Diversified Plastics (DPI), a custom plastic injection moulder and additive manufacturer of high-precision components, has increased the capacity of its Acceleration Station to meet the rise in demand associated with the Covid-19 pandemic.

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.



Yet your Quality Assurance colleagues -- whether they’re from your internal QA department or an external compliance company -- need your input. They need to understand what software is being purchased, what services are being contracted, how and where components of the system are being implemented, and how the system will be used.

The good news is that the QA auditors can help you. They know that FDA favors a risk-based approach to validation and Part 11 implementation, and they even know what that means. They love to talk about configuration management and change procedures. They love gathering evidence that demonstrates your system works correctly and is in a state of control, and they know what rocks they should look under to find and fix vulnerabilities.

What follows are examples of the types of information you need to convey to QA – and that they should be asking you about – to properly size and scope an audit.

How do You Plan to Use the System?

Suppose you need to audit the supplier of a new Document Management System. The first thing an auditor would need to understand is how you plan to use the system. How mission critical are the documents you’re looking to store?  Are they covered under regulatory scope?  Maybe you plan to use the system as a collaboration environment for developing new SOPs. That would require a relatively low level of scrutiny, especially if you only plan to print out the finalized documents for wet ink signature. (As a point of comparison, if you plan to use the system to finalize SOP approval, the auditor would need to check that Part 11 requirements for electronic signatures are properly implemented.) What if the Document Management System will be housing critical GxP documents, such as Trial Master Files, Master Schedule Sheets, or Master Batch Records? In these cases, the validation would have to be far more thorough, and Part 11 electronic record features, such as audit trails and archiving functionality, would have to be implemented and verified.

Here’s another “use” example. Similar to the term “Document Management System,” the term “Analytics System” does not tell the whole story. From a business perspective, study start up (SSU) metrics may be vital for sponsors and CROs to collect and analyze. But since they have no regulatory impact, the FDA would not require an SSU analytics system to be validated. (That doesn’t necessarily mean you might not want to, though.) On the other hand, a system that performs statistical analysis on study data for regulatory submission is about as critical as it gets, and would require thorough validation and Part 11 implementation. Other analytics systems, such as dashboards that pull data from critical systems, might fall somewhere between these two extremes.

What is the Vendor Providing? And How? And Where?

If you need to audit a complex system, the questions QA will ask you will go beyond system use. The auditors will need to understand the combination of software and services the vendor is providing, and where the software and data reside.

• Does the software and data reside internally at your company or does the vendor provide a hosting service?
  If the vendor is hosting, the auditor needs to tour the facilities and review SOPs and records to evaluate physical security, staff training, environmental controls, backup procedures, disaster recovery plans, data retention, computer infrastructure, and change control.
  
  
• Does the hosting vendor own its own servers or does it, in turn, outsource that function to a 3rd party hosting company, (possibly even in the cloud)?
  If the hosting is outsourced, ideally an auditor would be able to visit the hosting site. Failing that, the auditor would ask questions about the vendor’s qualification processes and review SOPs that govern vendor selection/management procedures. If the vendor outsources other services beyond hosting, those services might need to be considered, as well.
  
  
• Is the vendor providing any other services?
  Many EDC vendors will provide study-specific services such as screen development and data entry validation edits. Auditors would need to review SOPs for providing these services and understand how the vendor tests and manages modifications to these components as the study proceeds.
  Sometimes computer systems vendors provide ancillary services, such as help desk functions and user account management. That would mean additional SOPs and training records for the auditor to look through.

Other Considerations

There are many. For example, where are you in the product life cycle? You ask different questions about a new system than you would about one that has been operating for a few years. Is the product Commercial off-the-shelf (COTS) or highly customized? COTS systems vendors often have their own validation package which auditors would review, and then ensure proper operation in the sponsor/CRO’s specific environment. A highly customized or custom-built system would require a more extensive validation process.


The Take Away

CSV/Part 11 audits will never be standardized, cookie cutter type activities; there are simply too many factors -- in too many combinations -- to consider. You want your QA efforts to be worth the money you spend and be able to answer the questions FDA says you need to be asking. If you’re unsure how to do that, that’s ok. Other people know, as long as you can help them understand how you plan to use the system, what software and services are being supplied, and how components of the system are being implemented.

