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Leading life science companies trust TrackWise Digital to help improve the quality of their products and processes. This ground breaking cloud based QMS platform features out-of-the-box workflows built from over two decades of experience and offers integrated quality event management, customer complaint handling, document management, employee training, and more. TWD will help you to go beyond regulatory compliance, create actionable insights, optimize performance, and increase visibility.
Provider
Sparta Systems
Located In
United States
Foundation
1994
Open API
Unverified
Deployment
Cloud, SaaS, Web-Based
Training
Live Online, Documentation, In Person, Webinars
Support
24/7 (Live rep)
Pharmaceutical, biotechnology, and medical device companies.
Content Source: Trackwise Digital
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Trackwise Digital Reviews
Pros
TrackWise is a great product if you have the resources available to customize the product to your use and put some effort into developing it.
Easy to use, efficient, a great addition to any quality system.
Overall positive experience and excellent customer service.
It is implemented in user friendly platform, which increase the user adoption and allows SFDC admins to provide a better support.
Cons
Even those we can customize the software there are some out of the box features which we can’t customize, more flexibility is needed.
Complaints app makes compliant records a no-brainer.
I don't like the missing EMDR form data as subsequent EMDR forms cannot send only deltas so fields are left blank. H6 codes are a mess for both entering and reporting.
There is no design element to field placement in the GUI, fields are just lined up in two rows with no thought to use. Console did not work when first implemented, so we've never used it.
Most Recent Video User Review for Trackwise Digital
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Trackwise Digital Review: Great Platform for Quality Management
Tyler P.
"Not built for large scale use. Poor design."
Pros: I'm able to submit cases to the FDA. The gateway has improved and does not fail as often as it did at launch. It is integrated into our Complaints process in Salesforce so that we can push data collected by the Call Center directly into the EMDR. However, since these are supported by different groups, change to EMDR are not coordinated with the required changes in Salesforce necessary to support them.
Cons: I don't like the missing EMDR form data as subsequent EMDR forms cannot send only deltas so fields are left blank. H6 codes are a mess for both entering and reporting. Most every other field acts like a field. There is no design element to field placement in the GUI, fields are just lined up in two rows with no thought to use. Console did not work when first implemented, so we've never used it. EMDR numbering would have work better if based on the Parent number and using an Item number and Revision to create keys since. This would have allowed all Related EMDRs to group together under a single number for each Initial and all of it's supplementals.
Vendor Response
"TrackWise for CDMO"
Overall: Solid QM system, it does take time and effort to develop in to a robust system
Pros: TrackWise is a great product if you have the resources available to customize the product to your use and put some effort into developing it. It is built on the Salesforce platform so if you have a Salesforce supper user or developer they can do wild things with TrackWise
Cons: Out of the box TrackWise digital was a little limited and the in house team expected features that were not ready out of the box.
"It is a great tool validate and track important complliace quality management"
Pros: It does not allow you to close any case if it is not compliance
Cons: It is difficult to use or search for cases
"We were able to implement effective processes in a very short time using TrackWise digital"
Overall: Great tool that helped reduce paper work, improved trending and data analysis, lean workflows
Pros: TrackWise digital is a strong tool. You can use a single module or link vaious modules very effectively. TrackWise digital modules are very well configurable so they can be adapted quickly and easily to really fit to your requirements. Most functionalities can be adapted by your System Admin after initial training, so changes can be implemented independently and cost for support is reduced. TrackWise digital is build in a user-friendly way, so training needs for users can be reduced to a minimum. Based on the Salesforce Platform, TrackWise digital deliveres a very strong reporting fundtionality for all modules.
Cons: While the core TrackWise digital modules are very fexible, the functionality and flexibility of the Document Management System (DMS) and Training Management System (TMS) is still very limited. Within these modules, changes and adaptions need to go through the Sparta Team, so implmentation takes time. These modules cannot be adapted to your specific needs in the same way than all other TrackWise digital modules.
Vendor Response
"Easy to use, efficient, a great addition to any quality system"
Overall: Overall, trackwise has been a huge benefit to my company, allowing for crossfunctional record keeping and collaboration. The system has some minor bugs but ultimately does the job well.
Pros: Trackwise is easy to use and understand. I have had no trouble integrating new team members to the software, and it definitely helps us improve the quality of our records. If you know what you are looking for, finding anything within your quality system is easy.
Cons: Sometimes it can be difficult to view your tasks. Team members often have to follow up with emails to get things done, as the original reminder emails often get lost in the clutter. There needs to be a worklist tab that has everything including your records across different scopes for writing and approving. Other quality systems I have used have similar items.
