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The Importance of the FDA's Upcoming Guidance on Computer Software Assurance (CSA)

June 2nd, 2020 by Julian Oberle

The Importance of the FDA's Upcoming Guidance on Computer Software Assurance (CSA) Companies that are regulated by the U.S. Food and Drug Administration (FDA) are. [...] Read More

Posted in Computer Software Assurance (CSA)

This is How Digital Transformation Can Transform Your Business

May 4th, 2020 by Álvaro Spindola

This is How Digital Transformation Can Transform Your Business Currently, digital transformation is a hot buzzword, and it’s something that. [...] Read More

Posted in Digital Transformation

This is How ISO 9001 Improves Your Company's Quality Management

April 3rd, 2020 by Julian Oberle

This is How ISO 9001 Improves Your Company's Quality Management To stay competitive, every organization should consider what they can do to. [...] Read More

Posted in Quality Management System

How Do Medical Device Manufacturers Maintain Data Integrity?

April 2nd, 2015 by Henry Macartney

How Do Medical Device Manufacturers Maintain Data Integrity? Is cybersecurity something you consider when designing a new product? As. [...] Read More

Posted in FDA & European Regulations

Harmonization Processes Through ICH  

September 3rd, 2014 by James Francum

Harmonization Processes Through ICH   The methodologies your firm employs in the creation of pharmaceuticals,. [...] Read More

Posted in Quality Risk Management System

What Color Pen Can I Use to Sign Documents?

August 14th, 2014 by James Francum

What Color Pen Can I Use to Sign Documents? Not sure which pen to use? Although it seems like an amusing topic, your choice. [...] Read More

Posted in Pen Colors for Signing Documents

Defining Critical Quality Attributes in the Pharmaceutical Manufacturing Process

July 15th, 2014 by Zuhdi Hussein

Defining Critical Quality Attributes in the Pharmaceutical Manufacturing Process Pharmaceutical firms that wish to create product lines and cater to consumers. [...] Read More

Posted in Risk Management

Clarifying the Difference in Equipment Qualification and Process Validation

June 10th, 2014 by James Francum

Clarifying the Difference in Equipment Qualification and Process Validation How do you know your life sciences firm is maintaining compliance? While FDA. [...] Read More

Posted in Quality Management System

Meeting Compliance Goals With Deviation Management And CAPA Systems

June 2nd, 2014 by Henry Macartney

Meeting Compliance Goals With Deviation Management And CAPA Systems Your firm will experience compliance failures from time to time. In the realm. [...] Read More

Posted in Quality Management Systems

Instituting Effective FDA Gap Analysis Policies

April 25th, 2014 by Zuhdi Hussein

Instituting Effective FDA Gap Analysis Policies When GxP firms take actions to maintain compliance with recommendations from. [...] Read More

Posted in Quality Systems Regulation