En savoir plus sur Dot Compliance

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En savoir plus sur Dot Compliance

Avantages :

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 :

We are working with minor bags in the system, due to configuration mistakes.

Dot Compliance - Notes

Note moyenne

Facilité d'utilisation
4,0
Service client
4,2
Fonctionnalités
4,1
Rapport qualité-prix
4,0

Probabilité de recommander le produit

8/10

Dot Compliance a reçu une note globale de 4,5 étoiles sur 5 d'après 22 avis d'utilisateurs publiés sur Capterra.

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Bella
Bella
Computerized Systems Validation (Israël)
Utilisateur LinkedIn vérifié
Produits pharmaceutiques, 201-500 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

My Review for Dot Compliance

5,0 il y a 3 ans

Avantages :

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

Inconvénients :

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

Ferhat
Project Manager (Turquie)
Machines, 11-50 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

Flawless Compliance with Dot Compliance

5,0 il y a 2 mois Nouveau

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

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.

Corinne
QA and QC manager (Israël)
Biotechnologie, 11-50 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

Promising sometimes disappointing

3,0 il y a 3 ans

Commentaires : frustrating

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

Jennifer
Senior Manager, Quality Assurance (Canada)
Produits pharmaceutiques, 201-500 employés
Temps d'utilisation du logiciel : plus d'un an
Source de l'avis

Most Comprehensive eQMS on the Market!

5,0 il y a 3 mois

Commentaires : 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.

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 : Jira, CQRM XD Quality Management, HSI Donesafe, Cority et QCBD

Pourquoi passer à Dot Compliance : Dot Compliance has all the Quality Management System functions as well as electronic forms and batch records. It was the most complete system. Lastly the price of the system was the best.

Réponse de l'équipe de Dot Compliance

il y a 2 mois

Thank you very much, Jennifer, we really appreciate your comments across the web! We are glad to hear you are happy with Dot Compliance QMS. In our next update, we'll introduce you to our new & improved reporting capabilities :) Thank you again, Jennifer. Kind regards, Adam Rona, VP of Product

Arnan
Consultant (Israël)
Produits pharmaceutiques, Auto-entrepreneur
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

A very versatile QMS which was built by knowledgeable people

5,0 il y a 3 ans

Commentaires : 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.

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.

Alternatives envisagées : Agile PLM

Pourquoi passer à Dot Compliance : Ease of use, quality processes understanding, local support, knowing the people behind the system

Lilya
QP (Israël)
Produits pharmaceutiques, 11-50 employés
Temps d'utilisation du logiciel : plus d'un an
Source de l'avis

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

4,0 il y a 6 mois

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

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)

Réponse de l'équipe de Dot Compliance

il y a 5 mois

"Dear Lilya, We are very sorry to hear we didn't meet your expectations. We continuously work on product improvements such as regulatory submissions. Our support team is expanding to help respond quicker to customer inquiries. Regularly scheudled webinars & free online trainings are available to all users. Best regards, Adam Rona, VP of Product"

Steven
Chief Science Officer (Canada)
Médecine douce, 51-200 employés
Temps d'utilisation du logiciel : plus de deux ans
Source de l'avis

Canadian cannabis production and sales

4,0 il y a 11 mois

Commentaires : 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.

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.

Réponse de l'équipe de Dot Compliance

il y a 5 mois

Hello Steven, We appreciate your feedback! We have recently enhanced the Investigation process, thus not requiring you to enter the details both in the Investigation & the event itself. In addition, we have expanded our support team in the US for a more efficient communication pipeline. Kind regards, Adam Rona, VP of Product

Orit
QA Director (Israël)
Produits pharmaceutiques, 11-50 employés
Temps d'utilisation du logiciel : plus d'un an
Source de l'avis

Dot Compliance recommendation

5,0 il y a 3 ans

Commentaires : 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.

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.

Doron
Doron
RA/QA (Israël)
Utilisateur LinkedIn vérifié
Biotechnologie, 51-200 employés
Temps d'utilisation du logiciel : plus de deux ans
Source de l'avis

DOT compliance review

4,0 il y a 5 mois

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

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.

Réponse de l'équipe de Dot Compliance

il y a 2 mois

Hi Doron, Thanks for your feedback. We reecently expanded our Support team to both Israel and the USA, thus improving the availability of our service as well as the response time. Our Lightning versions in past 3 years include new capabilities and new features, as well as UI improvements to make the use more accessible for the user In addtion the upgrade process have been reduced significantly and we urge customers to upgrade to the latest version. Adam Yona, VP of Product

Angus
Validation Technician (R.-U.)
Appareils médicaux, 201-500 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

Dot Compliance Review

5,0 il y a 3 mois

Commentaires : 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.

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.

