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.