Agenda of FDA Inspection

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).
·         Design Control / History File.
·         Risk Management.
·         Device Master Record (DMR).
·         Change Control of Projects.
Lunch
·         CAPA.
·         Complaint Handling.
·         Field Actions / Recall.
·         Incoming Inspections.
·         Purchasing / Incoming Goods/Warehouse Activities.
Day 3
·         Daily wrap up.
·         Device History Record (DHR).
·         Internal Audits.
·         Validation Activities.
·         Non Conforming Product.
Lunch
·         Quality control (in process and final inspections).
·         Packaging / labeling.
·         Handling / Distribution/ Shipping.
·         Final Release.
·         Identification and Traceability.
Day 4
·         Daily wrap up.
·         Calibration / Maintenance program.
·         Field service/Technical assistance.
·         Decontamination / Returned Products.
Lunch
·         Housekeeping (Cleaning, pest control, building maintenance).
·         Statistical Techniques.
·         Pending Points.
·         Inspector’s findings Discussion.
·         Closing meeting.

Recommend Computer Room Temperature

What temperature is right?

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 database management tool

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.

Difference for moving AP/AR transaction to history mode in Great Plain/Dynamic system

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.

HK-Shenzhen tech park in Lok Ma Chau Loop

Charles Mok e-Bulletin

The government announced this week that it will partner with Shenzhen to develop Lok Ma Chau loop into a innovation and technology park. While I agree that more land supply for R&D is positive, given the huge investment in infrastructure that our taxpayers will pay for, we have the responsibility to ask the right questions to make sure Hong Kong will get value for the deal and generate positive impact, not rely on empty promises — granting entry permit waiver for “verified” Shenzhen workers, criteria and requirements to the tenants in the park, strategic role that this massive project carries in relation to other planned R&D land use at new development areas in the New Territories.

Transparency and accountability must be ensured throughout. I demand the government to release more details of this project, especially the cost estimate of development and what will be included in the proposed tech park, such as the proportion of land reserved for e-commerce, data centres.  

Raspberry Pi Wireless Connection Control

Introduction

recently, I found a software to manage wireless connection under Raspberry Pi (i.e Lunix), it called wicd-curese. It is easy to install it by running the following command:

sudo apt-get install wicd-curses

However, it request to install quite a few other packages but those daemon run in the background.

After installed, you can run it with command:

sudo wicd-curses

Then, the following screen will display for your setup control:

wireless-control

  • Right Key “->” to Configure
  • R to refresh the list.
  • D to Disconnect
  • C to Connect
  • F10 to save

You must be capital such as [SHIFT] C to connect. If you get a message saying no networks detected press P  and type in wlan0 in the wireless interface field and press F10 to save.

It is also manages the connection so it will reconnect to any configured wireless access points if it drops out for whatever reason but it will also try to connect to any available networks.

You might have to press C to connect to the access point. If you were wired that will most likely kill the LAN interface and bring up wireless, so, be careful for network connection.

 

Hong Kong Tech Voucher now open for application

SMEs which operate in Hong Kong for at least one year can now apply to the Tech Voucher Programme (TVP). Subsidy up to $200,000 will be provided on a 2:1 matching basis. Funding areas under the voucher programme include: technology consultancy; purchase, rental or subscription of customised equipment or hardware, software and technological services or solutions.

Check out our info kit here and the official guidance note to know more about the TVP. I will closely monitor the implementation of the voucher programme and identify the areas for improvement. You are welcomed to write to me about any issues you see in the TVP.

Policy proposals to the government

The government is soliciting views on the 2017 Policy Address and 2017-2018 Budget and each year I will submit to the government a list of policy and funding proposals to elevate the sector growth and push forward the innovation and technology development in Hong Kong.

I have submitted a proposal comprising 20 key recommendations on 10 areas, including: IT Talents And Employment Support Programme to foster partnership between IT businesses and universities to train more IT specialists; $1-billion InnoTech Studies Fund; establishing Technology and Law Reform Committee, InnoTech & Economic Transformation Working Group; creating Startups Accreditation Programme, Digital Marketplace Trial to help startups and SMEs win projects; overhauling the STEM education; establishing a Smart City Sandbox for innovative developments; increasing land supply for technology development and more. Your views are appreciated.

 

IT人在工廠日記 – 飯店捉老鼠

此照片是我在一間大陸飯店吃午飯時拍下的,當時伙記們很落力地捉老鼠,完全沒有顧慮到在座客人的感受,但是大陸人也很奇怪,這好像是平常事,而我也跟其它客人一樣,留在座位觀看,只求老鼠不要躲過來便算,這就是大陸的生活。如果事情發生在香港,客人會奪門而走,而這飯店肯定要見報被投訴,可是在大陸,這便是一件很平常普通的小事。20161121_130709