21 CFR Part 11 Posts

Get a Grip on your Data Integrity

Get a Grip on your Data Integrity

Christoph Knez, Sr. Account Executive, Pilgrim EMEA

Data Integrity is one of today’s hot topics in the Life Sciences industry. Look at the agenda of just about any industry conference, summit, or workshop event over the last two years, and you’ll notice Data Integrity has found its way into nearly every one.

If you listen carefully to attendees and others in the industry who are responsible every day for ensuring data integrity, you’ll hear how this very complex requirement creates a lot of anxiety among many companies when they examine their particular quality management processes. Their main objective is to avoid any observations by regulatory bodies resulting from data integrity issues. But why is it so complex?

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Eliminate the Validation Bottleneck

Eliminate the Validation Bottleneck

LNS Research recently published a great blog post on the State of the Market for Software Validation in Life Sciences. Click here to read the full post from Dan Jacob, Research Analyst at LNS Research.

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Lessons Learned Integrating SAML SSO and WS-Federation for Federated Authentication

Lessons Learned Integrating SAML SSO and WS-Federation for Federated Authentication

Leo Barcenas, Sr. Software Engineer, Pilgrim Quality Solutions

Last month we published the Basics of Federated Single Sign-On (FedSSO). This article will discuss Single Sign-On for federated authentication a bit deeper and explore what we learned by implementing and integrating SmartSolve to Identity Providers (IdP).

FedSSO (Federated Single Sign-On) Background

Federated Single Sign-On is a combination of two concepts: Federated Identity and web-based Single Sign-On. Federated Identity is the ability to link different applications or services with their mutual users. It provides a way for partner services to agree on a common and shared definition about the identity of a user authorized to use a service. There is only a single credential for each user. Federated Identity provides a simpler and easier way for administrators to manage and secure users. It also makes it easier for users to manage their credentials. (more…)

Five Years, Twenty-Six Days

Five Years, Twenty-Six Days

Mark Crawford

On October 15, the FDA published guidance regarding new efforts to reduce the average total wait time for 510(k) decisions from an average of 150 days in FY 2012 to 124 days in FY 2017. They will seek to do this by hiring more reviewers and investing more resources, both made possible by the Congressional approval of the Medical Device User Fee Amendments of 2012 (MDUFA III) earlier this year. (more…)

FDA Seeks to Standardize Electronic Data Submittals

Mark Crawford

In February the FDA released a guidance document proposing a standardized format for submitting clinical and nonclinical data to the agency. The FDA maintains that by following this protocol early in the product development cycle medical device and pharmaceutical companies can reduce bottlenecks and speed up the approval process. (more…)

Moving Into the New Generation of 21 CFR Part II

In 1997, it wasn’t uncommon to hear “You’ve got mail!” when you used your telephone to log onto the Internet. This is the same year that the Food and Drug Administration (FDA) issued 21 CFR Part 11, electronic records. Six years later, in 2003, you were probably using broadband and going directly to the Internet. In this year, the FDA issued a Guidance for Industry of Part 11, Electronic Records; Electronic Signatures. It shouldn’t be any surprise that seven years later, the FDA is piping up about Part 11 again. This time, it is in the form of revised enforcement discretion of Part 11.  (more…)