What does our Digitial Auditor Application(Patent Pending) offer?
The Digital Auditor Application is a specialized software solution that facilitates the monitoring, evaluation, and enforcement of regulatory requirements within systems and processes. This application is designed to systematically review records, transactions, and activities to ensure they align with industry-specific regulations, government regulations, and internal policies. Through automated data analysis and rule-based assessments, the application identifies potential compliance breaches, discrepancies, or deviations from established guidelines. It generates comprehensive reports and alerts, enabling organizations to proactively address compliance issues, mitigate risks, and maintain adherence to relevant regulations, thereby fostering a culture of accountability and integrity;
- Always have an up-to-date checklist of the regulations
- Able to record notes, findings, etc. digitally and then transfer the information to a report with the press of a button
- Reducing the time from the start of the Audit process to the closing meeting, and thereby reducing cost
Clients
Projects
Hours Of Support
Hard Workers
Regulations and Standards Covered
The following is a list of Regulations currently covered by the Digital Auditor App, which includes but is not limited to;
FDA 21 CFR Part 820
21 CFR Part 820 provides requirements for a company to set policies, operating procedures, guidelines and objectives that will ensure product safety and effectiveness.
ISO 13485:2016
ISO 13485:2016 specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
EU MDR
The European Medical Device Regulation (MDR) is a set of regulations that governs the production and distribution of medical devices in Europe. Compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.
IEC 62304
IEC 62304 is a functional safety standard that covers safe design and maintenance of software. It provides processes, activities, and tasks to ensure safety.
And many more..........
As Regulations and Standards are being updated, and new ones are being developed we will continue to offer the most up-to-date information to you, our new Partner.
Features of our Digital Auditor offering
Below is a list of a few of the features which are provided by our Digital Auditor app
Checklists of the most up-to-date Regulations and Standards
The Regulations and Standards within the Digital Auditor App will always be the most current as required by the Regulatory Agencies
Provides additional Insight
Digital Auditor will provide additional insights into the regulations and standards based on any additional available material(s), such as Guidance Documents, White Papers, Best Practices, etc.
Ease of Use
The main goal of the Digital Auditor App is to provide you with an “Intuitive Auditing Experience” which makes auditing easy; not only for seasoned auditors, new auditors, but also for employees with no auditing experience.
Safe & Secure
Digital Auditor App is safe and secure to use, utilizing the most up-to-date security protocols
Frequently Asked Questions
See below for answers to the most frequently asked questions, and if the answer you are looking for is not provided please select "Contact" above and we will respond as soon as possible.
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Is this Application Validated?
The Application itself is validated and if you are ever audited please contact us for supporting documentation.
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What if I don't see a Regulation/Requirement/Standard which is applicable to our business?
We are constantly adding new Regulations/Requirements all the time. If there is a Regulation/Requirement you would like for us to add, please send us a quick note with the document name and number and we will work to ensure that it becomes available.
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We have completed the Audit process and now we are in need of Consulting/Remediation help?
Our staff has over 30 years of combined experience in assisting companies by providing compliance consulting and remediation expertise. Please reach out to us by clicking "Contact" at the top of the page to discuss your needs.
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How is this Audit Process different than the process that I have always used?
The best way for me to explain it is that the old audit process is like using a paper map to get around, which still works. However as new technologies became available, easier and more efficient ways of getting directions were created like Google Maps, Waze, etc.. Our process is the Google Maps/Waze/etc of auditing: an easier, intuitive, and more efficient way of performing an Audit.
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Our company has multiple divisions with multiple auditors, do you have special packages for companies like ours?
We do, please reach out to us by clicking "Contact" at the top of the page and we can discuss a package that works best for your business.
Contact Us Now!
Let us help you automate many manual tasks related to your auditing procedures.
Email Us
info@audittech.net