May 17, 2013

Biennial Checkup: Is NetSuite Ready for Life Sciences Companies Yet?

Posted in Cloud tagged , , , , , , at 2:24 AM by Solutions2Projects, LLC

The number of ERP/MRP systems available to my SMB life sciences companies is pretty limited especially if they require process manufacturing functionality.  With more biotech companies choosing to be virtual and outsourcing to contract manufacturers (CMOs) and third party logistics companies (3PLs), the process manufacturing piece becomes less important so long as there is light recipe functionality to provide traceability when converting from one item (i.e. API) to another (i.e. bulk product).  This includes providing lot data such as expiration dates and lot statuses as well as electronic records and electronic signatures compliant with 21 CFR Part 11.

I had the opportunity to take a look at the latest offering by NetSuite at SuiteWorld in San Jose this past week.  It’s hard to avoid the billboards on 101 and the CFOs who hear about it and think they must have it for their respective companies.  Even a local, high-flying biotech was tempted but realized quickly that it didn’t meet the requirements.   I last looked at it two years ago and quickly realized then that not only was it not appropriate for most of my clients, but it was barely compliant with Sarbanes-Oxley requirements as well.

Some very smart and generous gentlemen at ERP Guru (http://erpguru.com/) not only showed me the software but talked through how it could handle some of the processes that are typical for my clients.  I scratched out a typical product flow along with data requirements and within the manufacturing offering, it appears that the assembly functionality could potentially be used.

Where it fell apart was with the lot control functionality.  Fields can be created to support the lot control elements but custom scripts would need to be written to perform such critical functionality as to ensure expired product wasn’t allocated to a manufacturing run.  There were other similar examples that led me to the conclusion that it’s just not there yet for life sciences.  Once custom scripts have to be written to meet basic, critical functionality, not only are we into a different GAMP5 software categorization from a documentation and validation perspective (which requires greater rigor and effort that my clients really can’t support or afford), but you begin to introduce complexity in ensuring the custom functionality actually makes good business sense.

Just as when I reviewed Microsoft Dynamics SL for a small biotech company and discovered within 20 minutes that the lot functionality was not there, it was the same with NetSuite.  Once I saw what wasn’t there, I stopped looking at the product.

This isn’t to say that NetSuite isn’t interested in working on meeting the requirements.  I met with an account executive and reviewed some of the basic requirements and what we typically look for when selecting ERP/MRP systems.  She seemed genuinely interested and I’ve committed to providing requirements and some case studies from other ERP/MRP implementations to help her put a case together for improved functionality in future releases.

Although I am generally opposed to cloud-based solutions for
critical systems such as financial, SCM, manufacturing, among others from a control perspective, it’s not something that can be ignored.  My clients have small or outsourced IT departments and really aren’t interested in hosting things in house which means they need externally hosted or SaaS solutions.

My hope is that NetSuite is interested in the SMB life sciences vertical and enhances their product not this year, but by the time I go back to SuiteWorld in another two years.

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