Title 21 CFR Part 11: Auditing

January 16, 2012 by · Leave a Comment
Filed under: Business, Compliance, Healthcare, Regulatory 
Auditing implementation details:

Auditing is part of the law required for part 11 compliance here is what the law says itself

e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying.

This essentially means you need to collect who is performing the action, what they are doing (record the before and after values), the date and time of the activity, a reason for the activity if not specified implemented in the module.

There are several other aspects of auditing required including time synchronization and unique usernames and passwords.  Without these two things the audit logs don’t really mean anything it is a holistic thing and this explains why it is so important!

It is really valuable to have auditing across the entire system so that you can confirm roles security and authorization levels as well.  Security logging, system access logging, and electronic signature logging are all required and useful for testing of a system as well.

Startup Success–How to hire great people.

January 10, 2012 by · Leave a Comment
Filed under: Business, Startup 

In my previous posts I have discussed how important people are to making a great startup, In this post I will outline the characteristics that I think make for great people to help make you startup or your business a success. 

I think the number one character trait in looking for great people is simple… Integrity.  If you think about it, this is a great characteristic and makes for easy decisions, but how do you know if a person has integrity?  This is the most challenging aspect of this requirement, however you can read how people respond to problems, you can examine a resume and look for any red flags that show lapses in integrity, but to start to answer this question lets look at the core qualities of integrity so we can unpack this and see if there is some guidance we can use to make this clear.




1 – Integrity is a concept of consistency of actions, values, methods, measures, principles, expectations, and outcomes. In ethics, integrity is regarded as the honesty and truthfulness or accuracy of one’s actions. Integrity can be regarded as the opposite of hypocrisy,[1] in that it regards internal consistency as a virtue, and suggests that parties holding apparently conflicting values should account for the discrepancy or alter their beliefs.


I really like the part where it is the opposite of hypocrisy, so we are looking for an honest and ethical person.  I would hope most people would have this virtue, but unfortunately this is most likely a rare trait.  Some things to consider,

a) Do they claim to know things but don’t know them as well?

b) Do they take credit for everything or offer to give credit where it is due?

c) Listen to everything they say, usually there will be very straightforward times, especially when you have them tell you a story about a time they had a challenge, or learning something new, these are revealing to the persons true nature.

d) Watch their behavior for kindness, and politeness

Lets say you found a candidate, here are the other qualities in the order of importance.

2 – Motivation is similar to passion and only if the person has integrity will there motivations be in the best interest of the company.  With the proper motivation everything else will fall into place, this is important to be sure the candidate has motivation as well!


3 – Capacity is in third that with the proper motivation if they have capacity they can then understand what is needed and why things are important, and how to make things improve.


4 – Understanding is impossible without capacity as you really limit your understanding if you have no capacity to understand!


5 – Knowledge is meaningless without understanding!


6 – Experience is blind without knowledge!

How strange this is, that usually hiring decisions are based on experience instead of the things that fall in place with the proper foundation!

Startup Success Tip–It is not about the technology.

January 9, 2012 by · Leave a Comment
Filed under: Business, Startup 

Building a business is not straightforward or easy, things that seem like common sense surprisingly are not the right choices for success.  Knowing that the goal of a startup is ultimately to make money, with this in mind it is a good thing to remind yourself about as you progress in making a startup successful. 

With many startups based on technology and solutions it is a big trap that you can fall into easily, thinking it is about the technology.  What really makes it work and successful is the core issue of solving a problem, making the pain go away, and possibly giving pleasure or all three.  I call these the three P’s

1- Problem : This is ultimately what you are solving the niche where you fit in.

2- Pain: This is the pain you are making less, or removing, where people most likely are willing to pay you money to make it go away.

3- Pleasure: The converse is that pleasure, bringing pleasure and taking away pain are almost the same, you can think of games or other interactions matching in this category.




Technology is important, it is the means to an ends, however there are so many technological solutions, that they are interchangeable in many ways, there is no one secret sauce people are solving problems and if for some reason you technology works, that is great but don’t think that is what it is about.

I think the key ingredient to a successful startup is knowing the technology is not key, but the people are!  People are what make technology work, and people are what it is all about, that and of course a solution and plan for making money!  Many large companies buy out startups not just for the company as a technological asset, but for the data, business establishment, and most importantly the people who executed correctly.

How do we find the right people for hiring, this will be coming up!

Stay Tuned.