In case you missed it, our previous post was Notes 2 Fix Your Notes 2 File.
_______________________________________________
Many thinks to Lisa Olson for sharing her insights with me.

All work and no play? Here's a work space with some playful humor built in.

Here's advice from people who know a lot about living in solitary, confined spaces.

Her new book Before the Lights Go Out investigates strategies for conquering the energy crisis before it conquers us.

Seen on my walk yesterday.

Hi again, everyone. This is really hard, isn't it?

First, I want to plug two services that are working harder than ever right now to save independent bookstores felled by the pandemic. As an alternative to Audible (which is owned by Amazon), please, please consider buying audiobooks from Libro.fm. And as an alternative to Amazon for hard copies of books, please, please check out Bookshop.

So, on the topic of coping. I thought I might describe what my days are like right now, the challenges that arise for me, and how I've been trying to meet them. As it happens, I have some special qualifications for meeting some of our current emotional challenges... because I've spent the last 25+ years living with and recovering from PTSD, which means that I have a lot of tools and perspectives that are helpful in traumatic times. All around us today, people are experiencing not just physical but emotional anguish that may be traumatic, whether directly from COVID-19 or from the effects it's had on our lives. And maybe something I say here will help you figure out a new way to cope, or to feel less alone.

I've never talked online before about the fact that I have PTSD. I don't think it'll be a huge surprise to many of you who've read my books, especially if your favorite of my books is Bitterblue. If the term "PTSD" makes you think, oh no, she's going to tell us a terrible story from her past and I can't deal with that right now — don't worry, I'm not. If it makes you think, oh no, she's going to start telling us what it's like to live with a terrible mental illness — don't worry, I'm not going to do that either :o). This post is simply about normalizing the struggles I, and maybe you, are facing right now. It's also about how we're more resilient than we feel. Because we are. Believe me. I know.

Okay, so. Here's a list of some of the challenges I've been dealing with recently — in most cases, not because I have PTSD, but simply because I'm a human being :o). Many of you may be experiencing them too.

Irritability. By which I mean my own irritability, which can flare at the slightest provocation. It's often followed by shame, even if my external behavior is blameless, because I hate discovering that I'm being unfair in my thoughts, and also sometimes it frightens me how close I come to lashing out. How's your equanimity recently? Do you notice your temper flaring? Have you been lashing out? Are you getting trapped in the cycle of irritability and shame?

The impossibility of having the correct amount of contact with literally anyone. Never being able to be truly alone.… Combined with missing friends… Combined with weirdly too much time interacting with people on my devices… Combined with not being able to bear small talk, or interactions with the millions of people who are always outside when I go for a walk. What's your version of this? Is it some complicated combination of loneliness and not enough solitude? Is it plain-old, too much loneliness and solitude? Is it too many parenting responsibilities? We all have different circumstances, and most of us are uncomfortable with them these days.

Periods of elevated anxiety. For me, I've noticed that this especially happens if I need to go into an enclosed public space, like the pharmacy or the post office. A few of my friends have said that wearing masks comforts them; well, it does not comfort me. Wearing a mask sometimes triggers some setting inside me that tells me that if I'm wearing a mask, it must be the apocalypse and I should be terrified. I don't know if this message is coming from my brain's twisted logic or from some physical signal that I'm not getting as much oxygen as usual, or both — but it's not fun. Do you find yourself spinning into anxiety these days? Have you figured out what your cues are? Pay attention. Notice when the switch turns on and you become convinced you're not safe. When does this happen for you?

Physical pain. For me, fear and anxiety manifest physically in my body and cause the world's tightest muscles. Usually, I have the privilege of receiving regular massages for pain, but of course that's not an option right now. I hurt all the time. How does your body feel right now? Where are you carrying your stress? Are you maybe more tired than it seems like you should be? Are you not sleeping? How is your appetite? In times like this, sometimes I confuse hunger with anxiety. I get hungry and some internal gauge inside me is like, Danger! Danger! This body is starving to death! I think the world is ending, but really, I just need a snack. What are your discomforts lately?

Emotional regression. In recent weeks, I've noticed insecurities — resentments — doubts — arising that I literally have not felt in years. Is this happening to you? Where are these long-lost bad feelings coming from? Maybe they're finding the cracks that are developing in our senses of self as we're repeatedly drubbed by worry and bad news.

