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.

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.

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

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.

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).

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.

Clinical Control Documents

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

Pros

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

Cons

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

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

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.

Pros

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.

Cons

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.

DCS review

positive. Comprehensive system. Top quality

Pros

Detailed with all features required to efficiently manage a quality system

Cons

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

Dot Compliance

QA and compliance related issues are resolved more efficiently.

Pros

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

Cons

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.

Fantastic Easy to Use EQMS

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

Pros

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

Cons

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