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EU Annex 11 provides guidelines for the use of computerised systems in ensuring Good Manufacturing Practices (...
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...
What is the medical device technical file? What should it contain and how should it be structured? And is it e...
The case for ditching paper based QMS (Quality Management Systems) can seem like a no-brainer. But faced with ...
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...
Medical device audits can be a source of stress for developers and manufacturers. But what exactly are the aud...
Cognidox are delighted to announce the release of our new DocuSign e-signature integration. The new plug in is...
Change control in life science development is critical to ensuring the safety of patients. Having a formal pro...
Chip designs are becoming more complex and expensive to develop, verify and validate. Opportunities for fables...
Clinical research demands strict GCP (Good Clinical Practice) compliance. But many institutions stuck with out...
At last! It’s happened! The FDA has announced the date for the publication of its new Quality Management Syste...
Transferring design to production is a process that can be fraught with risk for medical device developers. Ho...
There are many reasons why organisations need to document their SOPs. From ensuring uniformity in end products...
There’s plenty of document management and file-sharing software available on the market, but not all of it is ...
Of all the quality management ‘gurus’, the late Philip Crosby is one of the most readable. In his book ‘Qualit...
The regulations and literature surrounding medical device development are packed with acronyms and technical t...
Will a phase gate process hold back or enhance your new product development? What are the pros and cons of sta...
A Quality Management System (QMS) is a requirement for medical device developers across the globe. But should ...
How can you help your business evolve its mindset to achieve the most instinctive, frictionless and effective ...
If you’re a tech start-up or growing SME looking to implement an enterprise-grade file-sharing solution and co...
The FDA’s Quality System Regulation (QSR) for medical device manufacturers is commonly known as FDA 21 CFR Par...
The medical device development process is typically broken down into five distinct phases. Each one requires i...
SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar tools to build ...
Monitoring and measuring quality of products and services is a key part of any QMS. But how can you be sure th...
Document control is a key part of any Quality Management System (QMS) and, therefore, a requirement of ISO 900...
How do you transform regular supplier reviews from a box-ticking exercise into a genuinely useful commercial a...
What’s wrong with SharePoint, anyway? Why shouldn’t it be used as a document management system (DMS) for a gro...
Does the fertility tracking app you are developing count as a medical device? What about the imaging software ...
ISO 9001 is the internationally recognised standard for quality management used in many sectors from construct...
The PIP scandal, in which thousands of women were injured by faulty breast implants over a period of twenty ye...
How is the quality of your document review process affecting the speed and efficiency of the way you do busine...
We’ve all been there. We’ve lovingly put the final touches to that important document and saved it to the shar...
Question for you: what exactly is a medical device? Is the product you are developing a Medical Device, an In ...
So, you’ve had your brilliant idea. You know what kind of medical device you want to build. You have a vision ...
Having a repeatable procedure for Corrective and Preventive Action (CAPA) is a key FDA requirement for medical...
There are different ways companies can build required quality management systems, from using traditional paper...
What are the planning requirements for a medical device design and development process? And what tools can hel...
A focus on a quality management system shouldn’t just mean a ‘box ticking’ exercise for an organisation. And i...
When it comes to medical device development, the absence of comprehensive design and development documentation...
How can medical device developers gain FDA approval for their devices and permission to sell their product int...
Qualio is an eQMS platform launched in 2012 by Irish entrepreneur Robert Fenton. From small beginnings, his co...
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) ...
The rise of RISC-V seems inexorable. It’s being touted as an answer to the drastic slowing of Moore’s law. It’...
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...
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...
The race for the development of a Covid-19 vaccine has been an incredible story of fast tracked innovation. Th...
In Part 1 of this series we considered the problem of reinvention, the unstructured nature of information, and...
Throughout the med-tech regulatory literature quality systems are cited as the way GxP (current best practice)...
If you’re not planning to improve your operational resilience, you’ve not been paying attention. How can a dig...
In a previous blog, we wrote that information findability is as worthy a topic for ISO 9001:2015 standards-mak...
When Elon Musk unveiled his ‘bionic pig’ in an on-line event in September there was much hype and more than a ...
Unstructured data present both a compliance risk and a missed opportunity for growing organisational knowledge...
For pharmaceutical and other life science disciplines, the ‘5Ps of GMP’ are a useful way of thinking about the...
Inadequate document review is often to blame for failure in new product development and manufacturing processe...
GMP is part of the best practice guidelines (GxP) which the FDA and other official bodies refer to in their re...
In a Lean approach to product development, customer value is defined as ‘everything the customer is prepared t...
It’s much easier to screw up a new product development process than mastermind a successful one. Here’s how.
cGxP (also known simply as GxP) is an acronym used by the FDA and other regulators within the life science ind...
Research shows one of the key challenges for life science companies is balancing the need for rapid innovation...
The outlook for many companies might be unpredictable at the moment, but access to the right document manageme...
The US human interface company, Snyaptics Inc announced this week that they are acquiring DisplayLink Corp in ...
Managing the quality of medical products as they are stored and distributed brings with it many challenges. Di...
There are five stages of document control critical to NPD and product management. If you have the digital tool...
Last week, news broke that Siemens is acquiring the Cambridge based company and Cognidox client, UltraSoC, in ...
The expense and effort of achieving ISO certification is sometimes regarded as excessive and onerous by SMEs -...
There are four entities defined under the EU MDR and IVDR as “economic operators”. Under the regulation, these...
Cambridge, UK, 22 May 2020: Cognidox, a leading provider of document management solutions for the high-tech, m...
