Compliance Archives - SOLABS

All posts tagged “Compliance”

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...

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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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The Right EQMS: The Best Investment You’ll Make This Year

Quality Management - 02.10.2016

By John Carkner, Senior Consultant, SOLABS Quality Assurance & Best Practices Unit Why The Right Enterprise Quality Management System...

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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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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...

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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 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...

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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...

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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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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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Audit Trails: Patterns and Part 11 Compliance

Audits - 04.22.2014

The requirement for audit trails has not come about with the evolution of electronic systems. The ability to audit multiple sorts of...

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