What Your MedTech Team Needs In A QMS
Medical device companies operate under some of the most stringent regulatory frameworks in life sciences. FDA 21 CFR Part 11, ISO 13485, and EU MDR requirements shape every stage of product...
How Life Sciences Teams Handle QMS Implementation Without Disruption
QMS implementation used to be treated like a background IT project. Get the system in place, hand it off to QA, and move on.
How Modern Healthcare Teams Build Effect Quality Assurance Programs
Quality assurance in healthcare should be focused on enabling safe, scalable growth in one of the most highly regulated industries in the world.
A Closer Look At Software as a Medical Device (SaMD)
Software is no longer just a component of medical devices. Increasingly, it is the device.
The Complete Guide to Cloud QMS for Life Sciences Teams
Enterprise QMS implementations cost 15x more than advertised, and that's why life sciences organizations are experiencing a dramatic shift in how they approach quality management software. ...
The Complete Guide to Pharmaceutical Compliance Software
Pharmaceutical companies operate under some of the most complex and demanding regulatory frameworks in the world. Whether you're preparing for an FDA inspection, managing a multi-country...
What Healthcare Needs From A Quality Management System
The pressure on healthcare organizations to deliver safe, effective, and compliant care keeps growing.
The Complete Guide To Correspondence Management In Life Sciences
In life sciences, it's easy to overlook correspondence. Between protocols, submissions, validation plans, and controlled documents, emails and message threads can feel like background...
Regulatory Document Management Systems Explained
SOP drift. Duplicate files. Missed periodic reviews. Failed audits. These are all symptoms of a document management process that isn't built for regulatory rigor.
Beyond Compliance: Building a Smarter SOP Management System for Pharma
Standard Operating Procedures (SOPs) are the spine of any pharmaceutical quality system.
In an industry where a single misstep can mean the difference between life and death, there's no...
Three MasterControl QMS Alternatives For Growing Quality Teams
If you're looking for a MasterControl alternative, you might be looking to cut costs due to uncertain market conditions, or you might be part of a growing quality team that is looking for a...