FDA査察において原本の提示は必要か?

筆者はしばしばFDA査察に立会うことがある。
その際に査察を受ける企業から、「FDA査察において原本を提示しなければならないか。」といった質問を多く受ける。
答えはNOである。

質問者の意図は、SOPや記録の原本(つまり署名や捺印したもの)は紙媒体であるが、電子版をスクリーンで投影した場合、サインのないものになってしまうという懸念である。

多くの場合は文書(SOP)や記録は電子で作成され、印刷した後に署名または捺印をしている。
したがって、ドキュメント管理システムやデータベースに保存されている電子記録には署名や捺印がないのである。

筆者が多くFDA査察に立会った経験では、原本であるかないかを問われたことは一度もない。
FDA査察において肝心なことは、要求された資料を素早く提示することである。
紙媒体を検索して提出するまでにFDA査察官を待たせるよりは、素早く電子で提示した方がはるかにFDA査察官の心証は良い。
万が一、原本の提示を求められた際には時間がかかることを断ったうえで、検索し手提示すれば良いだろう。
しかしながら、コピーの提供(つまり査察官が持ち帰る)を求められた場合には、必ず捺印または署名されたもののコピーを作成しなければならないので留意が必要である。

捺印と署名は何が異なるか?

またしばしば、「捺印を手書き署名に変更した方が良いか。」といった質問を受ける。
回答は出来る限り手書き署名にした方が良いであろう。

査察や監査においては、相手国の法律や慣習を尊重しなければならないといった暗黙のルールがある。
FDA査察官は、けっして捺印が好ましいとは思っていない。
なぜならば他人が捺印できる(すなわちなりすまし)からである。

手書き署名には優れた利点がある。
それはコピーをとってもスキャンしても原本と同等と考えられるというものである。
なぜならば、書体(筆記体)自体が本人性を証明するからである。
私事ではあるが、筆者は外資系企業に長年勤務していた。
その際に、上司のサインをFAXでもらっていたことを記憶している。
また現在でも外国の企業との契約は署名したものをスキャン(pdf化)し、先方に電子メールで送付し、先方が署名したものをスキャンしたものを電子メールで送り返してもらっている。
これで契約が成立している。紙原本は必要ない。

また、捺印の場合、例えば代表取締役社長が田中さんから鈴木さんに変更になっても、印鑑自体は変更しない。
しかしながら、署名の場合は、必ず変更しなければならない。
何故ならば署名は個人に特有であるからである。

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  316. If attainable, perform the exercise with a spotter or
    use security bars in an influence rack. This allows for proper activation of the brief head of the biceps.
    Broad grip EZ bar curl is a type of bicep curl train you do with an Ez bar.
    When following this schedule, we might execute it in month A and then transfer on to a month
    B max effort exercise schedule. Once month B is full, we would work
    again via the month A exercises to test for increases in energy.

    This signifies that as a substitute of the variation having
    a worthwhile carryover to a contest lift or athletic
    functionality, the athlete merely turns into higher on the particular variation.
    Then underhand (more generally referred to as the reverse grip) bench press is a grip place where the knuckles of your arms are going through away from you.
    The reverse grip forces you to tuck your
    elbows more which makes it extra of a horizontal carry.
    Some folks knock the bench press, saying that it doesn’t replicate
    anything we do in activities of daily living.

    Though the extensive grip bench press is a coveted lift by fitness center goers
    and aggressive athletes alike, the close-grip
    bench press is also a great energy and muscle builder.
    However, it does include an necessary limitation that might
    be extra significant to some lifters and not as essential to others.
    No worries.The dumbbell shut grip bench press is the variation for you!

    Load up two dumbbells with palms dealing with in the direction of each other and proceed to lower them to the bottom of
    your chest.Pause for one second before powering the weights back up.
    The slim grip locations many of the workload on the triceps for maximum muscle development.

