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5 min read.

2023 is almost over. Oh how time flies! As we are entering the last quarter of the year, there are still plenty of conferences and trade shows for you to attend. These events are a great way to stay on top of today’s rapid and sometimes overwhelming ...

Quality risk management is a non-negotiable requirement to comply with ISO 13485 and 21 CFR 820. Yet, every year, Life Sciences companies face warnings from regulatory bodies, such as the FDA in the U.S., the EMA in Europe and MHRA in the U.K. Warnin...

5 min read.

The pharmaceutical industry is one of the most rapidly evolving industries in the world, with new advancements and breakthroughs being made every day. Keeping up with the latest pharmaceutical industry news can be challenging, but fortunately, there ...

21 CFR Part 11 stands for Part 11 of Title 21 of the Code of Federal Regulations. The US FDA issued this final Part 11 regulation in March 1997, which became effective in August 1997. It governs the FDA regulations for electronic signatures and elect...

Lean Thinking is centered around building efficient manufacturing operations by defining value from the customer's viewpoint and continually improving how value is delivered by eliminating wasteful resources or resources that do not contribute to the...

Companies in the life sciences industry need to deal with stacks and stacks of documents. Whether they’re paper or digital, chaos is inevitable if documents are not kept meticulously organized. Document control software is frequently used in the life...

Stacks of paper, what a hassle! Staying on top of who printed what, where, and when is a common struggle for many life science companies. Document reconciliation is even more of a challenge. Printing may be unavoidable, but staying compliant and keep...

Modern healthcare is being shaped by a marked rise in technology use—based on the next generation of personalized medical care. Science, to this end, is bolstering patient centricity, especially as data becomes increasingly available in the public do...

Scilife has a new module! Finally, risk management is made a whole lot simpler, as well as accessible by everyone. In our webinar on Scilife's new Risk Assessment module, CEO Filip Heitbrink discusses:

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