What Healthcare Needs From A Quality Management System
The pressure on healthcare organizations to deliver safe, effective, and compliant care keeps growing.
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...
The 7 Best Quality Management Systems (QMS) For Life Sciences
In regulated industries like pharma and MedTech, a Quality Management System (QMS) needs to do a lot more than check off a compliance checklist.
How To Choose The Right CAPA Management Software For Life Sciences
Corrective and Preventive Action (CAPA) processes are essential for any life sciences organization aiming to maintain product quality and regulatory compliance.
Unique Challenges & Solutions For Combination Product Development
Combination products represent some of the most innovative therapies in life sciences, but they're also some of the most complex to develop, manufacture, and bring to market.
How to Build a Strong Vendor Management Audit Program
Vendor oversight is a regulatory requirement that comes with some tough challenges.
Quality Events In Life Sciences, Explained
Quality events in life sciences aren’t just routine compliance tasks.
They’re pivotal moments, and when they're handled well, they can accelerate development and build trust. Handled...
All About 21 CFR Part 11 Compliance
What is 21 CFR Part 11?
21 CFR Part 11 is a regulation established by the U.S. Food and Drug Administration (FDA) that sets the criteria for electronic records and electronic signatures...
The Future of eQMS: How Automation is Changing Compliance and Quality
As regulatory requirements become increasingly stringent in the pharmaceutical and medical device industries, companies must adopt efficient, scalable, and compliant solutions to manage...
What's Good in QC? Understanding Quality Control and Compliance Standards: GQC, GMP, GLP, GCP, and GDP
Maintaining high standards of quality and safety in life sciences industries is essential. Several globally recognized quality management systems have been established to ensure...