Dot Compliance Reviews

The product is user friendly. The flows in the system are the best practices that are used in the pharmaceutical industry (21 CFR Part 11, Annex 11, GAMP 5).
Almost no adjustments (customizations) are needed.
The validation package is very thorough and comprehensive.
The software is stable almost without faults

The main problem for us is the use of Hebrew. Especially when using Hebrew and English together.

It is great to be able to use a system that has a complete quality management system and electronic batch record records, as well as forms. The system has an excellent chatter function that allows quick communication with individuals throughout the company. Another great feature this system has is the ability to link items, such as samples with batch records, batch records to change controls, or change controls to deviations, to name a few. Lastly, Dot Compliance has a very responsive and knowledgeable IT team and customer service team.

There are very few issues with the system, and since I started using Dot Compliance, they have updated the system to correct any functions that I did not like or suggested a way to work better. Currently, the only process that the system is lacking is reports regarding master documents.

Good documentation management system
allows an easy retrieving of document and features

1 the version we got is "one size fits no one" the system was obviously developed to be used by a large panel of users: medical device, drugs, biotechnology. In the end, some of the features are ill-fitted
2 no confidentiality level: once a document is approved it can be viewed and printed by anyone. Masterbatch records should be only available to QA but not possible. Some document s should be restricted: labels ..not possible
3 approval of investigation, deviations CC intermediate steps .... are possible without QA review
4 risk assessments are approved only by QA - do not require additional review by professional personnel
5 professional support is not enough GMP oriented
6 the writing interphase is not comfortable at all
7 why do we have to open an investigation for each deviation- everything is written in the deviation screen any way
8 why do we have to open an investigation for QA events-usually CAPA are opened directly
THe investigation feature is shallow and does not allow the review of essential criteria such as operator, materials, equipment training and qualification
advanced feature are too expensive or require one on one training
some of the feature are not described in the manual

Dot Compliance has made staying on top of compliance regulations fast and easy. I was able to quickly and easily keep track of all my compliance obligations without any hassles.

The only downside to Dot Compliance is that the interface is a bit clunky and not very user-friendly. It took me some time to get used to the features and familiarize myself with the program.

The system is user friendly even when the processes are complicated. There is a full integration between all modules so it is easy to get the connection between different activities. Connection can be by equipment, product, batch number and such. It is evident that the system was built by people who have deep understanding in quality processes of pharmaceutical companies.

There are some limitations due to the fact that the system is built on "Salesforce" platform but in most cases DOT can find a solution.

hermetic managment a lot of modules for E-QMS

PV and RA does not support efficient managment of documents
life cycle too long

Expensive

not user friendly for most users
no differention to "superlight" users (for training of staff)

1. My team appreciates the relational complexity of the software. If a new user is not familiar with Salesforce (as my team was not), there is a steep learning curve; however, Dot has developed good tutorial resources that facilitate implementation. Once proficient, the software is easy to use and, in plain language, it makes good sense.
2. Dot technical support has been excellent, which is a KPI particularly with a software provider. The addition of North America-based technical support can only enhance our opinion here.

1. There are aspects of the software that cannot be modified by Dot because they are set by Salesforce. One significant detractor for my company has been that Salesforce will not allow us to purchase (and rotate) individual Light User accounts -- if a given Light User only needs to access controlled documents (e.g. SOPs) infrequently, it is not cost effective for us to purchase Light User licenses for every Operations employee.
2. It is unclear in some instances as to why a push notification is automated by Salesforce, whereas in other instances there is no push notification.
3. There are redundancies in information required to complete Investigations. When root cause and conclusion are already entered for an Investigation that a user is looking to close, why does the system require this information be entered again when advancing the Life Cycle to the CAPA stage? This seems like a waste of time.

We use Dot Compliance for documentation. Training and Quality events management.
The system is being used by most of our employees on daily basis. The data which is available and retrievable in any time, support us in operational and quality discussions. We managed our quality events in the system efficiently. The integration to our process went very well and as planned, with the support of Dot Compliance team and Intec team.

