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Isolocity is the complete life science qms for ISO 13485, MDSAP & GMP

Isolocity life science qms offers in-house life science compliance standard experts, full-support & training with certification roadmap, scalable software with customizable UI, stress-free audits & certification, secure cloud infrastructure, and smart system-wide automations for medical device, pharmaceuticals, nutraceuticals, and natural health products

Isolocity life science qms is compliant with FDA 21 CFR Part 11 and Annex 11

Isolocity Life Science QMS Features






Built for the
Life ScienceIndustry

  • Pharmaceutical: House documents in Isolocity life science qms; set up approval, view, and edit permissions. Documents are revision-controlled, and you can view past document revisions.
  • Natural Health: Create an out-of-specification report for a product by lot/batch; record investigation actions and results
    • Escalate to CAPA, non-conformance, deviation, and change control
    • Identify whether a recall was required as a result
  • Lab: Create a maintenance schedule for your equipment by adding the template to the equipment and assigning a frequency. Owners will be notified when maintenance is due. All activities are documented in Isolocity.
  • Medical Device: Ensure supplier performance is acceptable and meets requirements. Maintain supplier certificates and other documents in the supplier’s profile in Isolocity. Send suppliers a request to upload their updated certificates and documents directly into their Isolocity profile.

Life Science Companies that

have trusted us

We provide support based on the
needs of the Life Science Industry

Privacy is a big concern for Life Science companies
Our Solution: We own every line of code in our software, giving us better control. Also, we work with AWS which is known for one of the best security measures. Isolocity is also SOC 2 Type II compliant.

Affordability quotient of Isolocity
Our solution: We are known for being one of the most affordable solutions. We offer free SOPs, Training, and Implementation hours. All basic users are also free. Our solution can reduce your overhead by 70%. We don’t charge any activation fees.

Data lies on all different platforms
We know Life Science companies use a lot of software and platforms and decentralized reports are a challenge. To make your life easier, Isolocity’s API allows you to bring all data to one place. For example, if you conduct technological inspections with your IoT-enabled inspection software, you can integrate that with Isolocity and have your inspection report generated automatically in Isolocity.

Industries we serve


Choose Us

Isolocity life science qms is compliant with Life Science industry regulations and standards – ISO 13485, MDSAP, FDA 21 CFR Part 11 & Annex 11.
Isolocity life science qms has ready-made free SOPs which will help you obtain FDA approvals faster.
We have all the modules of a standard EQMS but at a very affordable price. We do not charge any activation fees.
We are a device-agnostic solution. Our software is compatible with tablets & mobile devices.
The Life Science industry is rapidly changing, thus we are also constantly releasing updates for our life science qms.
We offer a variety of analytics and downloadable reports which can be helpful for trend analysis and reporting requirements.
We have a huge amount of extra resources to help you be successful – watch and learn at your own pace in our learning center & knowledge base.


My experience with Isolocity has been fantastic so far. The setup was painless, and their support team is terrific! Quick to respond and resolve any issues in a timely and professional manner!

John S. from High North.Industry: Laboratory

It has all the features I need for a company of our size and the price is fair.QMS is friendly user.Very good customer service, very fast turnover .

Sara M. from Believe Supplements.Industry: Natural Health Product

It is a software very easy to use, additionally its interface is very simple, comprehensive and intuitive, covers many features and areas of utmost importance to meet the quality standards imposed by ISO standards, so it facilitates certification, also occupies the field of production and / or maintenance by generating orders or commands needed to calibrate or verify the equipment, keeps online all documents necessary for AS / ISO and tracks all KPI, such as quality and delivery performance.

Carlos B. from SB Tool & Machine Co.Industry: Aerospace

Isolocity has been a turn key solution to implementing the ISO9001:2015 standard. Chris and the Isolocity team have made for a fast, easy and fun transition into implementing data control. With the easy to use software and excellent customer service offered, I would recommend this solution to any business concerned with Quality Control.

Danielle Vine from Dvine Laboratories.Industry: Laboratory

The team at Isolocity are very supportive during the learning process and really spend the time to be sure that we transitioned effectively. The software is intuitive, well designed and captures everything we need without a huge learning curve and a long startup process.

Jeff N. from Ambix Manufacturing.Industry: Manufacturing

Efficient, user friendly, keeps everything in one place, over the internet which means it's accessible from anywhere around the world. Keeps your drawings, parts characteristics, notes. Generates orders (which we use as work orders). Alerts you when it's time to calibrate or check equipment, keeps all necessary documents for AS/ISO online plus keeping track of all KPI's such as quality and delivery performances.

Arsany B. from SB Tool & Machine.Industry: Aerospace

Good service, easy-to-use, and a great software to get your business organized and manageable.

Jacob Luke J. from TJP Labs.Industry: Biotechnology

We have been using Isolocity since 2018 and have nothing but good things to say about Chris and the Isolocity team. Whenever we have had a support request, the Isolocity team have been exceptionally responsive and quick to resolve any issues. In addition, the Isolocity software has helped us iteratively maintain our ISO 9001:2015 certified quality management system and pass external audits with flying colours.

Michael Amadi from Nimble Learn.Industry: Service

Isolocity keeps us honest when maintaining our internal SOPs. Not only with the internal training tutorial to use the tutorial, but followups from their customer success representatives weekly to ensure we have the support we need. CAPA, alerting, version control of SOPs and release forms are all easily done in Isolocity.

Daniel Wanis-Ruiz from Elevated SignalsIndustry : Service

The software offers an abundance of features at an incredibly affordable price. It's exceptionally user-friendly and intuitive to navigate.

Greg J. from Far Chemicals.Industry: Chemicals

Isolocity has really come to bat for us when it comes to the support of their products. Their level of communication and flexibility has helped reduce countless headaches. This is a company that truly stands behind their product and has provided an excellent level of service.

Brandon Basham from Marimed.Industry: Cannabis

User friendly in production -Traceability is effective -Training management is automated -SOP Version control/change control is easy to use -Complaints, change control, non-conformance, OOS and deviations are already built in

Sebastien R from Newpharma Gnik.Industry: Food production

We LOVE Isolocity for Document Control, Equipment Maintenence and Training.

Phil H. from Pond Naturals.Industry: Biotechnology

I absolutely adore this software. I honestly can't think of any downsides to this program.

Antônio A. from BZAM.Industry: Cannabis

We are proud customers of Isolocity. It’s an excellent tool, it helps us save a lot of paper. With Isolocity we are able to track everything digitally. It’s been an excellent relationship with Isolocity, they provide great customer service. If we face any issue or any question, they provide training on how to use Isolocity for our employees. Isolocity has been amazing for us, happy to work with them.

Rick Moriarity from High North.Industry: Laboratory

The customer service at Isolocity is superb. The agents are easily reached easy to talk to and respond in reasonable time. This way your work flow is not delayed. They also check in on you if they have not heard from you in a while to ensure that everything is going well. They facilitate training and make suggestions on how we can better utilize the services of Isolocity.

Odette C. from Pure Jamaican.Industry: Pharmaceuticals

Ease of accessibility and fillable templates helped to eradicate paper forms.User friendly and works on any device.Task assignments, Implementation Plans and Notifications recorded on reports.

Faith M. from Bold GrowthIndustry: Natural Health Product

Isolocity has great expertise in quality management. Their consulting service and innovative Isolocity software were really helpful in our ISO certificate application process. I would highly recommend Isolocity and Chris for other small-medium enterprise who are seeking consulting and software solutions for quality management.

Tony.X. Cao from AUG SignalsIndustry: Manufacturing