and Content Management

At this time of digital transformation, it is difficult to talk about managing content management without talking about using electronic signatures. E-signatures make it possible to create digital workflows, help to maximize ROI from content management, and enhance productivity, compliance, security, and analytics.

Quite a few content management tools include e-signature implementation such as SharePoint, Box, and other content management systems (CMS).

Electronic signatures, digital business, and content management are interdependent. Without e-signature capability, documents continue to be printed for signing, then photocopied, shipped, corrected, imaged back into the system, archived, and shredded. 90% of the time and cost of labor dedicated to managing paper can be saved by using e-signatures. There are also other benefits of using e-signatures such as faster decision making, shorter sales cycles, and improved customer experience.

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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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Apr 30

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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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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