Dot Compliance

Avantages

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

Inconvénients

"Classic" version is outdated and upgrading is resource-heavy.

Avantages

User friendly, very intuitive. Easy process flows

Inconvénients

Setup is quick and resources should be assigned to maximise the benefit of the supporting Project manager

Avantages

Automated reminders for upcoming due dates (deviations, CAPAs, SOP revisions, etc.)

Inconvénients

It was confusing for some of the non-technically inclined members of our team.

Avantages

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

Inconvénients

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

Avantages

It has everything you need at your fingertips. Product is effective & user friendly.

Inconvénients

There isn’t a monile app version of the product.

Avantages

Dot Compliance's eQMS system for Salesforce has truly transformed our business operations, and I couldn't be more thrilled with the results. It has been nothing short of a game-changer for us, simplifying our administrative processes, ensuring compliance, and keeping us audit-ready at all times. ClientPharma owes a significant part of its success and adaptability, especially during challenging times like the Covid-19 restrictions, to this exceptional system. The way it has seamlessly integrated into our daily workflow has been remarkable. Having our documentation easily accessible and trainable has proven invaluable. It allowed us to continue our operations smoothly when remote work became the norm. One of the standout features of Dot Compliance's eQMS system is its effortless implementation. With minimal customisations required, we not only stayed within our allocated timeframe but also found the transition surprisingly smooth. It's a testament to the system's user-friendly design and adaptability.

Inconvénients

This is really nit picking, as there really isn't anything I don't like about the system, but, Salesforce limits Dashboards to 20 components and doesn't auto refresh.

Alternatives envisagées 

Pourquoi passer à Dot Compliance

Avantages

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.

Inconvénients

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.

Alternatives envisagées 

Pourquoi passer à Dot Compliance

Avantages

hermetic managment a lot of modules for E-QMS

Inconvénients

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)

Avantages

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.

Inconvénients

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.

Avantages

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.

Inconvénients

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.

Avantages

When I need to generate a protocol for execution, it's a straightforward series of steps. I can then quickly assign to the relevant signatories, and I can check on each person's progress any time I want.

When I have trainings due, they are very clearly indicated on my home page. I can easily access them so things stay completed on time.

Inconvénients

Sometimes it can be a bit convoluted to access certain forms. Once you have the workflow down, though, it's simply rinse and repeat for the next time.

Avantages

Ease of use and flexibility. excellent reports builder tool.

Inconvénients

I think the admin set of permissions is too little, which requires urgent calls to the service, even though the response is fast and professional, it is still an unnecessary burden.

Avantages

The product is good and easy to implement.The team is excellent, very professional

Inconvénients

The registration module need some improvements.Sometimes there are basic fields that should have been and do not exist, such as a field that makes it easier to see when the deviation was closed.

Avantages

User Friendly and linking between features

Inconvénients

A lot of approval and signatures are required

Avantages

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.

Inconvénients

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.

Avantages

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.

Inconvénients

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

Avantages

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.

Inconvénients

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.

Avantages

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

Inconvénients

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

Avantages

The relations between the modules - all in one.

Inconvénients

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).

Avantages

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

Inconvénients

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

Avantages

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.

Inconvénients

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.

Avantages

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.

Inconvénients

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.

Avantages

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

Inconvénients

- 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

Avantages

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.

Inconvénients

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

Avantages

clean layout makes dot compliance easy to use and navigate.

Inconvénients

some features not available for quality processes