FAQ | SOLABS | EQMS Software

FAQ

Why does SOLABS refer to Processes instead of Workflows, and what are these processes in SOLABS QM?

Processes in SOLABS QM can be seen as a form of sophisticated workflows allowing people to process and circulate e-forms among individuals almost as if it was a paper form. Fortunately though, e-forms cannot be lost and require less foot-work to move from one person to the next…
Processes enforce compliance since users must always follow certain steps to complete a process. A flowchart corresponds to each process deployed in SOLABS QM. A formal sign-off is required when completing a process step e.g. “QA Sign-off” or “Change Control Initiation”.
Other forms of workflows exist in SOLABS QM e.g. “Document Approval and Review Cycles”.

Please describe the profile of a standard person or organization considering to buy SOLABS QM?

You should consider evaluating SOLABS QM as a QMS software if :
– You need better control on documents and processes such as CAPA, Deviation, Change Control;
– You have limited resources in the Quality and IT departments;
– You are looking for a supplier who actively supports the implementation process i.e. by taking off some of the validation effort off your shoulders, managing the project, etc..
– You want to make sure that once in operation, your QMS software is easy to operate within your organization.

Please describe a typical client using SOLABS QM?

SOLABS targets mid-size (tier-2) organizations and subsidiaries of large organizations who are regulated by the Therapeutic Products Directorate (TPD) in Canada or the Food and Drug Administration (FDA) in America.
Clients choosing SOLABS QM generally have limited resources in the Quality and IT departments but consider that a QMS software will bring a competitive advantage to their organization by improving productivity and minimizing non compliance risk.

How flexible is SOLABS QM?

SOLABS QM provides an out-of-the-box approach for dealing with quality processes (Change Control, CAPA, Deviations, OOS, QAIs, etc.) and controlled documents.

However processes deployed in SOLABS QM e.g. CAPA can be customized to fit with your actual SOPs and forms. If you can explain it, SOLABS can make it happen!
Please ask for a Live Demo ( info@solabs.com) and we’ll gladly introduce SOLABS QM directly at your desk (using Webex and Teleconference).

How do I access SOLABS QM as an end user?

SOLABS is a Web-based software system so it can be accessed from any workstation having network access to the system using a Web Browser.

Can you describe the main functions of an electronic quality management software system?

Any QMS software should have the following functions:
1. Allowing quality system processes to become live business processes where Change Control forms for instance circulate electronically among many individuals.
2. Managing controlled documents and their life cycle (draft, review, approve, publish when effective, supersede with a new version, and retire).
3. Documenting employees’ training records electronically.

Can you configure processes (e.g. Change Control or CAPA) according to my organizations' SOPs?

Process can be configured to respect your SOPs and Forms 100%. You do not need to adapt to SOLABS QM, it adapts to you.
SOLABS is setup to deliver a quality system that will work 100% for you but obviously we do not re-invent the wheel each time, we provide clients with process templates, process examples, and best practice approaches to Equipment CC, Process CC, Document CC, Other CC, CAPA, OOS, Third Party OOS, Deviations, Non-Conformances, Complaints, and more. We also have developed IT-related controlled processes such as System Access and IT Change Control.