Data Migration Validation - AGILE to (ARAS) Innovator

[DRdon - 2011]

Hello All...Long time Cove reader, first time poster. I've stepped into deep mud and will all the brain grease I've observed here, I'm hoping you can help. Management just informed Quality that the schedule for going LIVE with (ARAS) Innovator is now 1/1/2011. We will begin migration of data from AGILE to Innovator asap.

I am hoping for help in finding a data migration validation protocol that you have used given this migration happens hundreds times or more a year. I really am hoping not to re-create the wheel per se. We are a Class IIb, ISO, CE mark medical device company so this protocol will be audited by the FDA and our ISO auditors in a future visit.

Thank you in advance.

DD

 

[Stijloor]

Hello All...Long time Cove reader, first time poster. I've stepped into deep mud and will all the brain grease I've observed here, I'm hoping you can help. Management just informed Quality that the schedule for going LIVE with (ARAS) Innovator is now 1/1/2011. We will begin migration of data from AGILE to Innovator asap.

I am hoping for help in finding a data migration validation protocol that you have used given this migration happens hundreds times or more a year. I really am hoping not to re-create the wheel per se. We are a Class IIb, ISO, CE mark medical device company so this protocol will be audited by the FDA and our ISO auditors in a future visit.

Thank you in advance.

DD

Can someone help?

Thank you!

Stijloor.

 

[raghu_1968]

Hello All...Long time Cove reader, first time poster. I've stepped into deep mud and will all the brain grease I've observed here, I'm hoping you can help. Management just informed Quality that the schedule for going LIVE with (ARAS) Innovator is now 1/1/2011. We will begin migration of data from AGILE to Innovator asap.

I am hoping for help in finding a data migration validation protocol that you have used given this migration happens hundreds times or more a year. I really am hoping not to re-create the wheel per se. We are a Class IIb, ISO, CE mark medical device company so this protocol will be audited by the FDA and our ISO auditors in a future visit.

Thank you in advance.

DD

We migrated our manual documents (SOPs, Testing procedures, formats etc.,) to QMS document management software.

For the verification of the activity we have developed a protocol with the following things (brief description of contents are below). You can also develop the similar thing if it is applicable to you.

1. Introduction and scope : Background for the need for (ARAS) Innovator and the purpose of the document- ie. data migration protocol.
2. Roles and Responsibility : Team’s roles and responsibility those who are involving in the data migration project which included ARAS persons also,
3. Plan: Plan of populating the application with relevant data to enable such systems to become operational, continue business, and provide access to cGMP data.
4. Data migration sheet : Title provided in the data migration sheet and its brief description
5. Sampling plan: Brief description about the sampling plan with reference to ANZI/ASQ Z1.4-2008 standard for statistical sampling. Samples shall be selected with the help of random number table.
6. Documentation : Reference to execution (recording) sheet of the protocol, which included how to handle deviations if exists.
7. Test script result: which contains total number of documents subject to migration, number of documents tested as per the sampling plan, status of pass or fail
8. Concusion: Final conclusion stating that the data migration activity is successful / failure.

Hope this would help.

 

[DRdon - 2011]

Thank you Raghu for your posting...greatly appreciated!!

DD