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Hitachi HMA-7500 Service Manual
Ideal for testing electronic equipment and offers versatility with modular test probes, alligator clips, test clips and more. It is now required that all stakeholders upload submissions in a single. International Dormitory HMA is the only Academy that provides international dormitory housing on the island. Is it necessary to inform authorities that sequences are uploaded via CESP upfront? So not screw the dipstick into engine as checking. Remove the thermostat cover. When I first signed up for HMA almost two years ago now I tried it for a month then upgraded to the year long plan on auto-renew so I never have to worry about missing anything!

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How do I know the Submission has been delivered? How to Create a. How to Create a delivery file. How to Upload the submission. If the delivery file is prepared in advance can it be viewed before it is submitted to ensure it is correct?

You can view the delivery file at any time by downloading and opening the file in a browser, or through an editing tool such as notepad. MAA Numbers in the second step of creation of a delivery file: On the delivery file, can we submit paper dossiers as well. If so, which option should we select as submission type for veterinary dossiers? No other recipient agency has reported this.

Should we resubmit to all agencies, or just to the agency contacting us? If resubmitting only to the NCA with problems, please also give clear information as above. How should we handle this situation? What happens if you rename the delivery file? Your submisison will not be delivered if the delivery file name has been modified. What is the Delivery Log Feature? What should a Company Administrator see in Delivery Tracking?

If you are a Company administrator you will see all deliveries for your companies and users. What should a Standard User see in Delivery Tracking.

The CESP system is a delivery system and does not interpret any information in the submission or application form. XML Delivery file — Is this considered the submission file? Can you confirm that it is the last folder to be dragged into the Remote Server Files and Folder pane? If a user inadvertently brings over the XML file first, what are the implications?

After uploading my files via web based file transfer system status is Completed and verified the folders do not disappear Remote Server files and folders as shown in the demonstration but have to be deleted manually. Is there a problem with the submission? If the delivery file is still visible your submission has not yet been processed and you should not delete anything from the folder.

Once the delivery file is no longer visible and you have received the confirmation emails the directory structure should be removed automatically.

At this point all of the files have been uploaded. There is one known issue however when sometimes the empty directory structure remains visible , this just needs to be removed before you upload you next submission. A number of agencies will accept clinical trials through the system.

Please check the contacts section of the website for specific national requirements. Are we required to provide the CESP submission number the number of the downloaded xml file right? Correct, this will ensure that agencies will duplicate the submission in agency systems.

Please refer to the contacts section for specific national requirements. Can the CESP system be used for national submissions?

Can we submit scanned hard copy files through CESP. If so, which option should we select as submission type for veterinary dossiers. Yes, any type of electronic submission can be submitted through CESP which includes scanned PDF files, the "other e submission" option should be selected when creating the delivery file.

Please refer to the contacts section of the website for any specific national requirements. Can you please confirm that we are submitting eCTD or NeeS submissions at the sequence folder level ie, including the sequence folder? The system places everything uploaded into a designated delivery folder when you upload the submission, the delivery file should not be contained within the folder structure but should be in the root of the remote server after you have uploaded your submission.

Currently electronic applications have to be provided with originally signed paper cover letters and applications forms in most countries. Are these letters still required? Do specific national requirements impact CESP submissions more than other national requirements? And how will you manage when several NCA will ask for the same? The issue of national requirements are currently under review by the group, it is important to note that some agencies have a legal obligation to request a national requirement.

Where practice and possible, national requirements will be provided electronically through CESP to meet these obligations. Please refer to the contacts section of the website for specific national requirements.

Please refer to the contacts tab section for national requirements. Does the web-based option also provide confirmation emails from each agency? File and Path name Length. When naming your zip file we recommend to keep the name as short as possible. Please use the standard ASCII character set when naming all files and folders inside your zip file and also when naming the zip file. Do not use any special characters. The following list is an example of the characters that are not permitted by the system: If special characters are used the submission is at risk of rejection by the recipient agency.

This has been discussed within the POC group and agreed to see what companies submitted, we would suggest at sequence level for the POC.

