About Dot Compliance

Dot Compliance offers the industry's first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance Suite includes an extensive set of off-the-shelf ready eQMS and compliance pre-configured best practice processes, enabling customers to deploy quickly and cost effectively.
Dot Compliance ready to use solutions include full project validation services and product validation packages. Our solutions are trusted by many life sciences companies worldwide and by thousands of users. We are fully compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971 and 27001.

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.

Ready to use solutions include:

▶ Document Management – Capture, track and store all your documents in one place. Our capabilities include Part 11 Compliant e-signatures, approval workflow, revisions control and more. It easily integrates with other QMS business processes providing a closed loop system.

▶ Training Management - Manage end-to-end employee training from record management, course distribution and completion, and escalation.

▶ Complaint Management – Ready to use compliant handling ensures regulatory compliance, enhances product development, mitigates risk, and finds opportunities for growth and innovation by meeting specific customer requirements.

▶ Change Management – Change Control through QMS Xpress offers a standardized process for workflow flexibility, allowing a life sciences manufacturer to manage all types of changes from one centralized platform.

▶ CAPA - Dot Compliance automates CAPA processes to safeguard your organization from regulatory risk, and include integration with other core quality processes such as audit, training, document management, change control, etc.

▶ Risk Management – A proactive and risk based approach to quality management systems minimizes the chances for undesired effects as well as continual improvement by predicting potential problems. It also lowers the risk of manufacturing problems that may result in shorter and fewer FDA and EMA inspections.

▶ Deviations/Non-conformance Management – Managing deviations and other quality events is required by GMP. Dot Compliance cloud-based, fully validated QMS provides organizations with the ability to manage deviations so they are identified and recorded. This includes Incidents that could affect the quality or the reliability of records or tests to be investigated and resolved.

▶ Supplier Quality Management - Manage, track, and collaborate with suppliers, contract manufacturers, and distribution chain partners across the entire supply chain. Consolidate quality management silos of suppliers, contracted manufacturing organizations (CMO), internal production divisions, and distribution supply chain into one connected quality system.


Key benefits of Dot Compliance

Forget about lengthy & costly QMS implementations.

Dot Compliance provides data migration expertise to overcome the challenges for a quick and cost-effective QMS implementation.

Processes included:
▶ Document Management
▶ Training Management
▶ Quality Event Management
▶ CAPA Management
▶ Change Management
▶ Complaint Management
▶ Audit Management
▶ Supplier Quality Management
▶ Risk Management
▶ Design Control
▶ Deviations/Non-conformances

✔ Seamless Install - Deploy quickly and get up and running within a matter of days with minimal set up required. Leveraging advanced data migration capabilities, Dot Compliance offers the industry's fastest QMS deployment.

✔ Cost Effective - Comprehensive ready to use QMS solutions 20-30% less expensive than other industry solutions. Eliminate the need for expensive consultants & services. Pre-configured and pre-validated with sample SOPs and KPIs.

✔ One-Stop-Shop - For life science manufacturers of all sizes, we offer a comprehensive set of ready-to-use solutions: QMS, Document Management, Supplier Quality, Audits, EBR, PLM, LIMS, RA, CTMS, Maintenance, and more.


Images

Dot Compliance Software - Dot Compliance eQMS
Dot Compliance Software - Dottie AI, your eQMS AI Assistant
Dot Compliance Software - Improve your quality control and compliance with the industry's top solution for quality management. Save time and money while delivering products to market quickly and efficiently.
Dot Compliance Software - All in One solution
Dot Compliance Software - Adherence and Commitment
View 6 more
Dot Compliance video
Dot Compliance Software - Dot Compliance eQMS
Dot Compliance Software - Dottie AI, your eQMS AI Assistant
Dot Compliance Software - Improve your quality control and compliance with the industry's top solution for quality management. Save time and money while delivering products to market quickly and efficiently.
Dot Compliance Software - All in One solution
Dot Compliance Software - Adherence and Commitment

Not sure about Dot Compliance? Compare with a popular alternative

Dot Compliance

4.5 (26)
VS.
Most reviewed

Starting Price

No pricing found
US$7.75
month

Pricing Options

Free version
Free trial
Free version
Free trial

Features

98
160

Integrations

6
20

Ease of Use

4.1 (26)
4.0 (13,931)

Value for Money

4.0 (26)
4.3 (13,931)

Customer Service

4.3 (26)
4.2 (13,931)
Green rating bars show the winning product based on the average rating and number of reviews.

Alternatives

CQRM XD Quality Management

0
#1 Alternative to Dot Compliance
Labwise is a unified laboratory management system that unifies LIMS, ELN, QMS, DMS, data management, and analytics....

