My Review for Dot Compliance

Pros

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

Cons

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

Flawless Compliance with Dot Compliance

I have had a great experience with Dot Compliance. The software has been invaluable in keeping me compliant with all the necessary regulations.

Pros

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.

Cons

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.

Promising sometimes disappointing

frustrating

Pros

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

Cons

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

Most Comprehensive eQMS on the Market!

Dot Compliance QMS is excellent at tracking training, and creating detailed reports regarding open or closed training has been highly beneficial. In addition, due to the electronic forms and batch records, there is no worry about missing or illegible documents.

Pros

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.

Cons

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.

A very versatile QMS which was built by knowledgeable people

Once the system is on, using DOT compliance system reduce efforts of all activities. All the information can be found and manual or written and printed processes are no longer needed which saves time and efforts. The system takes care to follow after processes so things are not left behind or forgotten.

Pros

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.

Cons

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.

expensive, not user friendly for most users, support not immediate available,

there are other E-AMS sytems less expensive with customer servise available at immediate

Pros

hermetic managment a lot of modules for E-QMS

Cons

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)

Canadian cannabis production and sales

Dot has played a huge role in planning and organizing our QMS. Including the audit module has also been very beneficial in organizing supplier audits and site audits of potential partners. Despite the Salesforce quirks, we are generally quite satisfied using the software and its functionalities. The Light User license cost issue is a significant negative aspect for us.

Pros

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.

Cons

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.

Dot Compliance recommendation

As QA responsible in the company, the software improve our data control and data availability. The management of the quality issues is more efficient and available to all managers. The training is more organized and we could upgrade our procedure to the system procedure which is comply with regulation requirements. Quality management review is more efficient.

Pros

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.

Cons

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.

DOT compliance review

OK experience, depends on amount of customization done at setp.

Pros

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

Cons

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

Dot Compliance Review

It has been implemented poorly and has been poorly received by staff. This is no fault of the software or provider. But it will be a long time before this QMS is implemented and used comfortably by operators.

Pros

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

Cons

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

Positive Review

the overall experience is good, the company uses the system as part of our routine and it has become part of our DNA. we get good support when needed,

Pros

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

Cons

- 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

My review

Good potential - not enough performance. Sorry

Pros

The relations between the modules - all in one.

Cons

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).

Very happy with DOT compliance.

Our overall experience has been a good one. The number of groups within the company that utilize DOT has grown every year. People are very happy with their results and the learning curve is small. Many videos and documents are available for training.

Pros

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.

Cons

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

Most modules are easy to use - great support from the vendor

The modules available are extensive and are mostly easy to use once learned. The support from the vendor has been outstanding, right from the time we started learning the system and migrated our policies and procedures. They are quick to action issues and take on board our suggestions for updates.

Pros

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.

Cons

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.