Companies that are regulated by the U.S. Food and Drug Administration (FDA) are.
[...] Read More
The Importance of the FDA's Upcoming Guidance on Computer Software Assurance (CSA)
June 2nd, 2020 by Julian OberlePosted in Computer Software Assurance (CSA)
This is How Digital Transformation Can Transform Your Business
May 4th, 2020 by Álvaro Spindola
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
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
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
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
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
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
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
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
When GxP firms take actions to maintain compliance with recommendations from.
[...] Read More
Posted in Quality Systems Regulation
