Some of the companies who helped us to become a leader in this line of business

Some things about Soft Design you might want to know...

We, Soft Design, are doing business for almost 25 years providing software applications used to document and manage training related information helping companies to become and/ or remain compliant. Many companies / customers consider us to be one of the leading developers and application providers in this line of business based on our expertise and long-time, practical experience.

Short Overview

In 1989/ 1990, we developed and released a DOS-based software application named: GMP Trainer. To our knowledge and research conducted, there were only two other software companies marketing programs dealing with training documentation used to become and/ or maintain QS or ISO compliance.

1994, we redesigned the application extending its functionality for Windows 3.1 while changing its name to: SD Training Tracker. 1996, two years later, we added Windows 95 features.

Starting in the mid 1990s until the end of 1999/ early 2000, Interpharm Press in Chicago sold the very same application worldwide under the name of: Training Tracker.
1999, we decided to completely redevelop and rewrite the entire application to make sure that there will be no problems in regard to the so-called Y2K compliance: "Year 2000". To indicate is compiance status ,we renamed the application to: Training Manager 2000 (TM 2000). Each update and upgrade was mostly based on various feature requests and recommendations made by customers worldwide.

2005, we released an application named: CAP (Competency: Assessment & Performance), which was at that point the Web-enabled version of TM 2000 containing some additional features offered through/ or made possible by Web functionality. Today, Training Manager 2000 / CAP have an installation base of more than 700 in over 80 countries and nearly 90% of our customers belong to the pharmaceutical or medical device industry. We are very proud of the fact that 12 of the "World's Top 20" companies are using software products designed and developed by Soft Design.

Audits

During the late 90s and early 2000, we were audited many times and we never failed an on-site inspection and none of our software programs ever failed when being validated either by the purchaser or by a contracted third-party software validation company. Being audited many times, we realized that this is not only time-consuming but also very cost-intensive. It is a fact that almost all pharmaceutical and medical device companies have a staff of well-paid people trained in answering questions just in case the FDA comes to conduct an on-site audit.

Software development companies face a similar situation and have to hire two or three employees who know regulatory requirements and know how to answer questions in order to make sure that an audit does not fail, which could be devastating even if it was just the result of a technicality.

Based on our experience, not every audit-conducting company is becoming a customer and we found it to be greatly unfair to base software prices on a cost calculation where buyers who trust and believe in us haver to pay for costs occurred by others who did not buy. This was the main reason why we decided in 2002 to deny any future audit request. In addition, we also realized that the number of companies requesting on-site audits actually decreased drastically because we were considered to be a long-time, reputable business. Furthermore, the industry somehow recognized that having procedures in place does not guarantee product quality, effectiveness and usability. Existence of SOPs can be verified but not the fact whether or not SOPs are being followed.

Conclusion

On-site or vendor audits were mostly conducted following recommendations as made by regulatory agencies to verify the fact that development procedures exist, that these procedures are being followed (as far as this can be verifed after the fact) and that the application seller has a reputation justifying the assumption that any future support is most likely guaranteed. We gladly provide any information requested by interested buyers, we gladly answer any vendor audit questionnaire, we gladly send / mail copies of some of our development SOPs and any additional documentation that might be of importance but we do not accept on-site vendor audits any longer.