Sadness and grief. This is just a reality right now. It's a reality for any of us touched directly by COVID-19 or its consequences on our lives and livelihoods, and it's a reality for anyone capable of compassion and empathy.

Brief and rare periods of epic, anxious meltdown, during which I can think of nothing but my fear, escalate it beyond anything rational, feel like my world is ending, and desperately scrabble to find solutions to protect myself. This is the one item on my list that I suspect is directly about my PTSD, because for me, this tends to happen when something in the news touches on my own personal PTSD triggers. For example, one of my personal triggers happens to be: Narcissists who deny reality because the truth doesn't suit them, subsequently harming the people around them. As you can imagine, this has been a difficult presidency for me, and unfortunately the BS has dialed up during the pandemic. Another of my triggers: The reminder that I live in a world in which a woman can be forced into a life circumstance that’s 100% wrong for her, especially one involving her own body. A couple weeks back, I had an epic meltdown when news started coming in about conservatives in Texas and Ohio using the pandemic as an excuse to deny abortions to pregnant women. I could not bear what was happening to those women. Another trigger: The fear of losing someone. I think most of us can relate to that fear these days. I hope you're not suffering from epic, anxious meltdowns. But if you are… you're not alone. Also, it's okay. You're going to be okay. An epic anxious meltdown is something that happens to humans sometimes when a real-life circumstance comes too close to our most fundamental fears. That's a fancy way of saying it sucks, but it's pretty normal.



So. Here are some of the tools I've been consciously using during this pandemic. A lot of them aren't going to sound very groundbreaking. But I've fought hard to learn some of these skills; I've battled against the demons of my past to internalize them and make them part of who I am, and some of them have changed my life. Maybe one of them will turn a light bulb on for you.

Every night, I write down a plan for the next day. It includes as much or as little minutiae as comforts me. It can include both tasks and emotional goals. Here's what I wrote for today's plan: "Walk. Laundry. Shower. Make more banana bread. Write blog post. Read. ACTUALLY REST. Stretch. Make a plan for tomorrow." The last item on my list is always, "Make a plan for tomorrow." My daily plan centers me and relaxes my mind.

I've established a policy of immediately mistrusting my own temper. In the past few weeks, there have been only a couple times when another person has injured me and I've been justifiably angry. In those cases, what I felt was good, clean anger, almost relieving in its clarity. Every other time my irritation has flared? That’s my sadness/worry/sense of powerlessness trying to find a vent. And there's nothing wrong with feeling angry! But acting on my anger when it's not justified makes me feel TERRIBLE, so I'm working really hard to catch my irritability in a net of compassionate suspicion first, then figure out what to do with it. I actually have a reminder that comes up on my phone every morning at 9 AM: "You are stressed out. Don't let it make you mean." Phone reminders help me.

I try to observe my emotional regression with compassion and without judgment. Now is the time for insecurities and resentments to come out and hassle us — that category of emotions that wait until our defenses are down, then attack. I think of these emotions as sad, pathetic visitors that need some attention. They need a hug from me, they need to know that they're welcome, but it's important that I resist believing them. A lot of times, these feelings make me laugh. If it's a feeling I haven't felt in years, it's a moment for me to appreciate how much progress I've made. I try to treat it as an old frenemy who's allowed to visit and hang out, but who isn't allowed to convince me of anything.

I process with friends and/or my diary. I'm a writer. Writing out what's going on makes me feel, if not better, clearer and more centered — whether or not anyone ever reads it.

I create the boundaries I need. The world outside my house is full of nice people who aren't doing anything wrong when they try to interact with me, but I'm very sorry, I cannot right now. When I'm walking, I need to be alone. So I put in my headphones and I don't make eye contact, even if it's only me and one other person on a long, empty street.

I find something to look forward to. It is really hard these days to have anything to look forward to. Every fun thing is canceled. I'm tired of my devices. It's hard to focus on reading. TV is too emotional. You know what's emotional in a good way? Eating banana bread. Every night, Kevin and I have some banana bread, and every few days I make more banana bread. Banana bread is my happy place right now. It's important to have some little thing to look forward to.

