A few years back, it was common practice to manage all regulatory and quality documentation on windows explorer and update a printed copy of the company’s procedure set and DHF when an update was deemed required (submission, audit, periodical alignment). This outdated method is of course very challenging to maintain, full of technical human errors and a big waste of paper. Many small companies still manage their documentation on windows explorer without holding a printed copy. This method is still acceptable in many audits but is not in compliance with document control requirements (Per ISO 13485 or FDA 21 CFR Part 11).
“ORCANOS | MEDICAL is helping us achieve the higher quality we aspire to reach and load of our mind..”
Ofer Levy Senior Manager, at QSite
“ORCANOS is really helping us increasingly manage very complex tasks.
“Enabling us to work whenever the customer needs us around the world.”
“Helps us maintain our customer’s documents ready for audit and anytime.”
QMS Tool Selection Process
I have been searching for a long time for a tool to manage quality and regulatory documentation. A tool that I could offer my customers with no capital investment or a big financial commitment in deployment and annual fees. A cloud-based solution was very important for QSite it allows us to have a remote access to the documents in a simple way.
I came across Orcanos in a conference I was attending and started to discuss with them my requirement. They introduced Qpack and the simplicity of starting to use it.
“A web-centric tool that allows collaboration with other parties, distributors around the world”<
“Unified approach creates more agility”
Orcanos QPack ALM is used quite substantially across the company organization, for the following disciplines:
- Document Control
- Electronics Forms
- SOP Management
ORCANOS | QMS provides all the document control features I was looking for and many other options that I have not fully taken advantage of yet.