Dot Compliance

Quality and compliance management for life science companies

4,4 /5 (12 reviews) Write a Review!

Dot Compliance Overview

What is Dot Compliance?

Dot Compliance is a platform that helps life science companies manage pre or post-market quality processes including CAPA, change control, training, document control, batch records, and more. Features include workflows, compliance dashboards, big data integration, AI, audit management, and more.

With Dot Compliance, users have access to pre-engineered and pre-validated quality management processes enabling cross-organization visibility, insights, and trend tracking for data-driven decision making. The platform uses machine learning, big data technology, and AI (artificial intelligence) to provide users with predictions and recommendations for quality management improvements.

The Dot Compliance platform ensures companies are audit-ready with features such as document management, training management, corrective and preventive action (CAPA), risk management, and supplier quality management. Additionally, cross-organization processes such as batch and design control, equipment and maintenance management, clinical trials, and enterprise application integration can be managed in the platform, as well as regulatory affairs and audit management.

Dot Compliance Overview

Pricing

Starting from
N/A

Pricing options

Free Trial
Subscription
Value for money

Contact Dot Compliance for pricing information.


Dot Compliance Features

Devices
Business size
S M L
Markets
United States, Canada, United Kingdom, Australia, China and 5 others, India, Japan, Germany, Brazil, Mexico
Supported Languages
English

Media

Dot Compliance complaints dashboard
Dot Compliance document control
Dot Compliance validation procedure
Dot Compliance screenshot: Dot Compliance complaints dashboard Dot Compliance screenshot: Dot Compliance document control Dot Compliance screenshot: Dot Compliance validation procedure

Dot Compliance Reviews

Dot Compliance Reviews

Overall rating
4,4
/
5
Excellent
6

Very good
5

Average
1

Poor
0

Terrible
0

Value for Money
4,2
Features
3,9
Ease of Use
4
Customer Support
4,3
92% recommended this app
Bella B.

My Review for Dot Compliance


Arnan B.

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.


Corinne C.

Promising sometimes disappointing

frustrating


Orit M.

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.


Yoel B.

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,


Bella B.
Industry: Pharmaceuticals
Company size: 201-500 Employees

My Review for Dot Compliance

Used Daily for 6-12 months
Reviewed on 2020/03/04
Review Source: Capterra

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.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 10.0/10

Arnan B.
Industry: Pharmaceuticals
Company size: Self Employed

A very versatile QMS which was built by knowledgeable people

Used Daily for 6-12 months
Reviewed on 2020/03/05
Review Source: Capterra

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.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 10.0/10

Corinne C.
Industry: Biotechnology
Company size: 11-50 Employees

Promising sometimes disappointing

Used Daily for 6-12 months
Reviewed on 2020/03/09
Review Source: Capterra

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

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 5.0/10

Orit M.
Industry: Pharmaceuticals
Company size: 11-50 Employees

Dot Compliance recommendation

Used Daily for 1+ year
Reviewed on 2020/03/04
Review Source: Capterra

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.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 9.0/10

Yoel B.
Industry: Pharmaceuticals
Company size: 11-50 Employees

Positive Review

Used Daily for 1+ year
Reviewed on 2020/03/03
Review Source: Capterra

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

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 8.0/10

User recommendation
8,3/10
Based on 12 user ratings
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Dot Compliance Pricing

Dot Compliance Pricing

Starting from
N/A
Free Trial
Subscription
Value for money

Contact Dot Compliance for pricing information.

Contact Dot Compliance for pricing information.

Value for Money
4,2/5
Based on 12 user ratings
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Dot Compliance Features

Dot Compliance Features

API
Activity Dashboard
Activity Tracking
Audit Trail
Auditing
Automatic Notifications
Billing & Invoicing
Compliance Management
Customizable Reporting
Data Import/Export
Document Management
Document Storage
Inventory Management
Inventory Tracking
Monitoring
Real Time Data
Real Time Reporting
Reporting & Statistics
Third Party Integration
Workflow Management
Features
3,9/5
Based on 12 user ratings
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Categories

Additional information for Dot Compliance

Additional information for Dot Compliance

Key features of Dot Compliance

  • Archiving & Retention
  • Change Management
  • Compliance Management
  • Controls Testing
  • Defect Tracking
  • FDA Compliance
  • Incident Management
  • Quality Control
  • Supplier Quality Control
  • Training Management
  • Version Control

Dot Compliance FAQs

Dot Compliance FAQs

Below are some frequently asked questions for Dot Compliance.

Q. What type of pricing plans does Dot Compliance offer?

Dot Compliance offers the following pricing plans:

Pricing model: Subscription

Free Trial: Not Available

Contact Dot Compliance for pricing information.

Q. What are the main features of Dot Compliance?

Dot Compliance offers the following features:

  • Archiving & Retention
  • Change Management
  • Compliance Management
  • Controls Testing
  • Defect Tracking
  • FDA Compliance
  • Incident Management
  • Quality Control
  • Supplier Quality Control
  • Training Management
  • Version Control

Q. Who are the typical users of Dot Compliance?

Dot Compliance has the following typical customers:

Large Enterprises, Public Administrations, Mid Size Business

Q. What languages does Dot Compliance support?

Dot Compliance supports the following languages:

English

Q. What type of pricing plans does Dot Compliance offer?

Dot Compliance has the following pricing plans:

Subscription

Q. Does Dot Compliance support mobile devices?

We do not have any information about what devices Dot Compliance supports

Q. What other apps does Dot Compliance integrate with?

Dot Compliance integrates with the following applications:

Salesforce Sales Cloud

Q. What level of support does Dot Compliance offer?

Dot Compliance offers the following support options:

Phone Support, Online Support