Here at, Advena Medical Ltd, we firmly believe that a smooth transition to a digital – paperless document workflow can set up an organisation for success, which is why we’ve developed an in-depth QMS System called ACTIV to assist our partners as they make the switch.
We have noticed that more and more organisations are switching to digital document workflows from traditional paper-based processes to improve document accessibility, security, and storage.
What are you waiting for?
There is still a large school of thought that still see the QMS as a regulatory nightmare and hindrance rather than a management tool for efficiency and productivity.
In particular the problems are intensified where there are;
- A large numbers of documents.
- Multiple sites using the same procedures.
- Remote workers.
As a consultancy we see all these problems, many first hand, as we don’t just set up quality systems for clients but actually run the document control for them from our Warwick office using the web-based ACTIV QMS system that is licensed for us to supply to the medical device industry.
ACTIV is a web-based QMS software package which can be accessed from any PC with internet access, around the world and enables you to electronically control:-
- All your quality documents and records via a strict electronic change control process
- Supplier/sub-contractor status, tracking audits, certification
- CAPA’s to track actions and implement improvements
- Customer Complaints to track progress
- Customers status
- Customer Feedback to enable you to send out questionnaires to clients in order to receive feedback as part of your post market surveillance.
Our experience has shown that the ACTIV web based QMS provides;
- A system suitable for the smallest of organisations.
- Dramatically improved system effectiveness, ease of implementation and management.
- A process easy to convert to from any existing document system.
- Easy QMS compliance from any computer connected to the web and suitable for multiple sites using the same procedures anywhere in the world with web access.
- A straight forward document & record control with automatic change control and the storing of obsolete documents.
- Easy and automatic control of continual improvement (complaints, non-conformity, audits).
- Easy customer feedback (post market surveillance), supplier control and communication.
- The option of single controlled access point (administrator) with alternate multiple other users with lower access level or just read only. Each user, with a secure log-in, could be anywhere in the world.
- Readily available and instant management information.
- Readily available specifications, drawings, procedures, forms, records, guidelines, general information to all, and all paper-less.
- An easy to operate process (training can be provided) or can be administered by a third party (such as us) remotely from the main site. Could also be audited by a Notified Body remotely from the site; a very important advantage
- Measurable cost effectiveness.
- Established processes currently used successfully for very many small to medium sized companies in Europe
Most modules enable results to be statistically analysed to produce graphs or tables (something auditors love to see).
Once set-up with the data on the processes and procedures used, and approved suppliers / sub-contractors are listed, an operator of the system just needs to be party to the purchasing, manufacturing and dispatch records, (including traceability) to keep it up-to-date.
If you are interested we would be more than happy to provide you with a free log-in to our Advena ‘demo system’ which will provide you with an idea of what the system looks like as well as enabling you to experience some of its benefits.
Contact firstname.lastname@example.org for costs and more information.