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Your one-stop-shop for regulatory, clinical, and quality insights, from whitepapers to webinars to how to guides. 

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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. ...

15 July 2025
13 min read

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...

15 July 2025
10 min read

What Healthcare Needs From A Quality Management System

The pressure on healthcare organizations to deliver safe, effective, and compliant care keeps growing.

12 July 2025
8 min read

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.

1 July 2025
8 min read

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...

30 June 2025
14 min read

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...

26 June 2025
8 min read

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.

13 June 2025
7 min read

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.

12 June 2025
6 min read

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.

11 June 2025
7 min read

How to Build a Strong Vendor Management Audit Program

Vendor oversight is a regulatory requirement that comes with some tough challenges.

27 May 2025
7 min read

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...

22 May 2025
6 min read

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...

22 April 2025
6 min read