OhNo!©: Software for FDG Production Control

Overview

OhNo! is the only Laboratory Information Management System (LIMS) designed specifically for labs that produce FDG for human injection according to cGMP rules.

Featues

  1. Stock control - Managing stock in a radiopharmaceutical laboratory is non-trivial. Raw material for drug manufacturing must be received, quarantined, sampled, identified, examined, released (or rejected), labeled, stored, dispensed and disposed of – all according to established specifications. OhNo! anticipates these requirements and imposes a system of stock control that helps align your lab with cGMP regulations.
  2. Maintenance control - Similarly, equipment for radiopharmaceutical production must be regularly calibrated, cleaned, maintained and capable of repeatedly producing valid results. In practice this means tracking and scheduling many maintenance procedures - often performed by multiple people, sometimes off-site. Checking every label on every piece of equipment every few days won’t work. A spreadsheet might work if you have the time and resources to maintain it. Or you can let OhNo! manage the scheduling for you – that is what it was designed for.
  3. Data control - Consistent FDG production requires collecting, consolidating and analyzing the data generated during irradiation, production and Quality Control. OhNo! collects and organizes over 70 FDG production and quality control parameters and correlates them with stock information.
  4. Production control - FDG production labs often employ many different chemists and technologists to handle cyclotron operation, FDG production, QC and maintenance tasks. It simplifies scheduling and it is a cGMP requirement. However, it complicates stock handling, equipment maintenance, and record keeping. Don’t rely on the wisdom of the masses – keep control with OhNo!.
  5. Save time - Your job is to make FDG – on time, every time. You can’t do that if you spend your time managing inventory, scheduling maintenance or hand writing inventory labels. Let OhNo! look after those tasks so you can focus on the important stuff.
  6. Generate alerts - How alarmed do you want to get over your lab coat cleaning schedule? How about your laboratory's nuclear license? OhNo! lets you decide. Alarms can be a gentle reminder to you. Or they can be urgent email and SMS text messages sent to others when inventory levels or deadlines become critical. A final alarm will trigger when the inventory runs out or when a deadline expires. Define all alarms once, and they will repeat forever.
  7. Reduce waste - Ever have to pour perfectly good stock down the drain because it expired? Minimizing stock wastage is an easy way to improve your clinic's bottom line. OhNo! helps the purchaser (probably you) make better decisions by estimating inventory, showing consumption rates, and displaying historical reports of usage. Another source of waste is when the wrong item is opened. The oldest item must be opened next to comply with cGMP but it is not always obvious which one that may be. Let OhNo! keep track and you will always open the right one.
  8. 8. OhNo! and cGMP - At present US clinics manufacturing FDG must meet the requirements of the USP product monograph. It is expected that F18-FDG will soon be subject to FDA regulations. The proposed rule (21CFR212) is too complex to be described in this note. But, you can visit our website and click cGMP on the Features tab to download reports that review how OhNo! helps you comply with the USP and the proposed FDA rule.

OhNo! is proving to be a useful tool in FDG manufacturing labs. We are confident that OhNo! will soon become the standard in FDG production control. Please visit our web site www.2ssLab.com to download a full-featured 30-day free trial of OhNo!, complete with sample data and guided tour. Try it and see for yourself how OhNo! saves you time and money, and lets you concentrate on making FDG on time, every time.

OhNo!: Software for FDG Production Control
2nd Sight Solutions
303-5455 Balsam Street
Vancouver, B.C. Canada V6M 4B3
Tel: 604 266 2253
Toll free North America: 1 866 536 9921
Fax: 604 266 4724
e-mail:info@2sslab.com