Compliance with 21 CFR Part 11 is a big deal for life sciences companies. Failure to meet Part 11 requirements can result in serious consequences like product recalls and legal actions. Make sure all your regulatory bases are covered with this 21 CFR Part 11 compliance checklist.
November 1, 2022
By David Jensen, Staff Writer, MasterControl
According to the U.S. Food and Drug Administration’s (FDA) guidance on data integrity, all data for regulated products must be complete, reliable, accurate, and consistent. Learn data management best practices to help ensure compliance with the stringent data integrity regulations.
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.
May 13, 2021
By David Jensen, Staff Writer, MasterControl
More regulated companies have transitioned to maintaining records and submitting information electronically. This involves tight data and records management and audit trails. In this article, Seyed Khorashahi, executive vice president of medical devices and CTO at Regulatory Compliance Associates (RCA) Inc., shares valuable insight on the anatomy of an audit trail and advises companies on how to comply with this critical component of 21 CFR Part 11.
September 10, 2020
By James Jardine, GxP Lifeline Editor, MasterControl
FDA 21 CFR Part 11 does not invalidate the predicate rules that were established for paper-based document management systems, it simply builds upon and reinforces those existing rules in digital platforms. Learn about the symbiotic nature of Part 11 and FDA predicate rules and discover how an awareness of their relationship is fundamental to easing compliance burdens.
September 2, 2020
By Kevin Grimes, Vice President, Arbour Group LLC
Life sciences companies are migrating the cloud. To be successful with cloud compliance in a regulated environment, it’s important to understand the key challenges and know how to address them. While cloud host providers offer security features, it is your organization’s responsibility to confirm the provider is compliant.
May 14, 2020
By Matt Brawner, Director of Sales Execution, Sequence, and David Jensen, Staff Writer, MasterControl
Complying with the many record and data management requirements for 21 CFR Part 11 and data integrity can be daunting. In this article, Matt Brawner, data integrity subject matter expert (SME) at Sequence Inc., explains how companies can integrate Part 11 and data integrity processes to accelerate pathways to approval and deliver higher quality products to market.
July 31, 2018
By Tifany Desprez, Apsalys, a MasterControl Partner
France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.
April 3, 2018
By David Jensen, Staff Writer, MasterControl
First the bad news. As long as health care-related data remains a valuable commodity, security breaches and data theft will persist. The good news is global regulatory agencies are ramping up their cybersecurity measures in an effort to restore relevance to the “protection” component of protected health information (PHI).
