Curing Document Control Conundrums: A Checklist for Sustained Efficiency and Audit Readiness

    Effective document control software systems give companies the ability to readily track and review document revision and approval his...

Big Changes for ICH GCP & EU Regulations

Changes are being proposed for international  clinical research, including the European Union.   How and when will they affect your work? by...

Inspection Readiness: Leveraging Inspection Focus Areas and Increasing the Transparency of Investigator Oversight

An auditor's goal is to confirm the trial runs  in a way that ensures the safety of the subjects,  protects their rights and generates r...

EDMS Evolution: Automated Document Management as a Differentiator

Companies are now  spending more on automating  document management than any other quality process.  How advanced is your DMS technology? by...

Why a Zombie Apocalypse Would Be Unstoppable with a QMS

Would zombies be more successful  at world domination if they used an  electronic quality management system? by Marci Crane Localization Man...

Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

Preparing for an inspection will help ensure a smoother,  less stressful experience. A mock inspection is a useful practice tool. by Kelly T...

4 Reasons Why Document Review is Crucial to Compliance

When was the last time you reviewed  your quality documents? by Cindy Fazzi Editor, MasterControl Insider When was the last time you reviewe...

Tales from the Front

Sometimes it’s your company that forces  a new direction during the inspection,  sometimes it the auditor. Sometimes it’s both. Adventures o...

5 Tips for Winning Executive Buy-In for a New QMS

These five strategies will help convince  the executives and departments in your  organization to support your proposal f or a  new EQMS or ...

Regulatory Affairs & Regulatory Operations: The Air Traffic Control Tower of Life Sciences

Is your job in regulatory operations  similar to that of a control tower operator? by Patricia Santos-Serrao  MasterControl's Market Seg...

Four Reasons to Automate SOP Management in FDA and ISO Environments

In FDA and ISO environments,there are multiple  reasons to consider automating SOP management. by David R. Butcher,  Marketing Communication...

7 Document Management Blunders that Jeopardize Compliance

Is bad document management spoiling  your compliance efforts? Learn how  to fix seven common document  management mistakes. by James Jardine...

CAPA Should Not Be a Dreaded Four-Letter Word

A poorly maintained paper-based CAPA  process may contribute to FDA violations. by Cindy Fazzi Editor, MasterControl Insider In a regulated ...

Risk Management: A Primer for Lean Quality Assurance

Managing risk across an organization is now a critical skill  that should be fully integrated with other business functions  such as financ...