Item: MasterControl Quality Excellence
Rating: 10
Author: Verified User

Overall Satisfaction with MasterControl Quality Excellence

Use Cases and Deployment Scope

We'll be transitioning our whole QMS/TMS to MasterControl Quality Excellence. This includes Deviations, CAPA, Change Controls, and SOP trainings. We are also implementing the use of Mx to create EBRs and this will create a more efficient way in managing the review and closeout process while minimizing errors, hence minimizing deviations.

Pros and Cons

Pros

Internally very well integrated system
Ease of use
Allows less manual inputs

Cons

Current effective versions of documents to be the first to show up on searches

Return on Investment

Increased time efficiency
Controlled role access on sign-off/review

Usability

Faster, simpler, and easier to use than our current mode which is paper based

Alternatives Considered

TrackWise and ComplianceWire

Ability for creating EBRs while connecting to training and QMS, as well as integrating ERPs, calibrations, and more in one spot

Key Insights

Do you think MasterControl Quality Excellence delivers good value for the price?

Yes

Are you happy with MasterControl Quality Excellence's feature set?

Yes

Did MasterControl Quality Excellence live up to sales and marketing promises?

I wasn't involved with the selection/purchase process

Did implementation of MasterControl Quality Excellence go as expected?

I wasn't involved with the implementation phase

Would you buy MasterControl Quality Excellence again?

Yes

Likelihood to Recommend

With our process being a more manually operated (cell and gene therapy), there are a lot of qualitative data that is documented that can't easily be categorized in some cases under simpler buckets. This is harder to trend and review in those circumstances since there is still a lot of operator subjectivity that needs to be reviewed.

Comments

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