How long does it take to be sent to the correct agency? Submissions once uploaded to CESP are delivered depending on size usually within one hour. This may vary depending on the size of your submission and volume of traffic on the System.

How should we make a submission for a Worksharing procedure, or a Grouping procedure concerning multiple MAs? How to upload correctly through CESP. The correct steps to upload through CESP are as follows: Upload your delivery file. How do i submit? Is it necessary to inform authorities that sequences are uploaded via CESP upfront?

Is there a recommendation for use like for FDA gateway when the size of the dossier is over a certain limit e. We have tested the system with uploads of up to 10GB. We do understand that it is possible for submissions to exceed this size. For large submissions the key issue I would assume would be the time that it takes to upload , from the user side , some organisations may have time out controls on browsers and other types of ftp clients. Once the dossier is uploaded can it be viewed by the company?

No, CESP is purely a delivery system. Some agencies have a portal with electronic databases to fulfill when a variation for a national procedure is submitted.

Is there a requirement for a parallel submission. This is currently under review but the consensus so far is that if CESP is used for delivery with a correctly structured dossier including a electronic application form then no other action would be required. Some agencies have a portal with electronic databases to fulfill when a varitaion for a national procedure is submitted.

In this situation are parallel submissions required? We have been contacted by an NCA asking us to resubmit because the submission was technically invalid. What should be entered into the procedure number field? What should you do if you have more agencies related to your submission than those involved in the current system? Will parallel CD submission still be required? Will the validation of the application be by the system? Will the agency still do a validation?

Won't this increase timelines if another submission needs to be submitted? The system will not carry out validation, the agency will still validate the submission on receipt, but companies should carry out validation prior to submission. CESP is purely a delivery system. It provides a fast and efficient method of sending and receiving company applications. ZIP and Submission Guidelines. Is a new account required when a user returns from leave after more than 12 months?

Can we log out of CESP even if files are still in the process of transferring — or should we wait for everything to transfer before closing the CESP application? EMA are currently active in a number of projects and due to resource limitations are not actively participating in the project. Do these specific national requirements really impact CESP submission more than other national requirements? Some agencies are legally bound to request additional information in respect of applications.

We are looking at each of these requirements to see if they can be incorporated or delivered through CESP on a case by case basis. Do we get an acknowledgement for successful sending? Yes, an email is sent to acknowledge it has been uploaded to the CESP server and a confirmation email from each agency that the submission was delivered. No, it will be optional for agencies to participate in CESP. How do you deal with Agencies not involved currently? Technical issues can be directed to cesp hma.

Will the national portals be replaced or will CESP be used in addition to these? It is envisaged that for agencies participating in CESP with national portal that each agency will review their requirement for a national system once the system is fully operational.

If a user inadvertently brings over the sequence folder twice, would they be able to delete the duplicate files? Yes, as long as the delivery file has not been moved to the cesp server. CESP is another mechanism to deliver submisisons. Is there a limit of upload size? No, we have tested this system up to submissions with a size of 10gb. Speed of uploading is the main issue but this is dependent on your available bandwidth. Where bandwidth is limited a suggestion would be to start the upload of the submission out of normal working hours and once uploaded you can then upload the delivery file the following day to initiate the transfer to the agencies.

But the decisions from the CESP team has to be followed right? The participating agencies in the CESP project have a monthly online meeting to discuss areas and topics that require clarification.

The consensus view is always taken with the exception where the consensus contradicts national legislation. Login details not working. When do files begin to officially transfer via CESP to the health authorities?

We notice that the bottom pane reflects files processing — we are unclear as to whether these files are actually transferring or whether the actual transfer begins after the XML delivery files is dragged over? Files begin to transfer as soon as the xml delivery file is uploaded to the CESP server.

This is why it is important to copy your ZIP file first. Once the XML is uploaded the files immediately begin to distribute to the required recipients. The delivery file and system are not currently integrated with any other system that provides that information. Will files be received by MAHs as well as sent?

Will it be possible to add an additional email address to the user account, we would like to have the confirmation of upload email delivered to our common mailbox? It is recommended that a distribution group be setup through outlook to allow for multiple emails.

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