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Frequently Asked Questions (FAQs) about ColabON Compliance Solution

Why do I need this software?

Your company records and manages more data than ever before. Demands on your team are tightly regulated, with the obligation to do more with the utmost accuracy, speed and conformity. There is no room for error; everything must be transparent and auditable. Recruiting qualified and capable people is difficult and costly… if it is even an option.

ColabON provides a single quality management software system that removes duplication and redundancy in your processes. There’s no need to manually transfer information between different systems because your processes are all integrated.  That allows your staff to work more efficiently.

How is this different to what I could get elsewhere?

Most companies’ Quality Management relies on an ERP system supported by manually controlled documents and spreadsheets. ERP is outdated technology.  It’s expensive to buy, slow and costly to run. How often have you tried to interrogate the system and you then have to ‘translate’ the output into a useful and usable format? That unnecessary step wastes your time and hinders your innovation process.

ColabON is not a proprietary database. It is designed and built to give you the outputs you want, in the format you require, when you need them.

What if the system went down? Could my data and records be lost?

ColabON is hosted securely in Switzerland by Google Cloud. For maximum security, data is hosted on multiple servers and backed up in real time. You also have the option to host on your own servers, if you prefer. Our cyber security meets the highest international standards, and we are happy to provide you with more information to reassure you that everything you entrust to us is safe.

What about audits? Could we be confident to show this to an auditor?

We’ve worked with ISO 13485, 21 CFR, CAPA and similar systems all our working lives! We built our software with audits in mind. Not only does ColabON automatically generate system documentation, it also maintains the information you need for internal and external auditing as well as the audit records themselves. The simple, user-friendly environment makes it easy and secure for an auditor to find and view the evidence they need. And, because we have 24 hour support, you can rely on us to help if necessary during an audit.

I already have an IT department to support my organisation. How do they fit in?

We work with your IT team to make sure that ColabON software integrates with your IT system as a whole. Every client organisation is different – from size to IT expertise. We work with you to make ColabON work for you.

Regulations and Standards are always changing. Can you help me keep our system up to date?

When new standards and regulations are released, we integrate the updates and changes into our software. You automatically get a clear gap analysis for your system, in everyday language, without having to dredge through the published requirements.

You then take control of what you need to change and when, generating traceable, timed tasks for document and process owners.

We’re a small company with no dedicated IT function. How do we keep ColabON up to date?

With proprietary systems, development and release happens over months at a time. Our decision to release incrementally every 2 weeks is a response to the needs of our customers, steered by the priorities they identify at our co-development think tank. Because it’s a SaaS subscription, your software is always up to date. We take care of that, with no action from you.

This incremental co-development approach has several advantages for you. Firstly, every release is checked for stability in a test environment before it goes live. Secondly, you get faster access to new functionality. Lastly, users adapt easily to smaller incremental changes, so there’s no need to retrain users once they are already confident with the software.

Does ColabON support us with updating and locally validating things like standard operating procedures (SOPs) and work instructions?

Because ColabON is a content management system and not document management, everything that belongs together is managed together in one place. Real efficiencies come when you assign ownership of responsibilities, procedures and documents in a system that recognises that ownership and notifies the right people at the right time.

When content changes, related task, procedure and document owners are notified. There is never any doubt about what content has been updated, validated or released. And, by integrating your training, the release of new content will immediately flag who needs to be trained or updated, with a traceable record for audits.

Learn more about our computer system validation here.

Have you got a question we haven’t answered?