Jira

4.4
#2 Alternative to Dot Compliance
JIRA is the tracker for teams planning & building great products. Millions choose JIRA to capture & organize issues,...

Cority

4.3
#3 Alternative to Dot Compliance
Cority offers enterprise level companies a web-based environment, health, safety and quality management software...

QCBD

4.6
#4 Alternative to Dot Compliance
QCBD is a Windows-based QMS (quality management system) for small to mid-size manufacturing companies which supports a...

Reviews

Overall rating

4.5 /5
(26)
Value for Money
4.0/5
Features
4.1/5
Ease of Use
4.1/5
Customer Support Software
4.3/5

Already have Dot Compliance?

Software buyers need your help! Product reviews help the rest of us make great decisions.

Showing 5 reviews of 26
Jennifer
Overall rating
  • Industry: Pharmaceuticals
  • Company size: 201–500 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Most Comprehensive eQMS on the Market!

Reviewed on 2022-11-01

Dot Compliance QMS is excellent at tracking training, and creating detailed reports regarding open...

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.

Pros

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.

Cons

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.

Reasons for Switching to 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.

Response from Dot Compliance

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

Terry
Overall rating
  • Industry: Pharmaceuticals
  • Company size: 11–50 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

The Industry Gold Standard

Reviewed on 2023-09-18

Gone are the days of chasing down signatures or being tied to the office. Dot Compliance has...

Gone are the days of chasing down signatures or being tied to the office. Dot Compliance has liberated us from the constraints of paper and Excel-based Quality Management systems. The difference is like night and day, and our team can attest to the immense relief it brings. Now, we can focus more on our core tasks, confident that our compliance needs are being expertly managed. We conducted extensive research on eQMS systems before settling on Dot Compliance, and I can confidently say that it stands head and shoulders above the rest. It's more than just a software solution; it's a partner in our business success. If you're in the market for an eQMS system that truly delivers on its promises, look no further than Dot Compliance. It's the gold standard, and it has our highest recommendation.

Pros

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.

Cons

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 Considered

Odoo and Qualio

Reasons for Switching to Dot Compliance

Cost, ease of installation. With Odoo, we were actually developing the system from scratch, however, Dot made total sense for us.

Response from Dot Compliance

Thank you for taking the time to review our product, we really appreciate your comments!

We are glad to hear you are happy with Dot Compliance eQMS.

The Dot team is constantly working to improve the product and user experience.

Kind regards,
Adam Rona, VP of Product

Corinne
Overall rating
  • Industry: Biotechnology
  • Company size: 11–50 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 5.0 /10

Promising sometimes disappointing

Reviewed on 2020-03-09

frustrating

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

Cody
Overall rating
  • Industry: Health, Wellness & Fitness
  • Company size: 51–200 Employees
  • Used Monthly for 6-12 months
  • Review Source

Overall rating

  • Ease of Use
  • Likelihood to recommend 8.0 /10

A thorough platform to manage documentation

Reviewed on 2023-12-09

This is a thorough platform that lets me do everything I need to. The activity trail is critical...

This is a thorough platform that lets me do everything I need to. The activity trail is critical and is very clearly documented.

Pros

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.

Cons

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.

Response from Dot Compliance

Thank you for the Feedback and comments.
We are glad to hear you are happy with your Dot Compliance system, We are planning additional enhancements and capabilities in the coming versions for the electronic forms.

Kind regards,
Adam Rona
VP of Product

Ferhat
Overall rating
  • Industry: Machinery
  • Company size: 11–50 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Flawless Compliance with Dot Compliance

Reviewed on 2022-12-07

I have had a great experience with Dot Compliance. The software has been invaluable in keeping me...

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

Pros

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.

Cons

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.

Showing 5 reviews of 26 Read all reviews

Dot Compliance FAQs

Below are some frequently asked questions for Dot Compliance.

Dot Compliance offers the following pricing plans:

  • Starting from:
  • Pricing model: Subscription
  • Free Trial: Available

Contact Dot Compliance for pricing information.

Dot Compliance has the following typical customers:

2–10, 11–50, 51–200, 201–500, 501–1,000, 1,001–5,000

Dot Compliance supports the following languages:

English, European Portuguese, French, German, Hebrew, Portuguese, Russian, Spanish

Dot Compliance supports the following devices:

Android (Mobile), iPhone (Mobile), iPad (Mobile)

Dot Compliance integrates with the following applications:

Amazon S3, Aspose.Total, Google Sites, NetSuite, Salesforce Sales Cloud, Zendesk Suite

Dot Compliance offers the following support options:

Email/Help Desk, FAQs/Forum, Knowledge Base Software, Phone Support, Chat

Related categories

See all software categories found for Dot Compliance.