Category Archives: Business

04May/06

Should I Build or Should I Buy?

By Daniel R. Matlis  

If I had a penny for every time I’ve been asked this question…

A company is looking for a customer complaints/ CAPA system. They are considering Building it with MS Access or Buying an off the shelf product?

Are there any special issues with validating such a system compare to in MS Access?

Building FDA compliant applications on MS Access can be problematic. It is especially challenging to meet industry and FDA security requirements with Access as the back-end database.

From a compliance standpoint, building custom software requires you to develop all the documentation for you system from scratch. You must also perform unit, integration and system testing for the application before you move to the qualification of the system (all the Qs).

Compliant Management and CAPA are required by the FDA. As a result, there are a number of mature Commercial Off The Shelf (COTS) products widely used in the industry.

In this particular case I would recommend a BUY with two caveats:

First, make sure you assess and evaluate the vendor’s product to ensure it meets your business needs.

Second, you assess the supplier’s quality system and Life-Cycle practices to ensure they meet your standards. Make sure you perform this supplier assessment BEFORE you buy.

Build a tree-house, buy CAPA software.

02May/06

One Size Does Not Fit All

By Daniel R. Matlis  

My friends at MRO sent me an interesting whitepaper to review entitled “Understanding the Real Risk for Asset Intensive Industries”. In this Paper they make an excellent case for a Rational Suite of applications instead of a single monolithic system to run the enterprise.

I started thinking, we want our clothes to be a good fit, why not our software applications?

How did we end up with one size fits all software?

In the Late 80’s computers began to appear on desktops in offices, labs and shop floors in Life-Sciences companies.  Pretty soon servers had hatched under every department manager’s desk. These stand alone department servers run homegrown applications often developed in programs like Lotus123, FoxPro and Paradox. These applications were not always validated, and over time some grew to run entire departments. In the mid 90s Life-Science companies and the Regulators realized the extent of computerization in the industry. MIS departments were directed to take control over the IT infrastructure and bring order to the digital chaos.

The result was often the implementations of monolithic systems like MRP and LIMS. Although I believe that enterprise applications play a key role in today’s Life-Sciences Companies, experience has shown that “one size does NOT fit all”.

With the advent of Service Oriented Architectures and Web Services (what IBM used to call the universal business adaptor), it is now possible to seamlessly integrate best of breed applications that fit your business needs without increasing the total cost of ownership.

I’ll take those shoes in a 9 please. What’s your size?