    The objective is to have your arms close while gripping the barbell.
    In distinction, a wide-grip bench press forces you to keep
    your hands removed from one another, main to raised
    chest activation. To carry out the close-grip bench press,
    take the barbell from the rack and carry it, keeping your palms around shoulder-width apart or a bit closer
    than that. Exhale as you slowly convey it
    all the method down to your chest, keeping your elbows parallel.
    If you want to be taught more about close grip
    barbell press for growing your chest, triceps, and shoulders to realize a extra outlined upper
    body, then you need to read the entire weblog.
    One downside of the close grip bench press is
    that the slender grip increases the entire range of motion of the carry, limiting your complete power output.

    To target your back muscles, the deadlift in all probability isn’t the most efficient.
    Relying in your biomechanics and the place of your
    hips, the deadlift will predominantly work the legs (hamstrings and glutes in particular) as a major mover.
    Smallest portion of your chest, spanning from your clavicle to your
    shoulder. It takes up a really small area of your chest and is a quantity of instances smaller than your
    sternal head.
    You may have to regulate your bench-pressing type to fit your anatomy; here’s
    how. And if that also doesn’t work, a greater choice could be to ditch the barbell and
    go for dumbbells instead. The overhand grip pull-up is amongst the best compound
    workouts for the upper physique. There isn’t any better
    or worse grip for the barbell bench press, it simply is dependent upon your goals.

    Changing your grip on barbell bench press will permit you to hone in on totally different muscle
    tissue and work on weak areas or muscle imbalances.
    The major profit of coaching the chest from different angles is healthier overall muscle improvement, avoiding overuse
    accidents, and providing you with more variety in your training.

    This positioning allows them to play an important role in several higher physique movements.
    In this guide, we’ll break down the muscle tissue worked, dive into the right
    kind, highlight frequent errors to avoid, clarify mechanical variables, and compare the dumbbell
    versus barbell variations. A place for for people who believe that correct diet and intense coaching are all
    you should construct an incredible physique. Talk About NANBF/IPE, INBF/WNBF, OCB, ABA, INBA/PNBA,
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    advanced lifters, we ask that newbies utilize the weekly and every day discussion threads
    on your wants.
    This compound movement isn’t nearly tricep power—it’s
    a game-changer for enhancing pressing power, enhancing stability, and constructing balanced arm and
    chest development. Whether you’re aiming to push past plateaus or sculpt
    a stronger, more outlined upper body, mastering this exercise can take your fitness journey
    to new heights. Let’s dive into everything you should know to execute it flawlessly, reap its benefits,
    and supercharge your results.
    The feeling of your arms getting larger with every curl is a ceremony of passage,
    and no train delivers a biceps pump like barbell biceps
    curls. Moreover, creating robust triceps improves general upper-body power,
    enhances stability in urgent movements, and helps prevent shoulder accidents by supporting
    proper joint perform. The bench press is normally a difficult motion as
    a outcome of the truth that it’s a compound movement.
    Some quick kind tips would be to make sure your shoulder blades
    are back and down, like you’re making an attempt to place them
    in your again jean pockets. Have a average arch in your lower back, keep your
    wrists straight and push via your toes when completing the movement.

    As A Result Of you’re using extra muscular
    tissues during this compound train, you’re going to fatigue not simply the muscular tissues, but the nervous
    system as properly, meaning that the entire physique will
    have to respond to overcome the stimulus. This not solely trains your recovery
    capability, but may also transfer to different workout routines that you simply perform within the health club.

    If you find that you’re struggling with locking out heavy bench presses and overhead presses, then it could be time to add and program extra close-grip bench presses.

    In each the barbell bench press and barbell shoulder press the triceps
    must be robust as they play a serious role in lockout.
    More particularly, the triceps may be make or break as
    you pass that 90-degree range of movement with the elbows.

    The close-grip bench press is a barbell bench variation that’s used
    to bias and strengthen the triceps.
    But, what the barbell bench press does is construct energy
    that transfers over to things we do outside of the health
    club. Getting stronger is always better, and this train builds energy by
    the bucket load. This is why it’s necessary to not just default to using lifting straps for each set and every rep of shrugs.

    Strive to maintain your grip with out straps as much as possible
    and you’ll notice a huge enchancment in your grip power over time.

