Category Archives: Technology

12May/06

Don’t forget the Process in PAT

By Daniel R. Matlis  

Do an internet search on Process Analytical Technology and you will be bombarded with sites for companies selling sensors, software and systems claiming to meet FDA’s PAT requirements.
I’m an engineer, and I like gadgets as much as the next person, but technology ought to enable change, not drive it.
Today I see companies following two distinct paths to PAT; one is technological, the other philosophical.

The technological approach to PAT, calls for the implementation of dedicated PAT systems.  This approach generally revolves around a specific technology or set of technology products and relies on a “silver bullet” to achieve the benefits of PAT. This is often driven by sensing or process analysis tools such as SPC, process modeling and process optimization.

This approach often involves the implementation of dedicated data acquisition tools and historians to gather and analyze the data in an information-only, non-validated environment.

The second and more holistic approach requires the development of a PAT philosophy and process across the enterprise. This approach sees technology as a tool to achieving process excellence as opposed to the end goal.

It is founded on mining the vast amounts of underutilized data currently available in automation manufacturing systems, such as SCADA, CIM, Historian, Batch, EBR and MES, It also looks to systems such as LIMS and ERP to correlate process and market data to identify key performance indicators and key process parameters based on historical information. This approach mines the vast amount of existing raw data and transforms it into actionable information through deep process understanding and data modeling.

To achieve the benefits of PAT, Life-Science companies need to design, analyze and control manufacturing through timely measurements of critical quality and performance attributes of raw and in-process materials and processes with the goal of ensuring final product quality. 

Implementing technology before achieving process understanding is like putting the cart in front of the horse.

10May/06

RFID on Prescription Drugs

By Daniel R. Matlis  

On the May 9th issue of Information Week, Mitch Wagner provides some simple and elegant solutions on his article entitled “A Simple Fix For RFID Privacy

In a previous article Levi Strauss proposal to use RFID tags on their Jeans was condemned by privacy advocates. He states “I’m not sure what the heck they’re worried about. I mean, how can you be concerned about privacy protection for information that’s already written on people’s butts?”

Although people may not be concerned about RFID tags in Levi’s Jeans, they ought to be concerned about RFID tags on prescription drugs.

The Food and drug administration (FDA) has issued a report recommending the widespread use of RFID technology throughout the pharmaceutical industry by 2007. The goal is to stem the tide of counterfeit drugs currently available though the internet.

RFID will play a key role in securing our nations drug supply. I can see a day were RFID tags will be the electronic equivalents of tamper proof seals, allowing consumers to rapidly identify counterfeit and fraudulent drugs.

However, there are significant privacy issues that must be addressed.

Would you want anyone with a rogue RFID reader finding out which prescription drugs you are taking?

I certainly would not.

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?

28Apr/06

TBI is no longer TBD

By Daniel R. Matlis

In the early 90’s I was involved in a project called Total Business Integration (TBI). The goal was to implement integrated systems to run the all business functions efficiently and effectively.

The objective was clear; the team motivated and capable but the implementation was yet To Be Done (TBD). The missing link was technology.  I am a believer that technology can only enable change, not drive. However, without the mature technology needed to support and organizational transformation of this magnitude, the results cannot be realized.Today, I saw a glimpse of what is to come.  PTC (http://www.ptc.com/), announced that it has integrated Windchill 8.0 and Arbortext 5.2, delivering the first end-to-end technical publications solutions from a single vendor.This Integrated solution provides an integral connection between content and process management software and XML authoring and dynamic publishing software. The integrated product serves both Product Lifecycle Management (PLM) and Enterprise Content Management (ECM) needs.This class of solution would optimize the publishing process in Life-Sciences companies where complex content continually changes and must comply with industry and governmental regulations. In addition this type of system would enable applicable downstream output to be automatically regenerated and republished to the selected audience in the appropriate media.

This is the kind of technology needed to enable Total Business Integration.Can we take TBI off hold once and for all?