Showing posts tagged with: document management

Maybe it’s doesn’t make a big difference, but it does actually! Based also on many requests of our clients, here it is.   qmsWrapper File App The Wrapper File App was developed to make file/document editing easier and safer. It saves time and makes your job much simpler. With this app, at least two redundant steps are taken...

Every company has as part of its organization set of procedures and processes. The purpose of having procedures is to drive efficiencies towards fewer errors and resulting reworks, which can improve cost saving. Besides that, their purpose is also to make sure they are in compliance with regulations. The procedure is correct, but are the follow-ups? But...

It's one thing to become ISO certified, but maintaining the certification is another thing with all the updates and new records. Besides following the processes and procedures that were set, it's also required to improve processes and all recorded as evidence. That means keeping up with your documentation, updating procedures when the processes change, modify work...

One of the main criteria for an eQMS is to have implemented an electronic signature. Much eQMS software have found many ways to handle this issue, but they all have to satisfy 21 CFR part 11. This part clearly paraphrases the fundamental rules of electronic signature implementation and control for compliance needs. When we are talking about...

Most of the startups and small companies have a problem with organizing folders, especially if they are still using a paper-based QMS. Where is this file? Is it under review? Is this draft version? Is it approved? The need to check it and review it, then approve can take time and mistakes can be weird...

One of the main fears when transferring from paper-based to eQMS is how to handle a lot of file versions, how should we name them, should we import every single version? You just need to upload the latest version without the number of that version (for example “Technical file”) and make a note in the file...

  Traceability is required by regulations. Traceability Matrix Updated 2019, For FDA, 510(k), DeNovo or PMA, traceability is required as part of your Design History File (DHF). Soup to nuts, they expect you to demonstrate how it is all connected, where and how requirements were met. For the CE mark, the requirements are similar, if not the same! Failure to...

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...

  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,...

Data loss or damage is costly, extremely risky and can affect your brand reputation. Perils might come in many forms, as natural disasters (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. Warning steps through infographics While...

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...

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...

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.   Approving Documents with One Click Obtaining approval from a group...

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...

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 ISO? Usually,...

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...

  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...

  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....

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...

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...

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,...

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...

  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...