    It’s like the bench press’s cool, tricep-loving
    uncle who comes to each household reunion to indicate
    off these sculpted arms. The wide-grip barbell curl
    modifications the usual curl by shifting your arms wider
    than shoulder-width apart, emphasizing the biceps’ quick
    head. This change helps build thicker higher
    arms and challenges your grip and forearm energy greater than a
    normal curl. Whether Or Not performed with an overhand or underhand grip, this variation forces your biceps to work from
    a unique angle for enhanced biceps improvement.

    The second widespread mistake with the movement is attempting to
    raise too much weight. Typically, trainees raise the identical
    load as they do for the basic bench press and should shorten their range of motion to compensate.
    We suggest starting with 50 to 60 p.c of your bench press working
    weight and specializing in correct approach.
    The muscle’s main operate is to stabilize the shoulder joint, and the anterior deltoid head assists the chest and
    triceps with urgent the burden. While a close-grip press places much
    less strain in your shoulders, it’s nonetheless possible to injure them.
    Using proper close-grip bench press strategies, like a gradual and regular descent, may help
    prevent accidents. Good grip strength is critical to carry
    out the close-grip bench press properly, as you can’t rely on your shoulder strength as much.

    In conclusion, the shut grip bench press is a helpful
    exercise for concentrating on the triceps and inside chest muscle tissue,
    nevertheless it may not be the greatest option for everyone.
    It can put more stress on the elbow joint and be more durable
    to stability the load, and is most likely not as efficient at focusing on the
    chest muscle tissue as different variations. It can also be
    less appropriate for those with a limited vary of
    motion within the shoulders. It is important to consider these elements and choose the bench press variation that’s greatest
    suited to your individual wants and targets.
    The wide-grip barbell curl variation is among the many most popular and highly favored variations.
    With your palms gripping the barbell in a supinated group wider than shoulder-width, it’s accomplished.
    The extensive grip for a wide grip barbell curl must be barely wider than shoulder-width.
    In this weblog, we’ll explain tips on how to accurately do the wide-grip barbell curl, which muscles are being worked, the benefits of the train, and different ways to do
    it. You might not have realized this, but if you do an in depth grip barbell bicep curl, you’re primarily turning your torso into a mini preacher pad
    by bracing your elbows against your body. The entrance squat is a common squat variation used in Olympic weightlifting training,
    contemplating the position entrance squat energy plays within the clean and jerk.
    Nonetheless, this motion has great carryover with all different strength and traditional
    sports activities athletes.
    Decrease the barbell to the center of your chest, making
    certain your elbows are tucked in to your facet for the entire movement (flaring
    and widening your grip will bring in too much chest activation).

    If you’re new to strengthening this muscle group, you
    might need to use dumbbells as an alternative of a barbell to begin out.
    In this case, your palms will be facing one another as you hold the
    weights. The close-grip bench press could be carried out
    in multiple ways to accommodate your health degree. Maintain in thoughts that a spotter or smith
    machine is always really helpful for security with this exercise.
    The Close-Grip Bench Press is certainly one of the greatest workouts
    for constructing huge triceps. However, most individuals don’t get optimal outcomes
    from this movement as a outcome of their form is mistaken.
    Weight coaching workout routines, together with the closed-grip bench press, can elevate levels of testosterone and progress hormone.
    These hormones help restore your muscles and make them larger, and they additionally help you feel higher throughout the day.
    High close-grip bench press errors embrace holding the arms
    too shut together, flaring the elbows out too far, tucking the
    elbows too close collectively, and positioning the barbell too excessive up on your chest.
    To preserve correct form, you’ll wish to maintain your hands not nearer than six inches apart
    from one another. The elbows should be close to your sides and
    your arms shoulder-width from one another.
    Whether Or Not you’re chasing dimension, strength, or definition, these workouts will
    become your new favorites. The close grip bench press is a good train for anyone who
    desires to build strong triceps and improve their bench press.
    It can also be an excellent option for individuals with shoulder issues,
    as it might possibly assist reduce stress on the shoulders.
    Nevertheless, it may be very important notice that the close
    grip bench press doesn’t work the chest as much because the common bench press.

