electronic data capture (edc) and or collection

  1. L

    Monitoring transmitted data from a bluetooth medical product

    I'm working with developing a wearable sensor product, which is transmitting its measured data over bluetooth. My questions is, how is the transmitted data usually monitored during immunity testing? Will the strong EM fields not impact the transmitted data?
  2. S

    Bench Marking Automated Data Collection

    I am a Automotive Metal Stamper. We have 22 presses ranging from 100 tons to 1,200 tons that run over 400 different dies. Each part has a specific set of operator gages used to monitor dimensions. There are close to 6,000 gages currently in use. They are a combination of go/no-go gages...
  3. M

    Paper Records w/ SPC - When can the paper go away?

    Hello - we are initiating spc into our daily production. Is there a guideline on eliminating paper records as long as data is entered into spc. thank you
  4. D

    Centralizing the Receiving and Storage of Electronic Customer Data

    I am looking to develop a procedure for the centralized recieiving and storage of electronic customer data (i.e. BOMS, CAD). Our company has several different sales people who recieve data and but I need to centralize it to one person. We have had instances where the data package we quoted is...
  5. S

    Electronic Record Retention per FDA Requirements - Electronic Data Capture (EDC)

    Greetings! I work for an Electronic Data Capture (EDC) software company serving clinical trials. Our record retention policy for customer data collected via our system mirrors the essential requirements of QSR and ISO. We just had a customer request that we destroy their data once the...
  6. B

    Electronic Record File Format (Pdf & Tiff) - Acceptance by FDA?

    Hello All, Not sure if this really belongs here or in the FDA forum but, we'll give it a try: In an effort to go green, and reduce the amount of paper we store, we have embarked on a program to capture digital images of our paper records. We have selected, installed, and validated a...
  7. K

    Measurement Equipment with Electronic Data Collection - What type to buy?

    I'm deciding between 2 suppliers for measurement tooling and data collection, I'll be measuring a bore diameter, 3 groove depths, and 3 groove locations. the grooves are located within the bore. Other requirements for this project are: Must upload to excel (or easily copy/paste) Must have...
  8. V

    21 CFR Part 11 Electronic Data Storage Requirements vs. Paper Records

    we have instruments which generate (typical HPLC analytic method) data. Now the data is processed & stored electronically; However, the calculations are done manually. (including raw data is printed out along with processing details); (There are appropriate backup and access control...
  9. A

    QMS and Computerized Software Compliance with Standards

    Hi, I'm very new to this forum and sorry if my posted question is not in correct thread. Anyway, The question I cannot find the answer is: what FDA, ICH or other acts, guides should my company's QMS comply with? The company I work for, is an ISO9001:2008 certified and thus has the QMS that...
  10. C

    Collecting SPC Data Electronically? CNC Lathes, CNC Mills and CNC Grinders

    I work in a job shop with CNC Lathes, CNC Mills and CNC Grinders. We are looking into starting an SPC program. I would like to not have the operators manually make a control chart or graph, I would like it to be electronically made using excel or other database. What are you guys using with...
  11. R

    Paperless Chart Recorder to Monitor Oven Cycle Temperatures

    Hi folks, We are looking at implementing a paperless chart recorder to replace our current paper based ones. I am looking for advice on the best ones out there at the moment, we will be using ours to monitor oven cycle temperatures. I have looked at a few out of the box units and from what...
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