Showing posts tagged with: document control

It takes the same amount of time and effort to create a good quality manual as it does a bad one. Oftentimes, far less... In this article, we will discuss how to establish, operate and maintain a good one: Introduction (what is a QM, and what should include) Common mistakes in establishing a QM, and how to avoid them Pro...

When I say Validation For Intended Use, most of you picture an extensive documentation required by ISO and FDA. Although Validation for intended use documentation is useful for several reasons (ensure accuracy, reliability, consistent intended performance, the ability to discern invalid or altered records, etc.) people mainly think of it as a regulatory requirement only. In FDA's...

Issues in approval workflows Achieving and maintaining compliance is not an easy job as both ISO and FDA regulations require that documents be approved before they are officially distributed or used either inside or outside the company. Obtaining approval from a group of people for a project plan, a proposal, or any other required document can...

Whether you are freshly minted into the QMS position or you are a founder of a Startup or a product manager with a new project… your strategy requires QMS oversight. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.   A properly designed Document Control and Management Chasing document traceability can...

The QMS documentation – especially for a complex project – can be endless and impenetrable. All of us are familiar with the pain of trying to make order out of complete file chaos, or the vain hope of finding a particular document in a pile of paperwork, be it old-school paper-based or modern electronic software...

Whether you are freshly minted into the QMS position or you are a founder of a Startup or a product manager with a new project… your strategy requires QMS oversight. QMS Joe will guide you with handy tips & tricks to streamline your way to compliance.   So, what documentation hierarchy should we adopt? This question is a...

  The newbie QMS Managers Conundrum – 5 things to identify the right Expert? As a newly minted QMS manager in a medical device startup, I turned to the internet for what to do. Soon I had to realize that today everybody is an internet certified QMS expert. There was information galore, in fact so much information...

QMS, another layer of management or smart management.  If you’re thinking that a QMS system would be just another layer of management, think again! It’s true that most QMS systems are form-driven. Do an action, fill-a-form. Make a meeting, fill-a-form? The list is endless and if you forget, which is easy to do when deadlines are knocking...

Successful startups and small businesses understand that although a DMS (Document Management Software) is essential to success it is outright critical for compliance. The top features requested in DM software reflect the growing needs of Startups and Small companies who cannot ignore the increasingly central role a DMS plays in their growth and success – both...