Which Comes First – The Process Or The Solution?

By Christine Park, Quality Architech

I find this a fascinating discussion, similar to the old chicken or the egg question. Of course, it’s all about perspective. How can you determine what you should automate and the best approach for your business needs? I find the best approach is to understand your own business needs/requirements, how you want the process to work and why the specific solution you are considering will be best for your operations.

There are many excellent automated solutions for key components of the Quality System on the market. In fact, you can automate almost all major areas of your system with off-the-shelf software. The most common elements for automation include:

• Audit programs – internal, external and supplier. The automated solution for this element should allow you to analyze the audit data by audit type, regulatory/standard clause and/or specific nonconformance.
• CAPA (Corrective And Preventive Action)
• Complaint management
• Nonconformance/deviation management
• Training
• Document control
• Change management – revision control and management design, and/or manufacturing documents, as necessary

The automated solution should allow you to: