Science & Research
Volume III - 5.6 TurboEIR
Section 5 - Analysts on Inspection
|EFFECTIVE DATE: 10/01/2003||REVISED: 01-30-13|
- 5.6.1 Introduction
- 5.6.2 TurboEIR Website
- 5.6.3 Using TurboEIR
- 5.6.4 Writing FDA-483 Observations in TurboEIR
- 5.6.5 Writing the Establishment Inspection Report in Turbo EIR
TurboEIR was implemented ORA wide in October 2002 to assist in the writing of FDA-483s and inspection reports. It allows the downloading of inspection assignments from FACTS into TuboEIR, creation and printing of FDA-483s and EIRs, transfer of EIRs between the notebook computer and a network server, and synchronizing TurboEIR data on the notebook computer with a network server. A TurboEIR helpdesk has been established to assist users. The contact phone number is 866-752-8233.
TurboEIR is a software program designed to standardize FDA-483s and Establishment Inspection Reports (EIR). TurboEIR software has been loaded on laptop computers which are assigned to an individual. The individual has a unique account set up on the laptop and the data is encrypted using Entrust software. In order to perform an inspection as a Lead Investigator using TurboEIR, the analyst is to have a laptop assigned to them with Entrust encryption and TurboEIR loaded. If the analyst is assigned a laptop with TurboEIR and Entrust encryption, he or she receives training and graduates from the training mode prior to using the program during an inspection. If the analyst does not have these resources, TurboEIR inspections can still be performed, but it is as a team member. TurboEIR will demand much more communication between the investigator and the analyst during the preparation of the FDA-483 and the EIR. Analysts now have access to Turbo Cite Viewer which lists citations in TurboEIR format and may be used to facilitate the preparation of the observations.
For each Objectionable Condition (FDA-483 Observation), TurboEIR calls for the inspection team to choose a "canned" citation, then describe the details of the situation. Each "canned" citation contains a paraphrase of the underlying authority. Usually it is a regulation from Title 21, Code of Federal Regulations, but sometimes it is simply a statutory reference.
TurboEIR has a very informative website. If the analyst plans to use TurboEIR, he or she should go to this website and review it prior to the inspection.
It is helpful to mark this site as a “favorite” when using the Intranet. This site should be reviewed before beginning a TurboEIR inspection. There are many topics of interest to choose from on this home page. See below.
Quick Reference Guides (These useful guides walk a person through the operation of TurboEIR. In many cases, this guide can provide insight or answers to a number of problems encountered when working in TurboEIR. This site is periodically updated.)
Get User Information (Frequently asked questions)
Contact the Turbo Team(Look up support phone numbers and email addresses)
Searchable Knowledge Base (Search technical support information and self-help tools for Turbo EIR products)
DownloadCenter (for use by RCC staff only - Find all Turbo EIR downloads, including service packs, patches, and updates)
Editorial Control Board
Citations (Search the citation database for information)
Citation Status Report(PDF 34KB)
Search Citations(Search for a citation or group of citations)
Contact Us (Report problems, local support, etc.)
Using TurboEIR has many advantages and is strongly encouraged by management for the purpose of writing accurate, consistent, and complete reports and documents. The use of TurboEIR by consumer safety officers and analysts on team inspections will also increase the efficiency of report writing.
126.96.36.199 Operating as the Lead Investigator
As previously stated, in order to perform an inspection as a Lead Investigator using TurboEIR, the analyst is to have a laptop assigned with Entrust encryption and TurboEIR loaded. If the analyst is assigned a laptop with TurboEIR and Entrust encryption, he or she receives training and graduates from training mode prior to using the program during an inspection.
In order to use TurboEIR independently or to initially receive the assignment in Turbo EIR, the assignment contains the following conditions or information:
- It is an inspectional assignment (Operation 11 or 12).
- The person accessing TuboEIR is to be the Lead Investigator assigned in FACTS.
- It is "Assigned" or "In-Progress".
- It has the correct FEI# in the firm field.
This is explained in the Quick Reference Guide under "How do I download my inspection assignments from FACTS to Turbo EIR?"
The Quick Reference Guide provides step by step instructions on how to:
- Download assignments from FACTS into TurboEIR.
- Add names to the inspection team.
- Create, modify and save an FDA-483 in TurboEIR.
- Print and amend an FDA-483 in TurboEIR.
- Start, work on, save, and print an EIR in TurboEIR.
- Complete an EIR in TurboEIR.
