21 CFR Part 11 Compliance with the TRINITY V3 Antibiotic Zone Reader

TRINITY V3 is only system that strictly complies with 21 CFR Part 11 electronic signature requirements from reading test plates to reporting test results including:

·    Three level access control with user ID and password (Read Only, Standard User, Administrator)
·    Password expiration settings
·    Minimum password and user ID length settings
·    Secure, encrypted database
·    User access log and data audit trails
·    All changes to users, configuration, and system settings are logged
·    All test results are marked with user ID, date and time

TRINITY V3 settings are customizable to exactly meet your laboratory compliance needs. Contact Giles Scientific for detailed 21 CFR Part 11 Compliance specifications and questions.

Customer Testimonials for the TRINITY V3 Antibiotic Zone Reader


"Significant Labor Savings and Simple Validation with TRINITY V3"

"TRINITY V3 has been an excellent addition to our laboratory. The IQ, OQ, PQ qualification was easily completed within a few weeks. Since implementation, the efficiency in our laboratory has increased significantly in comparison to our old system. We no longer lose a whole day to reading plate assays.

One of the reasons the qualification was smooth was because of the excellent customer service. Any small bump along the way was answered immediately and thoroughly by a team of efficient and dedicated individuals. The team was always available to assist our individual needs."

Laura Olson
QC Manager
Pennfield Animal Health, Omaha, NE USA
TRINITY V3 customer since 2011



"Great Customer Service and Support from Giles Scientific!"

"TRINITY V3 is a well-built and easy to use device that never let us down. It also enables us to produce faster results on our USP antibiotic bioassay in animal feeds. Since we have had TRINITY V3 we have asked for minor adjustments specific to our needs. These demands were treated rapidly and efficiently and the customer service is great!"

Vanessa Marsan
Nutreco Canada
St-Hyacinthe, Quebec, Canada
TRINITY V3 customer since 2005



"Excellent products and technical customer support"

"It has been a pleasure working with Giles Scientific and their incredible team. They offer some of the best customer support I have ever experienced with a vendor. They are very quick to reply to customer queries and are also very helpful. The quality of their peni dispenser and peni cylinders is excellent. The peni dispenser works like magic in setting up antibiotic assays. The analysts running the assay are very pleased using the peni dispenser.

We currently purchased the TRINITY V3 and it has made the antibiotic assay work a lot faster. It was very easy to run the qualification on the equipment and the technical support was very prompt and helpful with answering all our questions. Purchasing this piece of equipment was a great investment for the lab. It has saved the analysts a tremendous amount of time and has increased productivity and efficiency "

Pallavi Chhabra
Manager, Microbiology Laboratory
Specialized Technology Resources, Canton, MA
Peni Cylinder Dispenser customer since 2009
TRINITY V3 customer since 2010



"TRINITY V3: User friendly system with consistent results"

"TRINITY V3 instantly reads and calculates the zones of inhibition for our USP and MYCO antibiotic potency tests. It has significantly reduced our labor time for this assay. The software is very user friendly system and provides consistent results for our microbiology lab. I have worked with Giles Scientific for several years and their service and support is excellent."

Carlos Flores
Pharmaceutical Manufacturer
Puerto Rico
TRINITY V3 customer since 2005



"TRINITY V3: A Reliable Instrument for our USP Antibiotic Potency Assays"

"The TRINITY V3 is flexible and very reliable for our USP antibiotic potency assays. The optics produce high quality images and the software interface is easy to use and navigate. It allows for visual verification of the inhibition zones on screen. TRINITY V3 is also fully compliant with 21 CFR Part 11 requirements."

Daniel Eshete, Ph.D.
APP Pharmaceuticals
Grand Island, NY, USA
TRINITY V3 customer since 2007


"Easy setup and validation of TRINITY V3 Zone Reader"

"It has been pleasure working with the Giles Scientific sales and service team as we implemented the TRINITY V3 zone reading system for our USP antibiotic potency assays.  Their qualification documentation was very simple and straightforward, and the support we received has been great. The system was completely implemented in just a few weeks and we’ve had nothing but praise from the analysts in the lab.  The TRINITY V3 system has been very reliable and much easier to use than our old system.  We’re looking forward to many years of working with Giles Scientific."

Lab Manager
Michigan-Based Pharmaceutical Manufacturer
TRINITY V3 customer since 2009

Training and Support for the TRINITY V3 Antibiotic Zone Reader

Annual Service Contract Includes:

1. Live customer support by telephone and email (7 days/week)
2. Complete hardware warranty
3. All software updates with new TRINITY V3 product features
4. System installation and setup (via telephone and email)
5. IQ, OQ, PQ validation support (via telephone and email)
6. Access to training videos available at the Online Customer Support Center

Installation

Most customers set up TRINITY V3 themselves or with their own computer (IT) representative in under one hour. Easy-to-follow instructions are provided in the product manual and on-screen Help. System installation videos are also available online at the Customer Support Center. Giles Scientific is available by email or telephone to assist with the installation and training process until the customer is completely satisfied. 

Training Includes:

1. Extensive training videos available online at the Customer Support Center
2. Product Manual (hard copy and electronic)
3. Step-by-step Help instructions on-screen
4. Training with TRINITY V3 product specialist via teleconference

Maintenance

TRINITY V3 requires no routine maintenance; it contains no motors or moving parts, only solid-state digital electronics. Less than 3% of our image analysis systems require service in 5 years. TRINITY V3 is highly reliable and rarely the source of a problem. Giles Scientific live telephone technical support is available 7 days a week.

Validation and Regulation with the TRINITY V3 Antibiotic Zone Reader

Giles Scientific includes Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) validation documents with each TRINITY V3 purchase. These documents comply with 21 CFR Part 11 (Code of Federal Registry), Association of Analytical Communities (AOAC), Good Laboratory Practice (GLP) standards, and US-FDA Bacteriological Analytical Manual (BAM). Validation protocols may be customized to meet each laboratory's unique certification requirements.

About Giles Scientific Inc.


Giles Scientific was incorporated in New York City in 1984 after US-FDA clearance to market the BIOMIC System to clinical microbiology laboratories. The company is currently located in Santa Barbara, California. In 1985, the TRINITY System was introduced for quality assurance and potency testing of newly manufactured lots of antibiotics. Both products were designed to facilitate and speed, reading, analysis, and reporting of agar diffusion antimicrobial assays. In 2005, the V3 model was introduced. The BIOMIC V3 and TRINITY V3 systems are designed to be highly reliable, flexible, and to eliminate maintenance by utilizing solid state electronics with no moving parts.

After 25+ years of research, Giles Scientific continues to focus on enhancing the capabilities of our systems with the latest color digital imaging technology. Our products utilize consumable test materials manufactured by other companies, providing an open system to our customers and eliminating the need to use costly proprietary materials.

Numerous international publications document the accuracy and consistency of BIOMIC V3 and TRINITY V3. 60+ customer testimonials attest to the quality of our products and our commitment to service and support. Annual software updates and online training are available from our website. Live customer support and service is available 7 days per week. Giles Scientific functions as a cohesive team to serve our customers in microbiology laboratories worldwide. Our products enhance the knowledge, test result quality, and workflow productivity in hospitals, public health laboratories, research facilities, and industrial microbiology laboratories in 63 countries.