It’s a fair question - especially when you’re staring down the barrel of an audit, short on time, and knee-dee...
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It’s a fair question - especially when you’re staring down the barrel of an audit, short on time, and knee-dee...
A Quality Management System is a requirement for medical device developers across the globe. But should you bu...
Managing clinical trial documents manually can be a major headache. From consent forms to sample tracking logs...
If your company needs to certify your Quality Management System (QMS) to the ISO 13485 standard, knowing how t...
When you’re bring a medical device to market, you’re stepping into one of the most competitive and regulated i...
SMEs creating a digital Quality Management System (QMS) often turn to familiar, digital tools to build a solut...
What are the 7 stages of the document lifecycle? Why is managing and controlling the lifecycle a critical part...
How should you structure your documentation to meet the requirements of ISO 13485?
Training management is a big deal for medical device developers. Get it wrong, and you risk fines, product rec...
The regulations and literature surrounding medical device development are packed with acronyms and technical t...
There are different ways companies can build required quality management systems, from using traditional paper...
The medical device development process is typically broken down into five distinct phases. Each one requires i...
Documentation continues to be of vital importance to medical device development in the age of AI. One example?...
Box is a popular cloud-based content management solution that companies use to manage files and collaborate on...
Inadequate document review is often the root cause of failure in new product development and manufacturing pro...
The integration of Artificial Intelligence (AI) into medical devices represents one of the most promising yet ...
There are many eQMS platforms out there that have been helping medical device developers bring their products ...
In the past, document management was an unglamorous business. Not every company was digitised, and those that ...
Here’s the truth. Cognidox was never conceived as an eQMS platform, but that’s been the secret of its success ...
MasterControl is one of the most widely known electronic Quality Management Systems (eQMS) in the life science...
Cambridge, UK, 22 October 2024: Cognidox, a leading provider of document management solutions for high-tech, m...
What’s wrong with SharePoint, anyway? Why shouldn’t it be used as a document management system (DMS) for a gro...
Having a repeatable procedure for Corrective and Preventive Action (CAPA) is a key FDA requirement for medical...
An Electronic Document Management System (EDMS) is a software that centrally stores and organises documentatio...
Would your business benefit from using electronic signatures within your digital quality management system (eQ...
The FDA’s new QMSR is dropping the reference to the DHF (Design History File) when it takes effect in 2026. Bu...
Medical device audits can be a source of stress for developers and manufacturers. But what exactly are the aud...
In the biotech scale-up space, your data and documentation are often the extent of your IP. That’s why you nee...
With complexity and costs rising, fabless semiconductor companies need to do all they can to keep their flow a...
Q-Pulse (by Ideagen) is a long-standing quality management system used across pharma, aviation, and life scien...
EU Annex 11 provides guidelines for the use of computerised systems in ensuring Good Manufacturing Practices (...
ISO 14971:2019 defines the international requirements of risk management systems for medical devices. How does...
Dubbed the 'combination of money and molecules', Biotech is a famously hard sector in which to find and fund s...
Post-Brexit, there is still confusion about the future use of the UKCA (UK Conformity Assessed) markings and w...
WTH is FDA 21 CFR Part 11? That’s a question many life science developers wanting to access the US market must...
Transferring data to a new electronic Quality Management System (eQMS) can seem like a daunting prospect. Here...
On the 16th of May, Cognidox welcomed nearly 100 attendees from across the high-tech, medical device, and phar...
It’s the job of your corrective action process to identify and eliminate the systemic issues that will prevent...
Managing the integrity and accessibility of a PSMF (Pharmacovigilance System Master File) is a key challenge f...
What does it mean to 'control documents'? And who needs a formal document control system to manage and optimis...
Managing deviations from standard operational procedures is critical to product quality and regulatory complia...
The Cognidox team is delighted to announce we will be hosting CogniCon 24 on 16 May 2024. This is a networking...
Google Drive is a cloud-based program that allows you to create, edit, store, and share documents. Many busine...
ICH Q8 R2 are international guidelines for ensuring Quality by Design in pharmaceutical development. Here’s wh...
How do you log and deal with non-conformities so that faulty products don't end up in the hands of customers? ...
A Trial Master File (TMF) is a comprehensive collection of documents that ensures the conduct of your clinical...
Data integrity is central to the safe development and manufacturing of every life-science product on the marke...
Navigating the complexities of ISO 13485:2016 can seem daunting, but understanding its requirements is crucial...
The case for ditching paper based QMS (Quality Management Systems) can seem like a no-brainer. But with choice...
In 2008, the ICH Q10 Pharmaceutical Quality System (PQS) guidelines introduced a comprehensive model for an ef...
Cognidox and Qualio are both digital quality management systems (QMS) with a focus on the life science and med...
In medical device development, two critical stages of the design process are often confused: design verificati...
What if you could gain approval to sell your medical devices anywhere in the world, by completing a single, re...
What’s the cost of quality? Can it, like QM guru Philip Crosby argued, really be free? Like most things in bus...
Controlling and documenting IQ, OQ and PQ effectively is a complex and time-consuming process for life science...
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