- Synchronize data.
This guide is periodically updated. Check Turbo on the Web for the most active revision.
188.8.131.52 Operating as Part of a Team Inspection
If the analyst is part of a inspectional team and another team member received the assignment as the Lead Investigator in FACTS and downloaded it to Turbo EIR, she or he is to add the analyst to the Inspection Team in TurboEIR. This is needed in order for the analyst's name and title to appear in the signature block area of both the FDA-483 and the EIR, regardless of whether or not the analyst has a laptop.
The analyst will find that communications between all members of the inspectional team are critical when using TurboEIR, especially with respect to developing the FDA-483 and writing the EIR. See Sections 5.6.4 and 5.6.5.
Once it has been established that TurboEIR is going to be used on an inspection, the analyst is to write observations in Turbo format regardless of whether the analyst has a TurboEIR laptop or not. Each team member who has a TurboEIR laptop can independently work on the FDA-483 on his or her own laptop. However, doing it that way calls for significant communication and coordination. Citations can only be used once and can be accidentally overwritten if both team members use the same citation. TurboEIR does not prompt the user if the user is about to overwrite a citation. It is in the best interest of the inspection team to discuss the preparation of the Turbo FDA-483 PRIOR to its initiation.
If a team member does not have a TurboEIR laptop, she or he can still participate in the development of the FDA-483. There are many ways to accomplish this. Analysts now have access to Turbo Cite Viewer which lists citations in TurboEIR format and may be used to facilitate the preparation of the observations. For example, some analysts write down their observations, locate the regulation in the CFR for each observation, and then find the CITATIONS on the TurboEIR website. This information can then be provided to the Lead Investigator for incorporation into the FDA-483.
Analysts should be aware some of their observations might duplicate manufacturing observations of the same violated regulation. In those cases, the observations are grouped under one citation. In addition, for many of the CFR regulations there are multiple citations to choose from in TurboEIR, since there may be multiple ways for a firm to violate a given regulation. Care is always taken in selecting the best citation for the violation(s) observed.
Please refer to "How do I create a FDA-483 for an inspection assigned in Turbo EIR?" in the Quick Reference Guide. This section also addresses other concerns that may arise regarding the issuance of the FDA-483. If the analyst has difficulty identifying which citation(s) have been violated, ask the Lead Investigator for assistance. Analyst may be referred to a Supervisory Investigator or the Compliance Branch for assistance as well.
If the analyst performs several inspections in a year, printing out the main or often used citations may be an advantage. It allows the analyst to read the citation on paper and discuss it with the investigator, whereas doing all on the computer can be more cumbersome at times.
Before the analyst begins writing the Establishment Inspection Report in TurboEIR, the FDA-483 is signed and issued. Only the Lead Investigator can initiate the EIR in TurboEIR. This is described on page 20 of the Quick Reference Guide. Establishment Inspection Reports generated by TurboEIR have a very distinctive look. There are a number of templates to choose from when creating the EIR including abbreviated or detailed templates for general, pharmaceutical, and medical device inspections.
Each template has predefined headers. These headers can be deleted or modified as needed. However, refer to IOM 559 and 549 regarding headings which are needed on medical device and pharmaceutical inspections. These headings are needed because of Memorandum of Understanding (MOUs) between the U.S. and other countries. Firm data will be imported from FACTS into the EIR. Also, the FDA-483 Objectionable Conditions are imported into the TurboEIR. The format should not be changed.
When the analyst is working in TurboEIR, he or she chooses the SAVE function and accepts the file name that is provided. DO NOT change file name or choose "Save As"; serious problems may result.
When working on the EIR in TurboEIR, the user is working in TurboEIR Word program. Do not confuse this with the MS-WORD program on the desk computer in the office. TurboEIR is a Word document which is launched through TurboEIR Field Agent and the files are automatically named. This allows the documents to be saved in a file which is linked to the TurboEIR database.
If the analyst prefers to work on the EIR before the inspection is completed, this is allowed, but DO NOT work on the document in TurboEIR. It is a separate Word document. Once the TurboEIR document is started, the user can cut and paste from Word into TurboEIR Word. This is also the case for analysts who do not have access to the TurboEIR program.
If the analyst is a part of a team inspection, only one person can check out the EIR at a time. Therefore, it is important to continue the communication during the preparation of the EIR.
Questions regarding TurboEIR are best directed to Investigators who frequently use the program or the help desk. The help desk can be accessed through the TurboEIR webpage.