Pharmaceuticals Archives - SOLABS

All posts tagged “Pharmaceuticals”

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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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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...

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Pharma, Medical Device, Biotech Quality Manangement System Selection Guide

EQMS Software Evaluation & Selection Guide for the Life Sciences

EQMS - 02.03.2016

The EQMS Software Evaluation and Selection Guide has been designed by the SOLABS Quality & Best Practices Unit expressly to provide...

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GxP Environments: Document Control in the Context of Change Control

Document Control in the Context of Change Control Within GxP Environments

Document Control - 11.17.2015

It is well-known that in GxP regulated industries, document control is a linchpin of quality and compliance. For several years now,...

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EQMS Implementation & Use in the Clinical Trials Industry: Part 1- EQMS and e-Learning Tools

Clinical Trials - 09.09.2015

We recently had the opportunity to interview Nathalie Bourgouin, PMP, and Senior Consultant and Project Manager at Skillpad, to gather her...

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What Is My License to Operate (LTO) Worth?

Quality Management - 08.26.2015

The Life Sciences industry has a history of heavy regulation. Whether your company markets pharmaceutical, biotechnology or medical device...

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Corrective Action Preventive Action

Corrective Action & Preventive Action (CAPA) Effectiveness Checks

Corrective & Preventive Action - 08.12.2015

The need for periodic performance and effectiveness checks should be agreed upon and documented as part of a compliant Corrective Action &...

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EQMS Implementation: Pick the Right Person and System for the Job

Implementation - 07.15.2015

We have all heard the analogy of building a house, and the inherent importance of a good foundation—and how this might apply to the...

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Challenges in Change Control and Automation

Automation - 06.17.2015

I enjoy exchanging ideas with Mr. Graeff and Mr. Prince on quality operations, best practices, and quality management in general. First...

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Good Practices for Document Control: Categorizing, Classifying & Tagging

Document Control - 02.10.2014

Continuing our blog series on Good Practices for Document Control in the Life Sciences, this post will focus on stage 1 “Categorizing,...

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Does Enterprise Software Integration Really Matter in the Life Sciences Industry?

Implementation - 09.14.2012

At the moment, I would say “No, it does not”. Recently, we have seen a tremendous focus on the introduction of enterprise software...