Several months ago we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Regarding “the organization” that needs to inform the FDA of the intended use of electronic signatures, in a CRO/Sponsor relationship, who is responsible: the […]
Sally Miranker
As the Head of Validation in Perficient’s life sciences practice, Sally Miranker is responsible for overseeing the Computer System Validation (CSV) methodology, System Development Life Cycle (SDLC), and all project-related validation activities. She has over 20 years of experience in the industry with almost a decade focused on implementing computer systems within regulated environments. Her knowledge and experience contribute to her ability to ensure that Perficient’s internal and client systems are implemented effectively, in compliance with internal procedures and external regulations, and following best industry practices. Prior to joining the company in 2009 via the acquisition of BioPharm Systems, Sally held a Siebel Systems Analyst position at Amylin Pharmaceuticals.
Blogs from this Author
Are Email Attachments Subject To 21 CFR Part 11?
On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: In one of the initial slides, you mentioned that documents attached to emails do not fall under 21 CFR Part 11. Could […]
Does 21 CFR Part 11 Apply To CTMS, CDMS, Or EMR/EHR Systems?
On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Does 21 CFR 11 apply to a CTMS (clinical trial management system), CDMS (clinical data management system), EMR (electronic medical record), or […]
Are Test User Accounts Subject To 21 CFR Part 11?
On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Regarding user accounts: During the User Acceptance Testing (UAT) of a system, are these accounts regulated the same way or can ‘generic’ […]
How Much System Access Should We Give An FDA Inspector?
On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: The Scope section requires access to electronic records and signatures (ER/ES) at all times. What if the electronic system used by a […]
Can Clinical Trial Software Be Validated In The Cloud?
We recently discussed customizing and configuring clinical trial software that is hosted in the cloud. For the final post in our “cloud fact or fiction” blog series, we’ll discuss the hot topic of validation.
How Are GAMP 5 And 21 CFR Part 11 Related, If At All?
On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: What about GAMP 5? How does it fit into 21 CFR? How to combine both?
Is A Training System Required To Comply With 21 CFR Part 11?
On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Is a web-based training system required to be Part 11 compliant?
Is A Web-Based QMS Required To Comply With 21 CFR Part 11?
On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: Is a web-based quality management system that includes document control and CAPA modules required to be 21 CFR Part 11 compliant?
Are Hosted Systems Open Or Closed Under 21 CFR Part 11?
On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question: When Argus is hosted by Perficient, is it considered an open or closed system for the company that contracted Perficient to host?
Is Your Clinical Trial Software Secure In The Cloud?
In our last “cloud fact or fiction” post, we pointed out that hosting your clinical trial software in the cloud gives companies unparalleled access to their data due to high system uptime and ease of access to systems. This time around, we’ll discuss cloud security. Claim #5: Clinical and safety data in cloud systems is not […]