    A longer distance to your chest means a longer time
    under pressure and overall only a weaker complete efficiency with
    the amount of weight you can transfer. I wrote an entire article on tips on how to bench press with lengthy arms, together with some specific suggestions that you could
    start to implement immediately. The trick is actually to check out the lift, and when you can really feel your triceps engage, the grip might be good.
    I wrote a similar article discussing the benefits of the decline bench press, which you want to learn after this to grasp
    how completely different bench press variations can help you.
    One, you’ll have to set the barbell up in your rack at a height that you’ll be succesful of safely rack and unrack the burden while laying on the floor.
    Floor Press is essentially Shut Grip Bench Press but done on the ground.

    The core muscles embody the erector spinae, rectus abdominis, obliques, transverse abdominis, and obliques.

    Gripping and holding your barbell will problem and develop your grip strength, building greater, extra highly effective forearms
    within the process. Depending in your grip energy, you might benefit from using wrist straps
    for this exercise. One of the risks with barbell upright rows is going too excessive, which may increase the chance of shoulder
    impingement. Incorrect method can stop you from reaping
    the muscle-building benefits.
    For novices, it is important to begin with lighter weights and
    focus on mastering the essential movement. One modification is to carry out the exercise with dumbbells as
    a substitute of a barbell. This permits for a
    greater vary of motion and helps enhance stability and control.
    You can nonetheless load this up heavy, but it’s not going to be the same
    as your one rep max on a standard bench press. This will permit you to master the form and
    place along with your elbows nearer to your physique, so
    you don’t have any shoulder pain.
    Verify out my other article on alternatives to the bench
    press that can assist activate the higher pecs.
    Using an EZ bar—a shorter bar with a section that zig-zags—provides areas
    to grip that can relieve discomfort in your wrists. Its distinctive form lets you position your grip extra ergonomically.
    You can read more about this in our article Does the Bench Press Work Your
    Triceps? This is where most people end up having a tough time with the exercise.
    Ideally, your arms ought to be shoulder-width or simply inside shoulder-width apart, allowing for optimum muscle engagement
    without overloading the joints.
    Your setup may have your palms anyplace from 1.5 to 2x as wide as your shoulders.
    Proper setup and kind can permit you to put up some huge
    numbers if powerlifting is your factor. At the danger of being contradictory, whereas reverse grip rows ARE
    extra spine-friendly than different rowing variations,
    they nonetheless put a good quantity of stress on your decrease again. For this purpose,
    many private trainers avoid prescribing any bent-over row to their shoppers.
    It’s impossible to do reverse grip rows without using your core, which is the collective name for the muscle tissue of your midsection.
    It might be dangerous when you use too much weight or
    use an improper bench press hand position. For instance, if you usually raise 100lbs
    (50lbs on every side), begin with 35-40lbs on both
    sides. Add or subtract 5lbs from each side
    until you arrive at a weight you would possibly be comfy with.
    You should have the ability to preserve proper type all through the raise
    – that’s more essential than the quantity of weight you’re
    lifting. Begin by lying on the bench, together with your again straight (not arched) and your legs firmly placed on the bottom.
    Maintain the barbell whereas it’s still on the rack, maintaining your arms
    shoulder-width apart. The close-grip barbell press can be done in different methods to swimsuit your fitness level and
    your selection.
    This makes the close-grip bench press one of the best possible lifts for
    building larger shoulders. In reality, it could be
    even higher than the incline bench press and overhead press for bulking up our entrance delts.
    What’s attention-grabbing is that the close-grip bench press challenges your upper
    chest and shoulders at long muscle lengths—in a fully stretched position—which is ideal for stimulating muscle progress.
    That could, speculatively, make it higher than the incline bench press for bulking
    up your shoulders and higher chest. After all, the incline bench press cuts out the very bottom of the range of motion on the bench press, failing
    to provide us a lot of a stretch. While it’s tempting to load the barbell with heavy weights to speed up
    muscle growth, starting with heavy bench urgent can result in a
    breakdown in method and enhance the chance of injury.

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