Touchstone Technologies is a Regulatory Auditing, Consulting, and Training firm that specializes in Healthcare Pharma, Biotech, Food, and Medical Devices industries.


Our goal is to help your company stay compliant with FDA, CLIA, CAP and other domestic and international Regulatory Agencies requirements.

Solutions

Auditing

Consulting

Consulting

A female doctor with blond hair and the blue glove is holding a read capsule

Auditing provides management with information about how effectively the company controls the quality of its processes and products. Our Auditors provide information on gaps between a company’s processes vs. regulations such as USFDA cGMP, Data Integrity, CLIA, and CAP. Regulations and other quality standards like ICH Q10.  Our Auditors can then make recommendations on solutions to potential issues, support the company with the remediation of those issues, and be available to support a company during an inspection.

Consulting

Consulting

Consulting

Two FDA consultants. A young man with brown hair  and in a white shirt and a blond girl in a pink shirt is seating by the table and discussing FDA project

Our Consultants ensure that companies follow applicable government regulations such as USFDA, EMEA, CLIA, and CAP regulations. Their tasks include ensuring that company employees are familiar with applicable regulations. They may also consult with staff on different projects to ensure that production methods or design plans will comply with regulations.

Our consultants will often take a leadership role in developing policies that are designed to maintain regulatory compliance. They may establish procedural guidelines. Their duties also involve gathering reports and paperwork that is required to demonstrate that their organization follows the applicable regulations and may also submit materials to government agencies as required.

Training

Turnkey Solutions

Turnkey Solutions

The FDA consultant who is a man in a blue shirt and black pants is teaching a big group of people.

We offer on-site and web-based training services on the most pressing issues that the industry is currently facing. The online training is more generalized, keeping in mind the audience who attend from different companies. If a client is looking for something more customized, we do offer customized online training and customized on-site training. 

Turnkey Solutions

Turnkey Solutions

Turnkey Solutions

Colorful papers on the table and hands of people who are discussing a FDA project

Touchstone will undertake a complete end to end project delivery to meet client requirements. Our personnel will interview the client and then undertake the responsibility for the essential design of the product/project. Touchstone would only request client participation where the client either prefers to participate or where the client has essential data knowledge that cannot be supplied by Touchstone; this reducing client time required for a project.  Touchstone may deliver such a project/product, with Touchstone personnel, or by working with one or more of our excellent partners, that bring in-depth expertise to each specific situation. Further, at the client’s agreement, Touchstone may outsource the work to non-US personnel, to reduce product/project costs.

AREAS OF EXPERTISE

21 CFR Part 11

Clinical Data Management

Artificial Intelligence

Artificial Intelligence

Clinical Data Management

Artificial Intelligence

Clinical Data Management

Clinical Data Management

Clinical Data Management

Cloud Compliance

Cybersecurity [ISO/IEC 27001][ISO/IEC 27002]

Clinical Data Management

Cloud Implementation

Cybersecurity [ISO/IEC 27001][ISO/IEC 27002]

Cybersecurity [ISO/IEC 27001][ISO/IEC 27002]

Cybersecurity [ISO/IEC 27001][ISO/IEC 27002]

Cybersecurity [ISO/IEC 27001][ISO/IEC 27002]

Cybersecurity [ISO/IEC 27001][ISO/IEC 27002]

Data Integrity

Equioment Validation

Data Migration

Data Migration

Equioment Validation

Data Migration

Equioment Validation

Equioment Validation

Equipment Qualification

Equipment Qualification

General Data Protection Regulation

Equipment Qualification

Etmf Data Migration

General Data Protection Regulation

General Data Protection Regulation

General Data Protection Regulation

General Data Protection Regulation

General Data Protection Regulation

Good Clinical Practices (GCP)

Good Manufacturing Practices (GMP)

Good Laboratory Practices (GLP)

Good Laboratory Practices (GLP)

Good Manufacturing Practices (GMP)

Good Laboratory Practices (GLP)

Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMP)

Hardware Qualification

Medical Devices [ISO 13485-2016 Quality Management System]

Good Manufacturing Practices (GMP)

Hardware Validation

Medical Devices [ISO 13485-2016 Quality Management System]

Medical Devices [ISO 13485-2016 Quality Management System]

Medical Devices [ISO 13485-2016 Quality Management System]

Medical Devices [ISO 13485-2016 Quality Management System]

Medical Devices [ISO 13485-2016 Quality Management System]

Online Training

On-site Training - Customized

Online Training - Customized

Online Training - Customized

On-site Training - Customized

Online Training - Customized

On-site Training - Customized

On-site Training - Customized

On-site Training - Customized

Remediation

Software Qualification

On-site Training - Customized

Software Qualification

Software Qualification

Software Qualification

Software Validation

Software Qualification

Software Qualification

Standard Operation Procedures (SOP)

Download Our training catalog

Files coming soon.

Our Partners

Logo of GlobalCompliancePanel. Regulatory Training compliance company. Light blue and dark blue ball
The FDA training company's logo. Big FDA letters and smaller letters of Educator.
Logo of our training company which is an FDA training platform. Half of a blue cloud
Logo of regulatory FDA training company.
Logo of the company named Compliance Trainings. The regulatory training company
Big letter C on a blue background. A logo of a Compliance4all firm. FDA regulatory training company
Loog of Pioneer Educator. Big letter P and yellow square