Every drug, device & clinical company wants to predict how regulations will impact their future processes. Here are 5 MHRA and FDA changes you need to know about in 2019
Validation costs putting your business off implementing a desperately needed integrated quality management system? Here's how our 5 step validation process genuinely makes it pain-free, efficient and easy to maintain.
How does EQMS help you to comply with FDA title 21 CFR Part 11? This article details exactly how and why EQMS helps you to comply.
Not sure what an audit trail is or where to find one in Qualsys's software? Here's the what, how, where, when and why you need audit trails for GAMP, FDA and MHRA compliance.
DYSIS Medical's Quality & Regulatory Manager Paul Houston shares his industry experiences and discusses the impact of Qualsys's software on his business.
York Instruments Quality Manager Stewart Wilson discusses how he built a quality management system from scratch to bring a new medical device to market - and why he doesn't prepare for his audits.
We asked three of our customers to share their insights and advice for building a life science electronic quality management system. See their responses here.
Find out how Qualsys's software helps you comply with ISO 13485:2016 Design controls.
70% of 510(k) FDA submissions are unsuccessful. Qualsys's Senior Business Development Manager Alex Swan shares some tips to help ensure yours isn't one of them.
Medical laboratories have until September 2018 to transition from CPA accreditation to ISO 15189. We created a gap analysis to help you pinpoint what to change, and where.
Here are three mistakes to avoid when planning your Trial Master File.
Sodexo sliced two-thirds of their auditing time while building a robust HSE management system with our cleaning audit software. Read the details.
Qualsys are delighted to welcome pharmaceutical development company Nanopharm as a new EQMS customer. Read why and how the company will be using EQMS here.
Quality management events in 2015, including ISO 9001:2015 conferences.
Qualsys attend the ISPE GAMP Forum, an event aiming to increase dialogue and practical guidance between those involved in pharmaceutical regulation.
Obamacare is set to create a $350 billion bonanza for Indian and Chinese Pharmaceutical Manufacturers.
Qualsys compliance management software advice and support.
Businesses operating within the Medical Device and Pharma industries are compelled through the FDA and EMEA to instigate a formal validation process to ensure that all software is fit for purpose.