October 4, 2022
By Kevin Ballard, Senior Project Manager, Validation on Demand, MasterControl
The FDA requires companies to validate software used in regulatory environments. But the processes involved in validation are usually a drain on your time and resources. By following six fundamental steps, you can adopt and validate software systems with greater ease.
November 17, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Validation has historically been a time-consuming, painful undertaking for medtech companies that depend on commercial off-the-shelf software solutions. As that the bulk of that burden shifts away from users and onto software providers, it’s getting easier to take a risk-based approach to validation.
August 17, 2021
By David Jensen, Staff Writer, MasterControl
The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 guidance made electronic records and signatures as valid as paper records and handwritten signatures. The guidance changed the dynamic of data and records management by advocating modernized technology in the life sciences industry.
July 30, 2021
By Gina Guido-Redden, Co-Founder and COO, Coda Corp USA
To compensate for the lack of agency guidance and still meet regulatory requirements, the medical device industry turned to Gauge Repeatability & Reproducibility (Gauge R&R) studies, but the FDA is making it clear these studies are not a suitable tool for validation.
June 18, 2021
By James Jardine, GxP Lifeline Editor, MasterControl
Natural and man-made disasters aren’t just terrifying – they can signal the death of your business if they lead to data loss, prolonged system outages, or downtime. Learn why cloud technologies take the panic out of disaster recovery and validation.
July 27, 2020
By Sarah Beale, Staff Writer, MasterControl
How many times have you done something and immediately wished you could undo it? Or how many times have you wished you knew the outcome of something beforehand? Since time travel still eludes us, the best we can hope for is to try to fix our mistakes and anticipate future ones. In the regulated industry this is called corrective and preventive action (CAPA).
March 31, 2020
By Mike Rigert, Staff Writer, MasterControl
In a life sciences industry that highly values risk reduction, Good Automated Manufacturing Practices (GAMP) principles offer key insights on computer validation. GAMP 5 offers companies guidelines that can help ensure greater computer system compliance that reduces risk.
November 7, 2019
By Sarah Beale, Staff Writer, MasterControl
Technology’s getting more advanced and our validation practices are finally starting to catch up. During the 2019 Masters Summit, Validation Product Manager Erin Wright gave us a glimpse at what’s in the future. Read about the next big trends in validation, including the U.S. Food and Drug Administration’s (FDA) stance.
July 9, 2019
By Ian Lucas, Partner and Director, SeerPharma
It’s essential for life sciences and other regulated companies to certify that their IT infrastructure is up to specifications through system validations and qualifications, not only for better compliance, but also to ensure the quality and integrity of their data and production documentation.
June 27, 2019
By Dan O'Leary, President, Ombu Enterprises
Medical device makers could save themselves time and heartache in reducing the number of regulatory findings when it comes to the FDA’s CFR Part 820 quality system regulations and ISO 13485. How? By understanding the benefits you get by fully implementing process validation to achieve higher levels of compliance.
Unsure about cloud validation? You’re not alone. Many life sciences and other regulated companies are unfamiliar with cloud-based quality management system (QMS) and wary about its validation. After all, their regulatory compliance is at stake.
April 3, 2019
By Sandra Fadel, Product Management eCTD Templates and EURS Validator, EXTEDO
In order to maintain the highest standards, regulatory bodies are continually tweaking their drug registration requirements for highly controlled products. To keep up with these changes and avoid costly technical errors during the submissions process, pharma organizations are making sure they’re up to speed with regulators’ most up-to-date validation criteria.
August 9, 2018
By David Jensen, Staff Writer, MasterControl
The inclusion of software in medical devices is opening up new avenues for health care treatments. However, it also means medical devices are becoming more complex. New innovations in medical device development should compel device manufacturers to revamp their design and development strategies. More time and effort needs to be spent on design control, risk management and cybersecurity. The increase of software in medical devices will a noticeable impact on the approaches to medical device design and manufacturing.
August 2, 2018
By Sarah Beale, Staff Writer, MasterControl
Adulterated supplements and adverse events have long been the bane of the nutraceutical industry. However, this shouldn’t and doesn’t have to be the norm. By qualifying suppliers or ingredients, nutraceutical companies not only comply with CGMPs, they also protect their customers.
July 5, 2018
By James Jardine, GxP Lifeline Editor, MasterControl
Radical, whirlwind change is a core feature of the medical device industry. A clinical/regulatory expert provides insight into the clinical developments currently shaking up the device world and explains how device companies can adapt and thrive in a burgeoning industry that seems to reinvent itself daily.
