You know you need a computer systems audit, but that’s literally the extent of what you know.
Has this ever been you?
Yes, you use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply. Terms like “cloud computing” make you feel slightly queasy. You’d rather get a root canal than discuss “distributed processing.” Your expertise is in manufacturing. Or clinical research. Or non-clinical lab operations. And somehow it’s your job to make sure an effective and properly-sized system audit is conducted. Great.
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Showing posts with label QA. Show all posts
Showing posts with label QA. Show all posts
Tuesday, July 18, 2017
Coping with Scoping Your CSV/Part 11 Audit
Labels:
audit,
cloud,
COTS,
CSV,
Part 11,
QA,
system,
validation,
vendor qualification
Tuesday, April 26, 2016
Movie Quotes for QA Professionals
What if your favorite movie quotes were written for QA professionals? Would they be as memorable? We think so, but we’ll let you decide.
In the fall of 2015, the internet was rife with tweets sporting the hashtag #ScienceMovieQuotes. Creative scientists repurposed their favorite movie quotes, gleefully infusing them with nerdy humor for the entertainment of their colleagues. Such a great idea was just asking to be stolen. And who are we to resist the siren call of piracy? So here’s our best attempt at making #QAmovieQuotes go viral.*
…And because the rhymes were just too good, we couldn’t resist…
If you’re feeling creative, here are the American Film Institute’s 100 greatest movie quotes of all time. Please share your humor! (Fair warning – we took all the good ones.)
By Laurie Meehan
________________________________________________
* Thanks to Robyn Barnes of MasterControl for this fun idea.
Photo credits
Brando: User:Aggiorna / CC BY-SA-3.0, changes made
Badge: User:Dandvsp / Wikipedia Commons / CC BY-SA-3.0
Nicholson: User:Nikita~commonswiki / CC BY-SA-2.5, changes made
Shawn: Sam Felder / CC BY-SA-2.5, changes made
Leigh: Trailer Screenshot, A Streetcar Names Desire,1951, Public domain
Freeman: User:FRZ / CC BY-SA-2.5, changes made
Aladdin Chocolates: Hans Lindqvist, 2009, Public domain
Flower: Walt Disney, Bambi, 1942, Public Domain
Doune Castle: Keith Salveson / CC BY-SA-2.0
Bogart: Trailer Screenshot, Casablanca,1942, Public domain
Newman: Warner Bros. Entertainment, Cool Hand Luke, 1967, Public Domain
In the fall of 2015, the internet was rife with tweets sporting the hashtag #ScienceMovieQuotes. Creative scientists repurposed their favorite movie quotes, gleefully infusing them with nerdy humor for the entertainment of their colleagues. Such a great idea was just asking to be stolen. And who are we to resist the siren call of piracy? So here’s our best attempt at making #QAmovieQuotes go viral.*
“I’m gonna schedule an audit… he can’t refuse.”
- Vendor Oversight Manager at Corleone Clinical
“Batches? We don’t need to see no stinking batches!”
- Said no GMP auditor ever.
Auditee: “You want candor?”
Auditor:” I want the proof.”
Auditee: “You can’t access the proof!”
(Not even A Few Good Men can view electronic source documents at some sites.)
Auditor:” I want the proof.”
Auditee: “You can’t access the proof!”
(Not even A Few Good Men can view electronic source documents at some sites.)
"Contemporaneous. You keep using that word.
I do not think it means what you think it means."
- Inigo Montoya, CCRP
“I’ve always depended on the kindness of trainers.”
Oh no. Who let Blanche talk to the Inspectors?
“I love the smell of Wite-Out in the morning.”
- Compliance Auditor, Fraud Division
“Get busy complyin’ or get busy tryin’.”
(Motivational poster at Shawshank Consulting)
“Fecal transplants happen.”
“Audits are like a box of chocolates…”
[Sorry.]
“That’s all right. He can call me ‘Sour’ if he wants to. I don’t mind.”
Not every audit is like a trip to Magic Kingdom.
Jr. Auditor: “How do you know it’s a glitch?”
Sr. Auditor: “It looks like one.”
It’s not witchcraft; it’s experience – the holy grail of the QA industry.
“Of all the org charts in all the sites in all the world, you had to look into mine.”
Qualification records are amiss at Casablanca Research Institute.
And amiss is still amiss.
[Again, sorry.]
“What we’ve got here is a failure to refrigerate”
Dr. Luke’s Hand might be Cool, but his Investigational Product isn’t.
(Is the study drug supposed to be the Color of Money?)
…And because the rhymes were just too good, we couldn’t resist…
“What we’ve got here is a failure to investigate.”
“What we’ve got here is a failure to remediate.”
CAPA fail, Newman Style
If you’re feeling creative, here are the American Film Institute’s 100 greatest movie quotes of all time. Please share your humor! (Fair warning – we took all the good ones.)
By Laurie Meehan
________________________________________________
* Thanks to Robyn Barnes of MasterControl for this fun idea.
Photo credits
Brando: User:Aggiorna / CC BY-SA-3.0, changes made
Badge: User:Dandvsp / Wikipedia Commons / CC BY-SA-3.0
Nicholson: User:Nikita~commonswiki / CC BY-SA-2.5, changes made
Shawn: Sam Felder / CC BY-SA-2.5, changes made
Leigh: Trailer Screenshot, A Streetcar Names Desire,1951, Public domain
Freeman: User:FRZ / CC BY-SA-2.5, changes made
Aladdin Chocolates: Hans Lindqvist, 2009, Public domain
Flower: Walt Disney, Bambi, 1942, Public Domain
Doune Castle: Keith Salveson / CC BY-SA-2.0
Bogart: Trailer Screenshot, Casablanca,1942, Public domain
Newman: Warner Bros. Entertainment, Cool Hand Luke, 1967, Public Domain
Tuesday, December 9, 2014
What Does Risk-based Monitoring Mean for QA Auditing?
By now, we all know that risk-based monitoring isn’t just about changing the role of the CRA; it’s transforming the way clinical studies are managed. So what does that mean for QA teams who audit these new processes? Polaris president Celine Clive led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting.
It’s a slippery subject. Traditional monitoring relied on the gold standard of on-site visits every 4-8 weeks and 100% SDV. RBM is not replacing this standard with another. RBM is a framework for customizing a monitoring approach for each study, and guess what -- “custom” is a lot trickier to audit than “standard.”
Labels:
audit,
auditing,
auditor,
CSV,
NCRAF,
QA,
Quality Assurance,
Risk-based Monitoring,
SDV,
validation
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