I do familiar things. When there isn't a pandemic, I have an office outside my house that's a mile away. My walk there and back is part of my daily routine. These days, I'm working from home, but I still take a daily walk. At first, when the pandemic started, I looked upon it as an opportunity to explore the neighborhoods around my house in other directions. And then I started to notice that my walks were most centering and anxiety-soothing when I took my regular, everyday walk, the one that goes by my office. So that's become my daily walk again. Too many things are new and unknown right now. When I can, I keep my routines familiar.

I take news breaks and/or curate my news intake. The problem with taking news breaks is that constantly checking the news gives you this frequent hit of adrenaline and (unfounded) hope, then when you stop checking the news, that hit goes away, and you realize how tired and sad you are. But tired and sad is the honest truth right now, and sometimes acknowledging the truth can be relieving. Especially since certain parts of the news are triggering to me. I have very limited capacity for the voice, face, and stupid, asinine announcements of our president. So I put myself on a news break fairly often — or limit myself to news that doesn't make things worse.

I pursue reasons to laugh. Do you know the newscaster, Andrew Cotter, who has no news to cast, therefore he's been tweeting newscasts of regular things happening in the world around him? When's the last time you laughed?

I call my doctor for pain, and I medicate. Even though there's a pandemic, if you have a medical problem, you get to call your doctor right now. I talked to mine for a few minutes the other day about my pain, and she prescribed me some muscle relaxants. I also have a benzodiazepine (antianxiety medication) that I use occasionally. Benzos can be habit-forming, so you need to be careful, but they are one of life's blessings on bad days. A note here that a lot of people think there's something shameful about medicating for anxiety or other psychological problems. In fact, I grew up in such a culture. As someone who's lived on both sides, I can promise you that this attitude is judgmental and unhelpful. Thoughtful use of medication is a form of self-care. Don't let anyone make you feel ashamed if medication is one of the tools in your toolbox.

I make Skype appointments with my therapist and I do not cancel them. Skype therapy leaves something to be desired; almost everything about social contact during a pandemic leaves something to be desired. But my marvelous therapist is an important part of my support team, and even if I'm tired, grouchy, hate my computer, and would rather pretend to myself that I'm fine, I am going to call on my support team right now.

I cry. Not everyone can cry when they want to, and not everyone finds crying helpful. But I've always been a crier; I've always known crying is a strength, not a weakness (as our society likes to make us think). Every few days, I've been having a good cry. Remember to hydrate if you're crying!

I notice/pay attention to anxieties that are new, and remind myself that I'll recover from them. I've noticed that my body has internalized the message that groups of people are dangerous. I am pretty sure that once this pandemic is over and we are allowed to go out in the world again, my body is going to be a little slow to catch on. I imagine Kevin and me driving to a party and having to pull the car over briefly because I'm panicking. I imagine needing to leave the party early. I imagine this happening a few times… until my body has been through it often enough that it can readjust to a new understanding of what is safe. I know from experience that bodies adjust. Until they adjust, it's uncomfortable, exhausting, painful — it can be awful. But if this is one of your current worries, please know that it doesn't have to be a permanent cage.

I follow my epic, anxious meltdown to its source. This is the most upsetting step on my list, because here's the thing: On the rare occasions I have a meltdown, it's largely because legitimately unjust and terrible things are happening. Yes, part of the reason the president, for example, can cause me a meltdown is because he's a lot like someone who hurt me a long time ago. This is one of the classic symptoms of PTSD: when shadows of your past trauma arise, the past trauma can come back to you full-force. So maybe this is at play a little bit when the president sends me into a tailspin. But the truth is, this particular symptom doesn't happen to me that much anymore. I've worked really hard to recover from my past, and I'm at a point in my healing where I'm pretty good at separating a present reality from my past. These days, shadows hardly ever cause me meltdowns.

The president is able to trigger me now because he is actually a traumatic human being. I flip out because he is actually dangerous and terrifying. I'm not flipping out about my past; I'm flipping out about him. And he has always been an agent of destruction and hate. He hurts the immigrants we're meant to be protecting; he incites racist violence; he makes sexually violent jokes about women. Well, now, in this pandemic, he has a whole new way to hurt people. A whole new topic about which to lie, posture, preen, behave like a toddler, make it about him, and not care whom it hurts. If my past experience is contributing in any way to my response to this person, it's by giving me a crystal-clear view of what he is, and an immediate, gut understanding of how much psychological damage he is capable of.

