SOLABS Blog | Quality Management Systems Insights & News

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Xconomy Awards Biotech Week - Commitment to Diversity

SOLABS Named Commitment to Diversity Award Finalist

Industry News - 08.10.2017

The 2017 Xconomy Awards Recognize the Best of the Boston/New England Life Sciences Industry BOSTON, MA — SOLABS, a software company that develops Electronic Quality Management Systems (EQMS) for the Life Science industry, has been named a Commitment to Diversity Award finalist in the 2017 Xconomy Awards. “It is a great...

Medical Software Company of the Year

SOLABS Named Medical Software Company of the Year by CorporateLiveWire

Industry News - 08.03.2017

Enterprise Quality Management System (EQMS) Company Receives 2nd Prestigious Award in Past 12 Months BOSTON, MA — SOLABS, a company that develops Electronic Quality Management System (EQMS) software for the Life Science industry, announced today that they have been named Medical Software Company of the Year – USA in the 2017...

Automating Quality Operations in the Biotech, Pharma, Medical Device, R&D and Clinical Trial industry

Who Says Automating Quality Operations Isn’t Sexy?

Quality Management - 08.02.2017

Automating quality operations isn’t typically seen as being sexy, I know. But if automating your quality operations saves you time on essential tasks, thus saving you money, and saving money is sexy, then isn’t automating quality operations, in turn, also sexy? Like any entrepreneur, I enjoy making money, but as the head of a...

Out of the box Quality Management System (QMS) Save Money

Out of the Box: A Path to Success

Quality Management - 07.19.2017

This is the third blog in a series about the expression “Out of the Box” and how it relates to the Life Sciences industry. In the first blog, I discussed thinking out of the box. In the second blog, I discussed the benefits and shortcomings of buying out of the box software. In this third blog, I am going to discuss why companies...

Buying out of the box sofware: Biotech, pharma, medical devices

Buying Out of the Box Software

Quality Management - 07.12.2017

In this blog, I will discuss the benefits of buying out of the box software. In my previous blog in this series, I discussed thinking out of the box in the Life Sciences industry. In my next blog, I will discuss how you can do both and be successful. Purchasing out of the box software has definite benefits. It means that the...

Thinking Out of the Box in the Life Science

Thinking Out of the Box in the Life Sciences

Quality Management - 07.05.2017

Out of the box is a much-used expression but with a couple of completely different meanings! In this blog, I will discuss thinking out of the box. In the next blog, I will discuss the benefits and shortcomings of buying products out of the box. In the last blog, I will explain how you can do both and be successful. For some...

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

Top 10 Quality & Best Practices Blogs of the Last Year

Quality Management - 06.16.2017

At SOLABS, we're lucky enough to have Brian Graeff (former VP of Quality Operations at Sunovion Pharmaceuticals Inc.) and John Carkner (former President and CEO at Pillar5 Pharma Inc.) on our team. Every month Brian and John publish a Quality & Best Practices article to give you their insights into how best to manage common challenges...

Lean Manufacturing: Efficiency in Pharma, Biotech, Medical Devices

Lean Manufacturing and Quality

Lean Manufacturing - 05.31.2017

Lean manufacturing has been defined as the systematic elimination of waste in manufacturing systems. While I am certainly not an expert on lean implementation, I have seen firsthand the tangible benefits of the application of lean thinking to quality processes. Aspects of waste addressed by lean principles include:...

Communicating an Issue with Sr. Management at Life Sciences Companies

Issue Escalation: 5 Tips for Communicating with Senior Management

Quality Management - 04.26.2017

A trait that many leaders in the life sciences share is that they don’t like surprises. Perhaps they don’t mind pleasant surprises, but generally, they want to hear about issues promptly. While there are often formal notification requirements for quality issues, there are also sound business reasons for informing the leadership...

Quality Manufacturing Safety in Pharma & Biotech

Quality and Safety Have A Lot in Common

Quality Management - 03.22.2017

Aside from the obvious moral obligation, most organizations in the Life Sciences industry invest in safety programs for very sound business reasons: Employees are an organization’s most valuable resource, and ensuring their safety also safegaurds the organization’s value Similarly, while there is an ethical duty to produce...

Food & Drug Administration Contract Manufacturing Pharma Guidance

FDA Contract Manufacturing Guidance and EQMS

Quality Management - 02.01.2017

Recently published guidance from the FDA (Contract Manufacturing Arrangements for Drugs: Quality Agreements, November 2016) outlines their expectations and suggestions around contract manufacturing relationships and Quality Agreements. In the simplest summary of this guidance, it suggests that the product owner and the contractor are...

Production of pharmaceutical product documentation

Product Documentation: Essential to an Effective Quality Program

Quality Management - 01.04.2017

Provenance – Not Just for Fine Art! The term “provenance” is used in the art world in reference to the evidence that supports the authenticity of a work of art. It is what differentiates a valuable classic painting from a clever copy. In the production of pharmaceutical products, I like to think of the documentation that...

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...

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...