A brief internet search will confidently tell you that there are anywhere between 4 and 8 stages of the ‘ideal...
A lot of us have been challenged by remote working lately, whether it’s the back ache acquired from working on...
Around the world different rules apply for the cultivation, manufacture and sale of cannabis and CBD products....
For medical device developers assembling and presenting all the required documentation for the DHF (Design His...
There's a long-running debate whether a bug or defect tracking software tool is just a synonym for a help or s...
One of the things Covid-19 has shown us, is that the digital agility of an organisation can mean the differenc...
There are many file sharing apps on the market right now. They range from ‘free’ or ‘low cost’ one size fits a...
Developing a robust stage gate process is a vital part of many new product development (NPD) and introduction ...
ISO 13485, the FDA and the MHRA all require medical device manufacturers to have documented corrective action ...
For most high tech companies, developing profitable new products is their entire reason for being.
One of the areas included in the ISO 9001 :2015 is 7.1.6 Organizational knowledge. The stated requirement is: ...
The third edition of ISO 14971 (Application of Risk Management to Medical Devices) was released in December 20...
Many organisations still operate without a central, shared Document Management System (DMS) that effectively m...
Cognidox’s commitment to improving usability and cross platform accessibility continues with the release of v1...
If you took a snapshot of document management around 20 years ago, the general situation was that in my indust...
Managing an NPI process can be fraught with difficulty as each new initiative brings with it the potential for...
Mastering CAPA management is part of the proactive quality mindset that regulators demand, but it is also an a...
We’ve all been there, haven’t we? We’ve all accidentally published online the addresses of hundreds of celebri...
Cognidox’s story is bound up with that of the "Cambridge Phenomenon" the so-called Silicon Fen high-tech clust...
There’s no shortage of words in print and online written by regulators, consultants and software developers ab...
The pursuit of quality in any company depends on your ability to transmit all kinds of organisational knowledg...
What should come first in a med tech project? Product development or documentation?
Companies working in heavily regulated sectors might have been historically slow to change and optimise their ...
Companies are often spurred to undertake business process mapping to improve their quality management.
How do you need your product management process to function? A classic article in the HBR got us thinking abou...
As the 2020 deadline for compliance with the EU’s new Medical Device Regulation (MDR) fast approaches, the EC’...
The Good Automated Manufacturing Practice (GAMP 5 ®) guidelines define a set of core principles for GxP, as pr...
Many high tech businesses who are implementing a Quality Management System (QMS) to gain ISO 9001:2015, are in...
In 1969 quality management was truly the final frontier in the space race. As NASA engineers developed unique ...
A change control process is a vital part of any product development and management function. But if it’s not e...
Advanced Driver Assistance Systems (ADAS) and even driverless cars, once the stuff of science fiction, are rap...
A responsive new product development (NPD) process has always been a key part of a high tech business strategy...
Can you ever make a stage-gate process Agile? Can modern tools and a hybrid approach to Waterfall and Agile br...
Not all business management software solutions are created equal. They come in different shapes and sizes, wit...
Time and costs can soon rack up in a med tech device design and development cycle. But those who have installe...
Issuing a tech product release or a software update can be a challenging process. Handled badly it can result ...
I am a former FDA staff member and now back in the private sector. If you are in Regulatory Affairs, you are i...
From 2022 the In Vitro Diagnostics Regulation (IVDR) will require Notified Body intervention and review for 80...
Google Drive and Dropbox are two of the most popular cloud-based, file-sharing platforms on the market today. ...
From 2020 and 2022, EU Medical Device Regulations will change. This brings certain products into regulatory sc...
Do your systems give you the kind of control over your documentation which really match the organisational, co...
A med tech device that has a poor user experience can be dangerous for consumers and commercially calamitous f...
Google Team Drive is a service which has been available by default to Business, Enterprise and Education G-Sui...
For many companies, compliance is, at best, regarded as a necessary evil, and at worst a never-ending ordeal. ...
There is always commercial pressure on product developers to find better and more efficient ways to collaborat...
Both Box and Dropbox Business are cloud-based file sharing solutions intended to give their customers the free...
Founders of companies are often, by necessity, their own Product Managers. They’re often the ones who have mos...
OK, we admit it, there are definitely more than 7 deadly sins of the product development process. In fact, the...
Box is a popular cloud-based, file sharing solution, designed for use by enterprises to store business documen...
With a supply chain ripe for digital disruption, high tech manufacturing companies must evolve new ways of man...
Document control is a crucial part of any project management process. In this blog post we ask how the right D...
We all make mistakes, but when a product development process fails it can have far-reaching financial and comp...
Business Process Maps are a key part of any Company Management System. They are the flow diagrams that help yo...
There are many competing demands on the attention and resources of a growing business, but investing in the ri...
What is the best document management solution for you and your business, One Drive for Business or SharePoint?...
In part one of this series we argued that one key ingredient for a successful scale-up company is optimisation...
Reports from the U.S. tell us the FDA is continuing to prioritise Proactive Quality Management in the medical ...
Our opening post on this theme introduced the problems that companies face as they transition from start-up to...
One of the main challenges of implementing a Quality Management System (QMS) is ensuring it is actually used f...
It seems everyone is talking about Scale-up companies these days. The term has been around since 2013 (see for...
Business Process Mapping could be the first step you take towards creating a more efficient, profitable and qu...
As we approach the end of 2018 with all its political and economic earthquakes, how can your high tech company...
Adopting a Business Management System (BMS) is a well-established way to manage and control all the processes ...
A failing product development process can cost your sanity, your company’s reputation, and a lot of money. In ...
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