It's better to acknowledge the danger than pretend it's not happening. Unfortunately, here and now, that means acknowledging dark truths. People define trauma in a lot of different ways, and it's up to the affected person to decide whether they identify as being traumatized. But if you are finding yourself traumatized right now by the consequences of his decisions, that is 100% valid. If you are traumatized by his very existence — because how can someone so damaging be so powerful and be allowed to throw pain around without consequences to himself? — that's also 100% valid. I also suspect that some people who believe in him today will realize someday what he was and how much harm he caused. That realization — of how badly and how long they were fooled — may be traumatic to them.

The part of my response to him that's potentially irregular is the anxiety trap. Not everyone who sees a terrible evil is necessarily going to enter a state of physical anxiety so elevated, they can't figure out how to get out of it. But some people will. Honestly, it's hard for me to see it as irregular or irrational. Why shouldn't it be rational to shut down when something is horrifyingly unthinkable? But I do like to avoid a meltdown when I can, because it's too consuming while it's happening. Therapy has helped me with the process of learning to deal with this, tremendously. A pandemic is a great time to look into getting therapy :o). Therapy can be expensive; there may be resources near you that make it less so. In fact, one of my loved ones who's a mental health professional just informed me that some USA insurers are currently waiving co-pays for services including mental health — it might be worth contacting your insurer to see if they're doing so. In case it's helpful, here's a list, alphabetical by insurer, of policy changes during the pandemic.

I give myself a break. There are times during this pandemic when I just can't. Can't anything. I need to get under the covers and not think or talk or do anything. I'm privileged to be able to do this; I don't have children or other dependents, I'm not a healthcare worker on the front lines, if I get under the covers, nothing bad happens to anyone. But whenever you possibly can during this time, give yourself a break. Don't expect too much of yourself. Allow yourself to be unable to function. Allow yourself to be cheerless and hopeless, if that's how you feel. Forgive yourself.




I really, badly hope something there is helpful for someone.

One more things before I go. If this pandemic passes, but you notice that you or someone you care for is still struggling a lot... seek help. This situation is creating anxiety, PTSD, and other kinds of psychological suffering in people all around us. Here's some information about what causes PTSD and how to recognize it. Guardians and caretakers in particular — you can't prevent the stress of this time from negatively impacting your kids. It's not your fault if they are struggling with reality, and there's nothing to be ashamed of. But they are going to need you to see their reality, step up, meet their needs, and support them. And don't forget yourself! Get the care that you need too. Talk to your doctors and schools and look into therapy support around you. Therapy can be expensive, but there are organizations that try to make it affordable; maybe there's one near you.



Hang in there, everyone. You're exhausted, anxious, and sad because you try hard and you care. Until next time -- ♥ ♥ ♥

Future banana bread.

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James Max, the FT columnist, takes questions from readers about the misery of household chores

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Tiny droplets of water make the bugs take on an altogether different look - looking inflated by the covering of liquid.

CRAIG BROWN: Ann Ziety is the author of Just Relax and I Said, Just Relax, Weren't You Listening?'. Here is our first extract from her forthcoming bestseller, Coping With Lockdown.

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Careful planning, adequate budgeting and close cooperation of government and NGOs will be needed this summer in Barmer and nearby Thar desert areas of Rajasthan, says Bharat Dogra

Predictions of dire consequences from climate change are not new. For some communities, however, it is already too late to ward off the changes, and their only hope lies in adapting. Darryl D'Monte reports on a conference at which scientists and NGOs discussed such adaptations.

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Cham : Springer, 2019.

'The sleeping hours and the eating frequency have increased. But it's a phase of life, so it has to be taken in one's stride.'

Never one to complain about her circumstances, Preity is making the best of her prolonged isolation in Los Angeles.

Browsery R118.R24 2018

Dewey Library - PS3576.U24 L55 2019

Online Resource

Online Resource

Online Resource

Kipfer, Markus H, author

New York : Springer, [2007]

“It’s OK to feel scared and sad. And it’s OK to say so,” one Ph.D. student advises