Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
SPK Blog Post
How to Create Google Charts with Python
The goal of a typical system administrator is to get a job or task done as quickly as possible, without worrying about how elegant a solution might be. Reusing any existing scripts, tools, or utilities are always the first line in tackling the job. Often times, the...
Using IBM Rational Packaging Utility
In this post, we talk about how to use IBM Rational Packaging Utility along with Installation Manager to first create an installation package containing multiple products (in this case ClearCase and ClearQuest 7.1.2, and License Key Administrator 8.1.1). Then we will...
Reverse Proxy Configurations
Now it's time to look at some of the server side configurations. The first step is to configure reverse proxy for the HTTP services. These services live on hosts that sit in the DMZ. A proxy is very simple to configure and allows a lot of flexibility to grow over time...
CAPA: A Review of 21 C.F.R. §820.100 and FDA Warning Letter Trends
SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends. One of the problem areas most often cited in company audits continue to be the CAPA system/program. This month we will take a look at some of the latest FDA...
Enterprise Backup – Using Bacula to save time and money!
One of the main areas SPK focuses on for our clients is backups. I won’t go into a long lecture about why backups are mission-critical for your business because you already know they are. Even the standard backup schemes, such as Grandfather-Father-Son, have been...
Using Windows ClearCase Variables – CLEARCASE_PRIMARY_GROUP and CLEARCASE_GROUPS
Windows ClearCase has a couple of very useful environment variables - CLEARCASE_PRIMARY_GROUP and CLEARCASE_GROUPS. These variables can be a bit confusing at first blush, but they turn out to be rather important for controlling access to VOB elements, and creating...
Firewall HA setup with Juniper NS50s
One item I’ve done repeatedly while doing network consulting services is configuring high availability (HA) networks. The recommended way is Virtual Router Redundancy Protocol (VRRP). This requires that you have two firewalls for every location and they run in...
How to Authenticate Linux Users using Active Directory
In my previous post regarding wireless security, I mentioned that a single source of authentication for users is the most ideal in a corporate environment. The advantages of using one source for authentication are vast. One of the biggest advantages is that users only...
Computer System Validation: A Closer Look at 21 C.F.R. §820.70(i) and FDA Warning Letters
Avoiding 21 C.F.R. §820.70(i) FDA Warning Letters
Using the New ClearQuest Eclipse Client
Have you noticed that Rational ClearQuest 7.0 now comes with a new default Eclipse client? Wonder what is happening to the old Windows client and what the difference between the two is? Then this post is for you! Download the attached PDF file below to get the...
Security layers on a modern website
Last time, we looked at a basic website design. Now it’s time to start digging into the details around what’s really being used behind the scenes. This time, we’ll focus on security aspects. When a user starts their browser and connects...