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Showing posts tagged with: document management

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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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The Quality Manual Alias the Quality Bible or the Quality DNA

The Quality Manual Alias the Quality Bible or the Quality DNA

  Document what you do and do what you document Quality Manual is the foundation and framework from where you build your organization. It is a plan, which sets the direction and navigates the organization within the defined parameters. Like any plan, it is good to revisit once in a while and check against the agreed objectives,...
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Do you know how secure your documents really are?

Do you know how secure your documents really are?

Data loss or damage is costly, extremely risky and can affect your brand reputation. Perils might come in many forms, as natural disaster (e.g.  hurricanes, floods, fire) or uncontrollable human errors, power surges, technical malfunctions and increasingly malware attacks. You need a backup plan and the ability to restore your data quickly. While data loss may...
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Weekly Cup of Joe #25– Documenting Opportunities to Improve

Weekly Cup of Joe #25– Documenting Opportunities to Improve

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. MS Joe will guide you with handy tips & tricks to streamline your way to compliance.   The Relation Between Risk Assessment and Opportunities to Improve Companies often fail to...
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Weekly Cup of Joe #21 – References on Obsolete QMS Documents

Weekly Cup of Joe #21 – References on Obsolete QMS Documents

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.   The importance of identifying and updating all the documents that...
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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 #17 –Don’t Buy Pig in a Poke!

Weekly Cup of Joe #17 –Don’t Buy Pig in a Poke!

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.   Approving Documents with One Click Obtaining approval from a group...
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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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QMS documentation - “What should I document?”

QMS documentation - “What should I document?”

Good QMS documentation is essential for an effective quality management system. Properly structured documentation will make your operations much easier, while incorrect documentation will bring you nothing but trouble. Use qmsWrapper to structure your QMS documentation, follow the necessary steps and avoid those unpleasant last minute surprises.    What has to be included in a QMS Documentation, regarding...
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Weekly Cup of Joe #14 – QMS Documentation

Weekly Cup of Joe #14 – QMS Documentation

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.     How to put together a QMS documentation successfully? Properly structured...
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QMS for Beginners – A quick guide on where to Start ! …Part 3

QMS for Beginners – A quick guide on where to Start ! …Part 3

  The 13 items that will guide you through the implementation of QMS ...Let's pick up where we left off !   8. Selecting the right system to support your Compliance Compliance Solutions are essentially QMS based solutions. They come in all shapes and sizes. Some solutions, such as ZenQMS are nothing more than forms tacked on to a project management...
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QMS for Beginners – A quick guide on where to Start ! …Part 2

QMS for Beginners – A quick guide on where to Start ! …Part 2

  The 13 items that will guide you through the implementation of QMS - continues...   4. Organizing the work Next you will need to define the flow of how work gets done within your organization, i.e. the workflows. Why, because you need to understand where compliance issues will fit in. Workflows can show you the path tasks take through your organization… i.e....
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Project management and quality management 2017 - smart solution

Project management and quality management 2017 - smart solution

qmsWrapper is 1 system with 5 modules   and if you thought project management couldn't include QMS... think again...    In a global environment, companies are facing countless complex and unique industry challenges. Quality becomes not just a buzzword but a true competitive advantage – companies that deliver the best quality products and services efficiently - succeed. Today’s QMS and...
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Weekly Cup of Joe #9 – Improper document, wrong results

Weekly Cup of Joe #9 – Improper document, wrong results

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 is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to...
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The Dawn of Integrated QMS… Part 2

The Dawn of Integrated QMS… Part 2

qmsWrapper, the leading integrated QMS system specifically aimed at compliance  qmsWrapper has Compliance in its DNA. Since developed by a medical device company, the priority was to design a QMS application that solves many challenges facing medical device startups and small companies. Based on Project, Quality, Risk, and Document Management with a truly comprehensive Team messaging. In qmsWrapper,...
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The Dawn of Integrated QMS… Part 1

The Dawn of Integrated QMS… Part 1

Making the life of a startup easier As regulatory and standards compliance increasingly play a critical role in business success, integrated compliance tools remain a sore point. QMS systems are too often based on PDF documents being generated at the right time. The challenge for the user is knowing when that time is, and what form...
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Top Documentation Pain Points Solved With DM Software

Top Documentation Pain Points Solved With DM Software

Today’s businesses are up against more challenges than ever in the past. While some businesses think they don’t need to move away from paper, getting started with this practice has never been so crucial. Document management software makes it easy for businesses to combine paper and digital files into a single hub, as physical documents. Companies...
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Weekly cup of Joe #2 - Documenting Compliance

Weekly cup of Joe #2 - Documenting Compliance

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. qmsJoe is here to guide you through the plethora of information and support you with handy tips & tricks to streamline your way to compliance. Simply...
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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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6 reasons why DM System makes a difference

6 reasons why DM System makes a difference

In today’s modern world there is no space for time wasting. The challenge of time was best expressed by William Penn when he said, “Time is what we want most, but what we use worst”.  Managing time in a fast growing business world, requires serious sets of skills. The new generation of Document Management Software offer...
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