Thursday, 27 April 2017Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions
As product recalls, product bans, drug shortages, plant shutdowns, and enforcement actions continue to rise, industry and regulators alike are looking for answers on how to change the perspective of the Life Sciences industry from one of Compliance
to one of Quality
Is the solution to increase the amount of data we capture and report within our documents? After all, we so carefully record a great deal of data in a Quality Management System
(QMS). No, data in and of itself, is not the answer. While data/metrics go a long way toward accomplishing the shift from compliance to quality, that data needs to be transformed into intelligence that is informed, actionable, proactive, and predictive.
Friday, 21 April 2017Justin L. Smith, Manager of Product Management, Pilgrim Quality Solutions
Last week we hosted a webinar titled “Regulations, Risk, and Responsibilities: Closing the Gap on ISO 13485:2016 Compliance.” The webinar was presented by Dan O’Leary, President of OMBU Enterprises
, and Kari Miller, Pilgrim’s Vice President of Regulatory and Product Management. If you were unable to attend the webinar, you can watch the Closing the Gaps in ISO 13485:2016 Compliance On-demand Webinar
During the webinar, Dan presented several areas where the latest version of ISO 13485 will present significant challenges to medical device manufacturers. These areas include supplier management, complaint handling, integrating regulatory requirements into the quality system, and the way your company approaches risk.
Thursday, 13 April 2017Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions
Transitioning to ISO 13485:2016 compliance is the top priority throughout the medical device industry right now. The industry is racing to absorb information on the latest version of the standard. Do you have a plan in place for getting your organization up-and-running with ISO 13485:2016? These resources will help you develop, fine tune, and implement your transition plan.
Thursday, 06 April 2017Tom Colgan, Director of Cyber Security, Pilgrim Quality Solutions
As agents of quality and compliance within the Life Sciences industry, we are all well aware of the importance of security awareness training in order to be compliant with various frameworks, laws, and regulations, including HIPAA
. But in practice, does your organization’s awareness program simply “check the box,” or do you believe your efforts are having an impact?
Thursday, 30 March 2017Kumud Bhattarai, Director of Software Development & Enterprise Architect, Pilgrim Quality Solutions
In the era of applications that are either web-based or have some connection to web-based content, making applications secure is one of the most important factors that should be in the back of any system architect’s mind.
Every so often we hear big news about large companies getting breached and private information being stolen from the system. Most of these activities can be attributed to either human weaknesses (such as phishing attacks) or system weaknesses (such as zero-day exploits).