Recently, FDA conducted audit to my company. FDA is known as Food and Drug Administration whereas US has FDA organization and China also has CFDA organization. Its official web site is https://www.fda.gov.
I would like to post their 3 days inspection agenda for your reference. To pass FDA audit is essential for export medical product; let’s well prepare for it.
Day 1
· Introduction
· Opening meeting.
· Introduction/Presentation
· Plant Overview (Warehouse, Manufacturing and Quality control areas).
· Tour on facilities.
Lunch
· Quality Manual.
· Company Organization Chart.
· Document Control / Records.
· Change Control of Documents
· Human Resources (job description, hiring, training).
· Quality System Management Review.
Day 2
· Daily wrap up.
· Environment Control (Clean rooms, ESD and other applicable).
General recommendations suggest that you should not go below 10°C (50°F) or above 28°C (82°F). Although this seems a wide range these are the extremes and it is far more common to keep the ambient temperature around 20-21°C (68-71°F). For a variety of reasons this can sometimes be a tall order.
How do you maintain the right temperature?
Purpose built server rooms are well insulated for fire precaution reasons and air conditioning is essential. In many companies however the maintenance of the air conditioning is separate from the running of the servers. If the air conditioning fails you might not be the first to know. You may even be the last.
Even if everything is working the temperature may fluctuate during the day, from season to season, and there is always the possibility of localized hot-spots around equipment giving off lots of heat.
Don’t be tempted to think that just because you have an air conditioning unit that is up to the job that you are safe. People working in the server room sometimes switch the air conditioning off and forget to turn it on again. Sometimes they leave doors open. Servers run hotter at some times of the day than at others, air conditioning systems sometimes run at lower power at night etc.
What if it’s night time, your air conditioning is running at low power, and your webserver suddenly starts to work hard because the west coast has woken up? Now your machine heats up and your air conditioning can’t cool it enough. Exactly this scenario has been know to happen. Many intermittent faults and slow downs can be traced to overheating.
Replacing old equipment can introduce a new set of problems. Newer machines run faster and often run hotter as well, increasing the burden on the air conditioning systems even more. If you’ve recently introduced new servers or modern switches, it might be time to examining your air conditioning unit to make sure it can still keep up.
Another thing to look out for is the scenario where you turn up the air conditioning unit during the day, in order to ensure the right environment in your server room, but then don’t switch it down during the night or weekends. During the day there might be a lot of activity into and out of the server room. The server room door being opened all of the time lets warmer air into the server room thus necessitating the air conditioning system to be turned up high. At night and at the weekend, without the same level of activity, you may be running up large energy bills for no reason.
How are you going to monitor the temperature?
You need to monitor the temperature in your server room all of the time, especially at night and weekends when nobody is around. A number of systems are available for this purpose, the Temperature Monitor range from OPENXTRA offer good products at reasonable prices. You need to measure temperatures at different points in the room to get an idea of where the hot spots might be. You need temperature measurement to be automated and reliable, so a network attached device is ideal. The device must support alarms, via a number of different methods like email or SMS. You should be able to set the system up and then be alerted when something is wrong.
Information Source: https://www.openxtra.co.uk/kb/environment-monitoring/recommended-server-room-temperature.html
SQLite is the primary database of python. SQLite is a simple and easy to use database. We can also easy to manage SQLite database by using SQLite Studio, which is a freeware and you can download from https://sqlitestudio.pl/index.rvt?act=download.
SQLiteStudio is a SQLite database manager with the following features:
Portable – no need to install or uninstall. Just download, unpack and run.
Intuitive interface,
Powerful, yet light and fast,
All SQLite3 and SQLite2 features wrapped within simple GUI,
Cross-platform – runs on Windows 9x/2k/XP/2003/Vista/7, Linux, MacOS X and should work on other Unixes (not tested yet).
Exporting to various formats (SQL statements, CSV, HTML, XML, PDF, JSON),
Importing data from various formats (CSV, custom text files [regular expressions]),
Numerous small additions, like formatting code, history of queries executed in editor windows, on-the-fly syntax checking, and more,
Unicode support,
Skinnable (interface can look native for Windows 9x/XP, KDE, GTK, Mac OS X, or draw widgets to fit for other environments, WindowMaker, etc),
Configurable colors, fonts and shortcuts.
Open source and free – Released under GPLv3 license.
In Receivables module, a AR transaction document is moved to ‘history’ status when the said document is fully applied and then the Paid Transaction Removal (PTR) routine is processed (i.e. run “Paid Transaction Removal” Option under “Routines”). It is different from AP, whereas In Payables module, a document is auto moved to ‘history’ status when the said document is fully applied.