I think that the integration of the software can be improved by given the option to correct bags and mistake in software configuration in the project scope. We are working with minor bags in the system, due to configuration mistakes.
The software is not friendly use, when you need to write a lot of information in the system , the system does not recognized that you type and is closed without saving your update. This is the main disadvantage of the system and user compliant.

Based on robust platform (salesforce), technical support is local (Israel-based) and responds relatively quickly.

"Classic" version is outdated and upgrading is resource-heavy.

The software leads you down a path of compliance. If you just follow the way they makers intend it to be used, you will never have a compliance issue.

Master Documents are sometimes difficult to import, especially if they start out in a non-pdf format.

- numerous aspects of the QMS are captured in one system
- easiness of use
- easy communication with other company employees

- i need to create completing procedures: forms and controls in order to meet regulatory expectations
the system is not complete in some aspects in regards to current regulatory thinking

The relations between the modules - all in one.

1. The life cycle of the document is non-efficient. The owner of the document doesn't receive the notification that the document is pending in "Feedback consolidation". QA needs to use report to monitor training status. The document doesn't become effective automatically when the training is completed. In general - I would expect it to be more simple, because as it set now - you have to work hard to promote the document in its life cycle (including the building of dedicated reports).
2. In the training module, there are several processes that just not good enough. If the document is obsolete you need to remember to cancel its related R&U requirement revision (!). If the training was defined with annual frequency - it will be created year after the creation of the previous one (not year after completion) and there is no process of monitoring of these records for training coordinator. The employee cannot see his exam to check which answers he didn't answer right. There is no option of creation of the Job Description that will be related to the employee (basic requirement).
3. In the risk assessment, there is no option to define risk mitigation actions with monitoring of their implementation and no option to perform retrospective risk review (the basic procedure).

Fast, easy to use, many customizable options. Support available.

Some screens have a lot of information on them and navigating can be tough some times. Training and experience remedy this.

The Master Document and Training modules are easy to use, both as a User and as an Administrator. The system is accessible on smartphone as well as a computer, so training can be completed and signatures can be obtained at any time. This has led to a higher compliance with mandatory training, especially for staff who spend a lot of time working off-site.

Email notifications are not yet possible right through the system, so we still have to communicate manually to staff when some things are assigned (i.e. assigning actions in Change Controls, Deviations, etc.). Email notification should be automatic whenever staff are assigned ownership of a report or action.

Very stable and user friendly software that has helped to make our critical record keeping efficient.

Dot Compliance has an excellent document management system and I expect that it will grow to become even better.

Very good tutorial resources are very helpful during integration.

Very good technical support from the team when any issues arise.

There are some restrictions due to the platform is built on Salesforce.

It is a user-friendly software, and the support team is helpful

Integration/implemetation was a challenge in the beginning as there were some requirements that our company expected of the product that were not there. The Dot Compliance team was easy to work with, however, and they worked with us to improve their product to meet customer needs

Easy to implement and use. Easy to manage and review the clinical trial documentation.

The sharing and permission setting - who can view/edit records need to be more transparent and easy to control.

DOT is extremely easy to use. I have used a number of QMS and DMS software, but I think DOT is the most intuitive and easy to navigate and adapt to our company's needs.

There are certain elements we wanted to incorporate into the PDF generated versions of our documents, but the system was not able to accommodate these changes seamlessly. In truth, it is a minor inconvenience, but still created a bit of a problem for us.

QA documentation is made easier by having all quality records in one place and paperless. Audit module is very useful to continuous improvement

SOP numbers are not on the display page along with the title. QE's or Deviations can not be advanced without creating separate Investigation Task. Some features (including QE's and Deviations) are a bit complicated to use with regards to Investigation and CAPA notifications to investigator.

clean layout makes dot compliance easy to use and navigate.

some features not available for quality processes

Detailed with all features required to efficiently manage a quality system

Not very intuitive to use in some cases, notifications system could be better

Simple to set up and easy to use. Built on the Saleforce.com platform which makes it scalable and intuitive.

There were some logical flow issues but the latest release resolved this issue.