CONFIGURABLE QUALITY MANAGEMENT & COMPLIANCE SOLUTIONS
BUILT ON A VALIDATED PLATFORM ACCORDING TO FDA REGULATIONS
FOR LIFE-CHANGING INDUSTRIES
Configurable on the Cloud QMS that adapts to your processes and boosts efficiancies. Validated according to FDA regulation and computer System validation guidelines. Stay in Compliance & Move Comfortably into the Future.
Cloudtheapp is a Cloud Based Validated Regulatory Compliance Configurable Platform & Solutions.
Cloud Based: “SaaS” so we and Amazon AWS take care of Infrastructure, security updates, maintenance, and everything in between.
Validated: our platform is fully validated according to FDA Computer System Validation Guidelines and Good Documentation Practices (GDP). We have a full validation package for every platform update, that you can leverage, containing all needed documents and artifacts to help you comply, like Validation Plan, Test Plan, IQ, URS, OQs, PQs, Traceability Matrix, Summary Report and more.
Regulatory: we built everything with FDA 21CFR part 820, Life Sciences cGMP, ISO 13485, ISO 9001, and ISO 22001 needs in mind.
Configurable: we have done all the coding and you just drag & drop using our easy to use graphical interface to configure and build modules.
Watch a 5-minute
Creating advanced configurations without any scripting or code is a simple task with our rule wizard. It allows you to configure basic or complex rules using a graphical interface. The rules can be set to trigger on opening/moving/saving records. You can setup validation rules, automatic creation of records, inheritance of values across forms/records, and automatically move records to the next step. You can optionally apply conditional logic with if/then actions, based on checking the step, field values, whether a field is empty. There are dozens of possible conditions and actions for nearly every need and we are adding more all the time.
Our platform is cloud native. Designed for the cloud from inception to ensure unlimited scalability and optimum performance. We leveraged Amazon AWS, the proven leading cloud infrastructure, to guarantee dependability and peace of mind.
We have the features Life Science companies need and have come to expect; such as field history (Audit Trail), transaction history tracking, electronic signatures (e-sig), forced authentication (on routing a record or saving it), and much more.
PaaS / SaaS
We are a 100% SaaS company with multitenant architecture. This means your system will be up and ready to use seconds after signup, giving instantaneous time to value. Internet access and a standard browser is all that is needed client-side so there is nothing to install. SaaS reduces your IT costs and headaches. Enjoy frequent updates (both system and app specific) at no additional cost. Signup is subscription based with credit card payment. Your system will be up seconds after signup. Multi-tenant simplifies working with suppliers and other external parties without having to manage the extended security if you were to give them access to your network.
Our App Store has many apps (both free and paid) ready to deploy with the click of a button, including a full EQMS suite. You decide what to deploy to minimize clutter and avoid confusing your users with modules they don’t use. You can use the module as is, or customize every detail of the design. You can also optionally upload new or modified modules you designed to our store for other companies to use.
Create unlimited isolated stages (dev, qa, prod etc…) to hold your modules within few seconds. For instance you can design the module initially in a dev stage, then test it in a qa stage, and only go to production when ready. Transfering modules from one stage to another is a 5 second process simply by clicking on the app, then selecting which stage to copy it to.
Enterprise Quality Management System
ISO 9001 | ISO 13485
Our EQMS was built by a team of experts that possess over three decades of industry experience. The main goal was to come up with an Enterprise QMS and Compliance Solutions that remedy all pitfalls of other competing systems. We made collaborating with suppliers, auditors, consumers, or any other external party possible and instant, unlike other systems where you have to have additional disintegrated systems installed or use tedious back and forth emails. Our EQMS builders allow you extend usage of the ready-made applications to build and automate all of your other processes and have them all integrate with each other in hours and without having to write a single line of code.
Some of Our Customers
what our customers say
If you can dream it, you can do it, with Cloudtheapp!
INDUSTRIES WE SERVE
Built for life-changing industries
recent posted blog
Cloudtheapp is delighted to publicize the release of our renovated Regulatory Dossiers and Submissions Module, allowing businesses to digitalize regulatory processes around establishing dossiers of documents to comply with regulations, and to track submissions to relevant agencies and regulatory bodies…
Cloudtheapp is delighted to announce the release of our Engineering Change Module…
Cloudtheapp is pleased to announce the release of our Out-of-Specification Module, allowing businesses to digitalize this important quality control process.