Clinical Trials Archives - SOLABS

All posts tagged “Clinical Trials”

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...

Read more → Comments Off on How Optimizing Access to Reports & Detailed Metrics Maximizes ROI
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...

Read more → Comments Off on Does Your CAPA Process Need a CAPA?
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...

Read more → Comments Off on Document Control & Change Control: Periodic Reviews & Retraining
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...

Read more → Comments Off on EQMS Software Evaluation & Selection Guide for the Life Sciences

EQMS Implementation & Use in the Clinical Trials Industry: Part 6 – Wrap-up

Clinical Trials - 12.16.2015

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

Read more → Comments Off on EQMS Implementation & Use in the Clinical Trials Industry: Part 6 – Wrap-up

EQMS Implementation & Use in the Clinical Trials Industry: Part 5 – Implementation

Clinical Trials - 12.02.2015

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

Read more → Comments Off on EQMS Implementation & Use in the Clinical Trials Industry: Part 5 – Implementation
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,...

Read more → Comments Off on Document Control in the Context of Change Control Within GxP Environments

EQMS Implementation & Use in the Clinical Trials Industry: Part 4- Small vs. Large Companies

Clinical Trials - 10.05.2015

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

Read more → Comments Off on EQMS Implementation & Use in the Clinical Trials Industry: Part 4- Small vs. Large Companies

EQMS Implementation & Use in the Clinical Trials Industry: Part 3- Why SOLABS QM is Well-Suited for Clinical Trial Companies

Clinical Trials - 09.30.2015

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

Read more → Comments Off on EQMS Implementation & Use in the Clinical Trials Industry: Part 3- Why SOLABS QM is Well-Suited for Clinical Trial Companies
Paper to software clinical trials

EQMS Implementation & Use in the Clinical Trials Industry: Part 2- Moving from Paper to Software

Clinical Trials - 09.23.2015

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

Read more → Comments Off on EQMS Implementation & Use in the Clinical Trials Industry: Part 2- Moving from Paper to Software

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...

Read more → Comments Off on EQMS Implementation & Use in the Clinical Trials Industry: Part 1- EQMS and e-Learning Tools

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...

Read more → Comments Off on What Is My License to Operate (LTO) Worth?
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 &...

Read more → Comments Off on Corrective Action & Preventive Action (CAPA) Effectiveness Checks

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...

Read more → Comments Off on EQMS Implementation: Pick the Right Person and System for the Job

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...

Read more → Comments Off on Challenges in Change Control and Automation

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,...

Read more → Comments Off on Good Practices for Document Control: Categorizing, Classifying & Tagging

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...