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Showing posts tagged with: document control

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Pitfalls and Best Practices in Establishing a Quality Manual

Pitfalls and Best Practices in Establishing a Quality Manual

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 it include) Common mistakes in establishing a QM, and how to...
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Validating or Not Validating for Intended Use?

Validating or Not Validating for Intended Use?

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...
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Approval Workflows in QMS

Approval Workflows in QMS

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 be a frustrating...
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Weekly Cup of Joe #16 – Document Search Requirements in the QMS

Weekly Cup of Joe #16 – Document Search Requirements in the QMS

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...
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Documents in a Paperless Office, Find a Needle in the Haystack

Documents in a Paperless Office, Find a Needle in the Haystack

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...
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Management Through Quality, documenting compliance activities

Management Through Quality, documenting compliance activities

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...
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Top 13 plus 1 requested features in a DM Software

Top 13 plus 1 requested features in a DM Software

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...
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