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...
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...
Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
In my last post, I gave an overview of Bacula, the enterprise-level free backup software. For this post I wanted to dig into the software a bit more and show how simple it is to setup a weekly backup job. One of the first things we do at SPK when working with a new...
Improve Your Ability to Sell Software into Medical Device Companies – In this paper we will share five things you can do to make your software application more attractive to medical device companies.
This article reviews what an FDA 483 Observation looks like, some of the more common issues flagged in medical device companies, and how to respond.
In my previous blog post, I talked about how to setup NSClient++ for Windows which is very solid Nagios NRPE client. In this post, I'll describe how to setup some basic checks for your Windows server within Nagios and hopefully give you some ideas on what you should...
Nagios is a wonderful tool. However, there are limits to what you can do with it directly. As my colleague Brad discussed in a recent blog post, using NRPE is a powerful tool for Windows. For complicated web checks that require multi-step operation, we use: WebInject....
VMWare is wonderful for getting full utilization of scarce resource. However, if you're on a limited budget, affording ESX clustered hosts for all needs is overkill. Sometimes a free ESXi server is enough. In the latter, we ran into challenges doing backups. ...
DB2 is one of the best databases available today for the money and features. It also offers a relatively easy upgrade from 8.2 to 9.1 database versions. The primary issue was finding which level of DB2 that other application vendors all supported. The attached...
Traditionally, using a VPN (Virtual Private Network) to connect to a remote site has been a technical – and oftentimes troublesome – requirement. With the growing popularity of using “remote programmers”, I see requests for purchasing Cisco routers and Windows...
Software Development Lifecycle (SDLC): In our last article we discussed speeding up your build by leveraging tools such as Electric Accelerator. In this article we will discuss the process of Continuous Integration (CI) along with a customer experience utilizing...