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Good documentation practices (also known as GdocP or GDP) are guidelines for document management and control d...
Good documentation practices (also known as GdocP or GDP) are guidelines for document management and control d...
Many medical device consultancy practices work on a fee-based model, helping clients with regulatory and quali...
A QMS should ultimately help guard against customer harm or dissatisfaction, by guarding against the risk of f...
Developers who want to release a medical device in the US need to seek permission from the FDA. Depending on t...
The semiconductor shortage continues to ravage many sectors. With its reliance on electronics for driverless t...
Greenlight Guru has been marketed since 2013 as the first digital eQMS (electronic Quality Management System) ...
Migrating to a new eQMS is a big step for any medical device company, with many pitfalls for the unwary. What ...
The rise of RISC-V seems inexorable. It’s being touted as an answer to the drastic slowing of Moore’s law. It’...
Having a document control system in place is a requirement of quality standards and regulations around the wor...
Cambridge, UK, 3 May 2022: Cognidox, a leading provider of document management solutions for the high-tech, me...
DHF, DMR, DHR… to the uninitiated they might sound like out-of-town furniture stores or airport codes for exot...
For some companies simply managing their documentation is enough to support their business goals. But others n...
QC is about detecting defects in your finished product, while QA is about preventing the defects from occurrin...
The Device Master Record (DMR) is one of the ‘holy trinity’ of files that developers need to collate and maint...
30 years ago the FDA introduced robust new requirements for medical device design control following a string o...
A document management system (DMS) is a method of managing, storing and retrieving all the documentation a bus...
An Electronic Document Management System (EDMS) is a software that centrally stores and organises documentatio...
In medical device development, document controls are the building blocks of an ISO and FDA compliant Quality M...
Are you looking for ways to build and maintain the most efficient, ISO 13485 compliant QMS as your company con...
With complexity and costs rising, fabless semiconductor companies need to do all they can to keep their flow a...
DropBox is a file sharing platform familiar to millions throughout the world. Once a personal file storage and...
Inflexible SOPs, complicated interfaces, training and maintenance requirements. Traditional document control s...
ISO 9001 requires you to control the document lifecycle to improve the efficiency and effectiveness of your bu...
Chaotic document management is wasting the time and energy of businesses around the world every year. But in s...
A Quality Management System is a requirement for medical device developers across the globe. But should you bu...
How should you structure your documentation to meet the requirements of ISO 13485?
What are the 7 stages of the document lifecycle? Why is managing and controlling the lifecycle a critical part...
In this blog, Shaun Knights, Head of Quality at period care company Callaly, tells us why his start-up needed ...
Document controls are a fundamental requirement of every medical device regulatory regime. They are the ‘build...
Building a quality management system is never a quick and simple process. But in medical device development, w...
Following Britain’s exit from the EU, all non-UK medical device and IVD manufacturers who want to place their ...
IVD device regulation is about upping the bar—it’s about making products to a higher standard and ensuring the...
ISO 9001:2015 and its related quality standards are all based on the ‘Seven Quality Management Principles’ def...
How much control do you have over the documents your business generates? How much do you need?
The Covid pandemic has brought new attention, investment and competition to the IVD sector. But with new oppor...
The EU In Vitro Diagnostics Regulation (IVDR), written in 2017, was developed to replace the existing EU In Vi...
Good Manufacturing Practices (GMP) are intended to ensure that pharmaceutical products, medical devices and ot...
I worked in one of the large Cambridge-based technology consultancies for many years and was privileged to hav...
I believe that a quality strategy is a vital element to the success of a business. Quality of product and oper...
Mention ISO 9001 to most people, or tell them that you implement quality systems, and they'll start glazing ov...
Colocation was one of the central tenets of the Agile manifesto, but times have changed. With all the new digi...
How does your organisation authorise, authenticate, document and police the use of electronic signatures withi...
If you want to develop a Quality Management System that meets the regulation and powers your commercial succes...
As your computer waits to load up Teams, Zoom, Slack, Accello and countless other collaboration apps every mor...
Can product innovation really happen by accident? Penicillin, Viagra and the humble Post-It note were all famo...
Does your Document Management System (DMS) apply the five Lean principles to the way you work?
Companies often embark on business process modelling projects with the best of intentions. Modelling may be a ...
Last year, Slack, Zoom and countless other companies hoovered up business as companies shifted to support new ...
For those who need ISO 9001:2015 certification, virtual audits are currently taking the place of face to face ...
Process verification and validation should be a key part of a medical device manufacturer’s QMS. But what’s th...
In the history of product innovation, stories of happy accidents abound. The list of inventions stumbled upon ...
Remote collaboration is the new normal and set to be a major feature of the post-Covid world. Workers have fou...
Choosing and installing a med tech eQMS is a resource and time-hungry undertaking. And the stakes are high. If...
Cambridge, UK, 18th Jan 2021: Cognidox, a leading provider of document management solutions for the medical de...
Would your business benefit from using electronic signatures within your digital quality management system (eQ...
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