WHO: GOOD DATA AND RECORD MANAGEMENT PRACTICES

Some good stuff in this guidance….particularly the bit on True copies…..

GUIDANCE ON GOOD DATA AND RECORD MANAGEMENT PRACTICES (SEPTEMBER 2015) DRAFT FOR COMMENT

True copy: A true copy is a copy of an original recording of data that has been certified to confirm it is an exact and complete copy that preserves the entire content and meaning of the original record, including in the case of electronic data, all metadata and the original record format as appropriate.

Full Guidance:  http://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidance-on-good-data-management-practices_QAS15-624_16092015.pdf

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FCC votes to “unlock the cable box”

I like seeing disruption in the technology sphere from the technology side rather than the regulatory side. It happened to be the Republicans on the regulatory side, but the Dems have their days too.

~TJK

http://arstechnica.com/business/2016/02/fcc-votes-to-unlock-the-cable-box-over-republican-opposition/

 

FCC votes to “unlock the cable box” over Republican opposition

Customers should be able to watch TV on any device without CableCard, FCC said.

Mr.TinDC

The Federal Communications Commission today approved a Notice of Proposed Rulemaking (NPRM) that seeks to give consumers more choices in the set-top boxes they use to watch cable TV.

The vote was 3-2, with Chairman Tom Wheeler and fellow Democrats Mignon Clyburn and Jessica Rosenworcel voting in favor of the proposal, while Republicans Ajit Pai and Michael O’Rielly voted against. An NPRM is not a final vote. Instead, this will kick off a months-long public comment period leading up to a final vote that is likely to happen before the end of this year…..

Vaccines, Real Medicine

I’m so tired of #Homeopathabullshit….

~TJK

Sharepoint White paper on Part 11

As published by Microsoft

SharePoint 2013 Configuration Guidance for 21 CFR Part 11 Compliance

Thoughts?

~TJK

 

Part 11 Cloud Compliance Course

 

Timothy J. Kuhn: I’m not affiliated with the provider of the course as you may have surmised. I’ve been looking for a course for some of my team members and this came up in my feed so I thought I’d share. It looks useful; has anyone else taken it?

Best,

TJK

“21 CFR Part 11 Compliance for SaaS/Cloud Applications” has been pre-approved by RAPS as eligible for up to 12 credits

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Key Focus:

• Understand what is expected in Part 11 and Annex 11 inspections
• Avoid 483s and Warning Letters
• Learn how to buy COTS software and qualify vendors
• Implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds
• Requirements for local, SaaS, and cloud hosting
• How to select resources and manage validation projects
• “Right size” change control methods that allows quick and safe system evolution
• Minimize the validation documentation to reduce costs without increasing regulatory or business risk
• Write test cases that trace to elements of risk management
• Protect intellectual property and keep electronic records safe

Agenda: http://www.complianceonline.com/21-cfr-part-11-compliance-for-saas-cloud-applications-seminar-training-80202SEM-prdsm?channel=Nisha_OB

LA Hospital Pays Hackers Nearly $17,000 To Restore Computer Network : The Two-Way : NPR

On security…

LA Hospital Pays Hackers Nearly $17,000 To Restore Computer Network

Updated February 18, 201610:36 AM ET
Published February 17, 20169:08 PM ET
LAURA WAGNER

The Hollywood Presbyterian Medical Center was hacked for ransom earlier this month.

A Los Angeles hospital paid a nearly $17,000 ransom to hackers who breached and disabled its computer network, the hospital said in a statement LA Hospital Pays Hackers Nearly $17,000 To Restore Computer Network

The Hollywood Presbyterian Medical Center was hacked for ransom earlier this month.
Junkyardsparkle via Wikimedia Commons
A Los Angeles hospital paid a nearly $17,000 ransom to hackers who breached and disabled its computer network, the hospital said in a statement Wednesday…

Hear Hear, Apple! Hear Hear, Google!

In a move of solidarity, Google supports Apple in its fight against the US government to provide a “back door” into the popular iPhone…a move that would allow the government to hack  all of Apple’s customers.

#privacy #nobackdoor

~TJK

http://finance.yahoo.com/news/heres-googles-ceo-just-said-000854021.html

Here’s what Google’s CEO just said about Apple’s battle with the FBI

By Jillian D’Onfro 5 hours ago

 

View photo

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(Justin Sullivan/Getty Images)
Google CEO Sundar Pichai.

Google CEO Sundar Pichai just weighed in on Apple’s battle with the FBI, which has ordered Apple to help it unlock the phone of one of the shooters who killed 14 people in San Bernardino, California, last year in an apparent terrorist act.In a series of tweets, Pichai wrote that although Google gives “law enforcement access to data based on valid legal orders,” that is “wholly different than requiring companies to enable hacking of customer devices and data,” which could set a “troubling precedent.”

British Intelligence is Legally Allowed to Hack Anyone, Court Says

Wow….privacy is dead.

Hacking of computers, smartphones and networks in the United Kingdom or abroad by the Government Communications Headquarters (GCHQ) is LEGAL, the UK’s Investigatory Powers Tribunal (IPT) ruled….

http://thehackernews.com/2016/02/gchq-hacking-news.html?m=1

The radical plan to destroy time zones – The Washington Post

I would love this. “What time is it on Earth?” #UTC https://www.washingtonpost.com/news/worldviews/wp/2016/02/12/the-radical-plan-to-destroy-time-zones-2/?tid=sm_fb
~TJK

All opinions are not equal