Réponse de l'équipe de Dot Compliance

il y a 2 mois

" Hi Angus, Thank you for your detailed and uplifting review. We are making a lot of effort to provide our customers with extensive and responsive support services, as well as to constantly improve our system to be as user-friendly as possible. It is really gratifying to know that you are satisfied with these. I'm sorry to hear that the system implementation was not smooth Our 'Professional Services' team does its best to ensure a successful adaptation to the system already in the initiation of the project and additional training is available in weekly webinars and online training. Adam Yona, VP of Product

Yoel
QA Director (Israël)
Produits pharmaceutiques, 11-50 employés
Temps d'utilisation du logiciel : plus d'un an
Source de l'avis

Positive Review

4,0 il y a 3 ans

Commentaires : 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,

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

Alternatives envisagées : TrackWise

Pourquoi passer à Dot Compliance : good value for money.

Alona
QA Coordinator & Training Coordinator (Israël)
Produits pharmaceutiques, 11-50 employés
Temps d'utilisation du logiciel : 1 à 5 mois
Source de l'avis

My review

4,0 il y a 3 ans

Commentaires : Good potential - not enough performance. Sorry

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).

Michael
Senior Manager IT Quality (É.-U.)
Vétérinaire, 1 001-5 000 employés
Temps d'utilisation du logiciel : plus d'un an
Source de l'avis

Very happy with DOT compliance.

5,0 il y a 12 mois

Commentaires : 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.

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.

Réponse de l'équipe de Dot Compliance

il y a 5 mois

Hi Michael, Thank you very much for your uplifting review! Regarding the difficulty you mentioned, we have enhanced the template feature for documents that can help you manage the whole lifecycle, including non-pdf documents. Kind regards, Adam Rona, VP of Product.

Chantelle
Executive Assistant (R.-U.)
Santé, bien-être et fitness, 11-50 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

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

5,0 il y a 3 ans

Commentaires : 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.

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.

Santino
Student (Jamaïque)
Gestion de l'enseignement, 501-1 000 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

Dot Compliance Review

5,0 il y a 8 mois

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.

Réponse de l'équipe de Dot Compliance

il y a 5 mois

Hey there Santino! Thank you very much for your review, Residing on Salesforce platform does require us to follow salesforce guidelines but it also enables us to deliver to our customers, a fast, cost-effective, and ready-to-use solution with great development flexibility and many infrastructures and security benefits that come with SAAS platform. Best, Adam Rona, VP Product

Amy
Quality Technician (É.-U.)
Appareils médicaux, 201-500 employés
Temps d'utilisation du logiciel : plus d'un an
Source de l'avis

User-friendly

4,0 il y a 3 mois

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

Réponse de l'équipe de Dot Compliance

il y a 2 mois

Hi Amy, We truly appreciate your feedback. It is gratifying to know that you are satisfied with the accessibility of the system, as well as the service of our support team. DOT strives to constantly improve our base product for all customers. Thus, the customers' feedback on the system's functionality is a preliminary step for our Product team when designing new features and improvements. Adam Yona, VP of Product

Inbal
GCP compliance (Israël)
Produits pharmaceutiques, 11-50 employés
Temps d'utilisation du logiciel : plus de deux ans
Source de l'avis

Clinical Control Documents

4,0 il y a 3 ans

Commentaires : The document control and TMF (Trial master file) are easy to control and organize.

Avantages :

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

Inconvénients :

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

Utilisateur vérifié
QA Documentation Specialist (Israël)
Utilisateur LinkedIn vérifié
Produits pharmaceutiques, 11-50 employés
Temps d'utilisation du logiciel : 1 à 5 mois
Source de l'avis

DOT is a wonderful software for QMS, DMS, and TRMS

4,0 il y a 3 ans

Commentaires : It is a wonderful product supported by an attentive, knowledgeable, and customer-satisfaction driven team. The software meets our company's needs and the DOT support staff is always available and eager to help us resolve any issues.

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.

Sara
Compliance Specialist (Canada)
Produits alimentaires, 11-50 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

Dot Compliance

4,0 il y a 3 ans

Commentaires : QA and compliance related issues are resolved more efficiently.

Avantages :

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

Inconvénients :

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.

Alex
Sr Validation Specialist (Canada)
Produits pharmaceutiques, 201-500 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

Alex's Review

4,0 il y a 3 mois

Commentaires : good experience

Avantages :

clean layout makes dot compliance easy to use and navigate.

Inconvénients :

some features not available for quality processes

Réponse de l'équipe de Dot Compliance

il y a 2 mois

"Dear Alex, I appreciate your feedback and are happy you find Dot Compliance friendly & easy to use! We are continuously working on improving the user experience after collecting feedback from our customers. As for the broader quality process, the upcoming updates should cover these tools :) Kind regards, Adam Rona, VP of Product"

Vinodha
QA Manager (Canada)
Biotechnologie, 11-50 employés
Temps d'utilisation du logiciel : 6 à 12 mois
Source de l'avis

DCS review

5,0 il y a 3 ans

Commentaires : positive. Comprehensive system. Top quality

Avantages :

Detailed with all features required to efficiently manage a quality system

Inconvénients :

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

Derek
CEO (Canada)
Formation professionnelle et coaching, 2-10 employés
Temps d'utilisation du logiciel : plus de deux ans
Source de l'avis

Fantastic Easy to Use EQMS

5,0 il y a 3 ans

Commentaires : Great team, quick response times and an EQMS solution at a fraction of the cost of competing solutions.

Avantages :

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

Inconvénients :

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