About Dot Compliance

Dot Compliance is a provider of pre-configured 21 CFR Part 11-compliant quality management systems designed for businesses within the life science industry. Dot Compliance helps businesses achieve ISO 9001:2015 certification, providing tools to help teams manage compliance processes for document management, change control, training, supplier quality, and CAPA, risk evaluations, and more. Dot Compliance's range of solutions includes QMS Express, Compliance Xpand, and Enterprise Xact.


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10 Reviews of Dot Compliance

Average User Ratings

Overall

4.42 / 5 stars

Ease-of-use

4.0

Value for money

4.0

Customer support

4.5

Functionality

4.0

Ratings Snapshot

5 stars

(6)

6

4 stars

(5)

5

3 stars

(1)

1

2 stars

(0)

0

1 stars

(0)

0

Likelihood to Recommend

Not likely

Very likely

Showing 1 - 5 of 10 results

March 2020

User Profile Picture

Bella from Phibro

Verified Reviewer

Company Size: 201-500 employees

Industry: Pharmaceuticals

Time Used: Less than 12 months

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

4.0

Functionality

5.0

March 2020

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.

Reasons for Switching to Dot Compliance

Some of our sites had no other QMS system and one of our sites used an old document management system

March 2020

Arnan from 10AR - Sterile Engineering Solutions

Company Size: 1 employee

Industry: Pharmaceuticals

Time Used: Less than 12 months

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

March 2020

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.

Reasons for Choosing Dot Compliance

Ease of use, quality processes understanding, local support, knowing the people behind the system

March 2020

Corinne from Bonus therapeutics

Company Size: 11-50 employees

Industry: Biotechnology

Time Used: Less than 12 months

Review Source: Capterra


Ease-of-use

1.0

Value for money

3.0

Customer support

1.0

Functionality

2.0

March 2020

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

March 2020

Orit from Intecpharma

Company Size: 11-50 employees

Industry: Pharmaceuticals

Time Used: Less than 2 years

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

4.0

March 2020

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.

Reasons for Choosing Dot Compliance

The project offer was more suitable and compatible for our needs as a small biotech company. The project team was available in Israel. Project Time and cost

Reasons for Switching to Dot Compliance

We looked for software that give the solution for Quality System Management.

March 2020

Yoel from Steba Laboratories

Company Size: 11-50 employees

Industry: Pharmaceuticals

Time Used: Less than 2 years

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

4.0

March 2020

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

Reasons for Choosing Dot Compliance

good value for money.