New role, new EQMS system, what do I do?

How it all started...  

• I’m the new QA Director & I’m the system owner of our new eQMS
• The implementation project is very far along... 
• Also, this is my first time owning a system
• Not only that, we have a legacy eQMS in place that we’re transitioning from...
• We’re a North-American company & 3 sites will adopt the new system as part of this implementation, total 250 employees 

What do I do??? Fortunately Joe was there, a business analyst and project manager with a ton of experience in implementation and operation of IT systems within GxP environments. Also ITIL certified (I had no clue what ITIL stand for back then...!). 

So I asked him : Joe, to begin with, please give me your top recommendations to help me go through this?

(Joe's answer) 

1. The Team! You must assess the team and ensure you have someone assigned to cover all areas of the project : Project Management, Design and Configuration, Validation, Migration, Documentation and Training. 

Reference: Key roles and responsibilities in a SOLABS QM Implementation

2. Review the plan with the team and vendor to understand what's been done and what remains to be done. Make sure you cover deliverables that need to be created internally (in addition to those provided by the vendor). 

3. Carefully plan the transition towards operations and ownership. 

References: 

Client Specific Deliverables

Key roles for on-going operation of SOLABS QM

Great after a few meetings I realize I have a solid team in place and solid plan. But this team had more questions for you Joe... : 

First: In regard to our legacy system and data, would you please help us review our migration plan and provide recommendations? We have a TON of historical data having had this system in place for almost 7 years... 

(Joe's answer) 

Short answer...

Documents: Migrate only In Process (when applicable) and Effective versions of documents, along with metadata. 

Training Data: Migrate only current Training Records, along with Job Title Profiles (also referred to as Training Curricula).

Process Data (e.g. Change Control): Do not migrate historical data, close open processes in legacy system if possible, and if not migrate only open records. 

AQ Show 29 includes further information on the subject.

Second: We would like to integrate this new eQMS with our current ERP system. The vendor said they could do this for us & it’s easy to do. However, our current eQMS is not integrated so this is a new type of effort for us. Is there anything that you would like me to consider in terms of potential issues/project risks.

Especially timeline.

(Joe's answer) 

This is an area where you might want to consider a subsequent phase in the project, or prioritize what this integration means? I am a strong advocate for documenting requirements and being specific with what needs to be achieved. 

The phrase "integrate this new eQMS with our current ERP system" could have a TON of different meanings and knowing exactly what is intended is the first thing to achieve. A good business analyst could be helpful :-) !

Finally, as the system owner, aside from the routine maintenance of this new system, what are some key best practices that you recommend I adopt for the organization?

(Joe's answer) 

First of all ensuring those areas are covered and documented : 

• Change Control of the System
• User Access / Security / Admin
• Business Continuity
• Incident Management

I would add to this Periodic Review to assess System Access, review Changes and documentation and ensure the system is maintained in a Validated State. 

Thanks Joe!