SOLABS Blog | Quality Management Systems Insights & News

Blog & News

SOLABS Customer Support & Software Product Release

Q&A with SOLABS’ Product Release Manager

EQMS - 12.07.2016

By Martha Bailey, Product Release Manager, SOLABS As part of our monthly SOLABS technology blog series, we’re speaking with our developers and analysts on their reflections on the industry, its development and rapid changes, and how their area of current focus may be pertinent to compliance/regulatory and the future of Enterprise...

Product Specialist Role

EQMS - 11.22.2016

By Daniel Cadoch, Product Specialist, SOLABS The Product Specialist role is a multi-faceted one within any organization, let alone an already-specialized software company. Product Specialists are both technical (in that they are tasked with knowing their product inside and out), as well as sales-oriented. The role is, in essence, the...

Optimizing SOLABS Quality Management System for the Life Sciences

Optimizing SOLABS QM Core Software Performance

EQMS - 11.16.2016

By David Abran-Côté, Software Developer, SOLABS As part of our monthly SOLABS technology blog series, we’re speaking with our developers and analysts on their reflections on the industry, its development and rapid changes, and how their area of current focus may be pertinent to compliance/regulatory and the future of Enterprise...

Quality Culture: Internal & external messaging

Creating & Sustaining a Quality Culture: Part 3 – Internal & External Messaging

Quality Management - 11.09.2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit In previous discussion, we've looked at the importance of demonstrating the quality commitment of the organization in our day-to-day actions, and various ways to create an impactful quality message. To conclude this topic, I’d like to discuss ways to...

Montreal Job Posting System Administrator

Job Posting: System Administrator

Job Postings - 11.08.2016

Job Description Title: System Administrator Status: Permanent, 40 hours per week Salary: To be discussed City: Montreal (Old-Montreal), 15 minutes from Square-Victoria métro station About SOLABS SOLABS was founded in Montreal over 15 years ago. The company has offices in both Canada and the United...

Quality Culture for Pharma, Biotech, Medical Device and R&D

Creating & Sustaining a Quality Culture: Part 2 – Making an Impact

Quality Management - 10.26.2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit There are many ways that we can reinforce the quality culture of an organization. To illustrate this point, I’d like to share an example from my career: During a visit from a major customer, I was accompanying a tour of the manufacturing facility....

Life Sciences Quality Culture on Target

Creating & Sustaining a Quality Culture: Part 1 – Living the Values

Quality Management - 10.05.2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit There are two important elements to effective communication in the workplace: the content to be communicated, and the demonstration of that content. If a policy change is communicated, then leaders of the organization, both managers and the informal...

Creating a Quality Culture in Pharma, Biotech and Clinical Trials Companies

Creating & Sustaining a Quality Culture: Introduction

Quality Management - 09.21.2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit In July 2015, the U.S. Food & Drug Administration (FDA) published the Draft Guidance for Industry entitled, Request for Quality Metrics, requesting public comment on whether to give establishments the opportunity to submit additional, optional metrics...

Head of SOLABS' Quality & Best Practices Unit - Tips for Communicating with FDA, EMA or Health Canada Auditors

5 Tips for Communicating with Auditors

Audits - 09.07.2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit The best organizations look at audits as an opportunity to showcase their operations, and recognize that good audits are invaluable in emphasizing the importance of compliance to management and staff. A crucial aspect in relating to auditors is sticking...

Preparing for an FDA Audit

Preparing for an Audit

Audits - 08.24.2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit Some people might consider a Quality audit of their facility as an aggravating ordeal--a time to grit one’s teeth and suffer through endless questioning and review. The best organizations, however, view good audits as an opportunity to both showcase...

SOLABS Quality Business Processes- Audits, CAPA, Change Control, Investigations

QM APPS: Quality Business Processes & Report Configuration

Quality Business Processes - 07.27.2016

By Francis Lau, System Analyst, SOLABS As part of our monthly SOLABS technology blog series, we’re speaking with our developers and analysts on their reflections on the industry, its development and rapid changes, and how their area of current focus may be pertinent to compliance/regulatory and the future of Enterprise Quality...

Head of SOLABS' Quality & Best Practices Unit - Tips for Communicating with FDA, EMA or Health Canada Auditors

Handling Customer Product Complaints

Complaints - 07.13.2016

By Brian Graeff, Head of the Quality & Best Practices Unit, SOLABS The quality process for handling customer complaints is unique in many ways. First, it is the only quality process that interacts directly with the customer. Company representatives frequently communicate directly with pharmacists, nurses, doctors or the patients to...

Reports & Metrics in Life Sciences

How Optimizing Access to Reports & Detailed Metrics Maximizes ROI

Reports & Metrics - 06.29.2016

By Anne-Marie Pinet, System Analyst, SOLABS As part of our monthly SOLABS technology blog series, we’re speaking with our developers and analysts on their reflections on the industry, its development and rapid changes, and how their area of current focus may be pertinent to compliance/regulatory and the future of Enterprise Quality...

SOLABS Quality Business Processes- Audits, CAPA, Change Control, Investigations

QM APPS Business Process Engine

Quality Business Processes - 06.15.2016

By Diem Le, QM APPS Lead Developer, SOLABS For the second instalment of this two-part interview, we’re talking with SOLABS QM APPS Lead Developer Diem Le, whose current work finds her collaborating closely with a Development team engineering QM APPS, the powerful, lean and intuitive automated business Processes that can be used by...

Quality Management System Software User Group Meeting 2016- SOLABS

Building SOLABS’ User Community: Part II

SOLABS Community - 06.01.2016

Every year for the past several years, SOLABS has hosted a User Group Meeting (UGM), both as an educational and social gathering and for users to get the pulse of their industry peers and Quality in general. SOLABS’ Director of Sales and Marketing Ericka Moore sat down to speak with us recently about the 2016 edition of the UGM, and to...

SOLABS Quality Management System (QMS) User Group Meeting 2016 Presenters

Building SOLABS’ User Community & the SOLABS QM User Group Meeting

SOLABS Community - 05.18.2016

Every year for the past several years, we've hosted the SOLABS QM User Group Meeting (UGM), both as a learning and social gathering and for users to get the pulse of their Life Sciences industry peers and Quality in general. SOLABS’ Director of Sales and Marketing Ericka Moore sat down to speak with us recently about the 2016 edition...

SOLABS Quality Business Processes- Audits, CAPA, Change Control, Investigations

QM APPS Development: CAPA, Investigation, Quality Events, Audits & Change Control

Quality Business Processes - 05.11.2016

By Diem Le, QM APPS Lead Developer, SOLABS As part of our monthly SOLABS technology blog series, we’re speaking with our software engineers on their reflections on the industry, its development and rapid changes, and how their area of current focus may be pertinent to compliance/regulatory and the future of Enterprise Quality...

Corrective & Preventive Action (CAPA) Bridges

Does Your CAPA Process Need a CAPA?

Corrective & Preventive Action - 04.27.2016

By Brian Graeff, Head of the Quality Best Practices Unit, SOLABS I have had the opportunity and privilege to work in the pharmaceutical industry for the entirety of my professional career, which spans several decades. I came into the industry while 'Testing Quality in' was the norm. I have seen and worked through the development of...

Quality Management System (QMS) Data Migration for Pharma, Biotech & Medical Devices

Data Migration & Scripting for Regulated Environments

Information Technology (IT) - 04.13.2016

By Antonio Hernández, Software Developer and Analyst, SOLABS As part of our monthly SOLABS technology blog series, we’re speaking with our software engineers on their reflections on the industry, its development and rapid changes, and how their area of current focus may be pertinent to compliance/regulatory and the future of EQMS...

Periodic Reviews Controlled Documents

Document Control & Change Control: Periodic Reviews & Retraining

Document Control - 03.16.2016

By Philippe Gaudreau, Founder & CEO of SOLABS Our previous blog in the Document Control Series covered the various and incremental ways companies choose to do document reviews and change control, and the strengths, weaknesses and future predictions for the evolution of each; This blog discusses our current thinking, as it has...