RXinsider: USP <797> Compliance providers on the RX Showcase

Isensix

Pharmacy Category:
Quality Assurance, Automation, ROI, JCAHO, USP <797>, avoidance

(Old Manual Way)

(Eliminate Manual Paper Methods)

(View Real-time Status On All Equipment)

(Continuous monitoring and alerts)

WIRELESS TEMPERATURE MONITORING

USP <797> and JCAHO Compliant
Be Prepared For Unannounced Inspections
Isensix is the Vendor of Choice for Top 200 Pharmacies and Medical Centers Nationwide

Currently, staff members are required to manually collect data from refrigerators, freezers, and other types of storage units used to store medication, and chemicals, and either record them on daily log sheets, or collect expired rotary charts. Not only is this practice fraught with numerous inherent problems by relying on human memory and staff already working at their upper limitations, but the ramifications of inaccurate reporting, and the potential negligence of a failing unit, can be extremely costly.

But that was then, this is now, and the future is today! Because by utilizing our patent-pending Advanced Remote Monitoring System (ARMS™) technology, Isensix provides customers with a complete end-to-end enterprise solution. We can monitor a single room or an entire campus. Our 24/7, wireless, real-time solutions eliminate the need for any manual temperature monitoring processes—all without costly changes to facility infrastructure.

Isensix technology provides the following:

Peace-of-mind with the most reliable, highest quality system available
Immediate positive return on investment (ROI) from labor savings and avoidance of loss
Continuous monitoring and alerts for temperature, humidity, air flow, door access & more
User-friendly web-browser
Central data collection record keeping on a secured server with Intranet and Internet remote access
Real-time visual, audio, e-mail, paging, and voice notifications to staff, bio-medical engineering, and staff workstations
Complete training, validation, calibration, documentation to meet JCAHO and USP <797> requirements
Fully compliant with FDA 21CFR Section 11 Electronic Signature
Automated compliance reporting, corrective action logs, and back-up

For more information about our products, please use the links below to contact us or visit our website.

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Coldchain Technology Services

Pharmacy Category:
Environmental Monitoring, Temperature Monitoring, 21 CFR Part 11

Excel Based Reporting
Software

Calibrated Ethernet
Connected Sensors

Wired and hospital approved
wireless sensors available for clean room, negitive/positive pressure rooms, and others.

SQL Based Graphs
and Trending

Configurable Alarm Limits

3M TL25 Datalogger

Benefits of Using Coldchain Technology Services

Reduce cost of temperature monitoring and recording.
Eliminate product loss due to compromised storage temperature.
Reduce medical liability from accidentally vaccinating patients with ineffective vaccine or providing medications that are ineffective due to a compromised storage environment.
Helps achieve compliance with USP 797 temperature guidelines, JCAHO MM.2.20 & EC.6.10 standards, CDC standards, and FDA 21 CFR (Part 11, Part 210, Part 211) guidelines.
Document process improvement efforts as part of a QA / QC program.
Provide a comprehensive roadmap to satisfy the audit portion of critical contained environment areas.

Plug-n-Play Monitoring System

Simple desktop software
Excel based reporting software
Easy plug and play installation
Alarm notifications
Calibrated thermocouple probe
Ethernet connected devices

The Plug-n-Play system provides oversight of climate controlled environment/equipment for less cost than traditional monitoring systems. The devices are shipped with informational software that walks you through the installation process. All installation hardware, a calibration certificate from Coldchain Technology Services, a user's guide, and self assessment forms are included.

Custom Monitoring System

Dedicated PC user interface and system
Integrated SQL reporting
Wireless and direct wired installation options
Single site and enterprise solutions available
Visual display of your facility
Validations and other services can be included

The Custom Monitoring System would encompass a 21 CFR part 11 compliant environmental monitoring system as well as an enterprise wide alarm and control package. These systems typically include data storage, system management, and alarm notification via phone or pager. Additional options that could be offered are building layouts, validation, inventory management, web based monitoring and process control. Each of the features are offered to meet your individual requirements.

Some of our sensor options include:

Temperature
Humidity
Light
Pressure
Video
Doors (open closed)

Environmental Assessment

Identify deficiencies and provides recommendations
Detailed assessment of equipment over 14 days
Summary of hourly average temperature of the unit
Min, max, and average temperatures
Dates and times of excursions, time at max/min
Recommendations on how to correct the deficiencies

Coldchain Technology Services recognizes that most facilities/businesses operate on strict budgets while striving to meet industry standards and regulations. CTS offers assessment services to help you decide whether you need to invest in new equipment and whether it's time to institute an electronic monitoring capability. Depending on your needs, we can assess a single refrigerated unit or provide extensive on-site evaluations to include protocols, equipment, SOPs, process improvements, etc.

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Pharmaconomics, Inc.

Pharmacy Category:
UPS <797> Compliance Software, 797 Gap Analysis and Plan

Care Fusion

Pharmaconomics is a leading developer of niche pharmaceutical software dedicated to supporting the practice of pharmacy. Our products feature advanced technology solutions that help simplify many of the complex requirements faced by pharmacists. We embrace a philosophical approach that entails supplementing those solutions with products and services to create complete "TURN-KEY" programs for total problem resolution or operational compliance.

Although you may pick and choose only the components of the program that meet your immediate needs, 797-COMPLETE is the only true "TURN-KEY" solution to meet all the requirements of USP.

The program begins with onsite analysis of operator techniques as well as the policies and procedures currently being used. After evaluation of products compounded, volumes and available space, a formal report is provided that can serve as a "GAP" analysis, but also includes immediate action steps and several custom environment design options. Once you have decided on your environment, a detailed Quality Assurance Plan is created specific for your hospital, including all the written policies and procedures customized for your institution.

Modular Cleanrooms are constructed in a matter of days, as you follow the plan that was developed for compounding during the construction period, which may or may not include bringing a Pharmaconomics mobile cleanroom to your site or providing temporary onsite compounding hoods.

Both didactic and practical onsite training is provided as operators are certified using the optional Pharmaconomics' risk-level media-fill kits. The patent-pending OSIRIS 797 Software makes ongoing compliance easy with master-record controls, one touch documentation and daily 797 activity calendars.

For more information about Pharmaconomics, Inc. solutions or to contact us, use the link provided below.

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Analytical Research Laboratories (ARL)

Pharmacy Category:
Pharmacy Compound Analyses • Compounding Quality Control • Pharmaceutical Potency Analysis • Microbial Contamination Testing Services • Laboratory Services • Forensic Toxicology

Analytical Research Laboratories (ARL), a division of ARL Biopharma, has been serving the pharmaceutical and health-related industries since 1994. With over 50 years of combined experience in the industry, ARL can meet and exceed your analytical needs. We offer a full range of professional laboratory services, both analytical and microbiological, as well as consulting services, research and development and forensic legal support. ARL’s professional staff can respond to even the most unusual requests. We use state-of-the-art instrumentation, and provide rapid turnaround time and personal service. Contact us for additional information or a detailed quote.

Laboratory Services
Analytical Research Laboratories (ARL) offers complete analytical services utilizing state-of-the-art instrumentation, including Gas Chromatography (GC), Liquid Chromatography (LC) and Mass Spectrometry (MS). ARL also provides compendial testing according to USP/NF, BP, EP, JP, and ACS monographs. In addition to our analytical testing capabilities ARL has a microbiology department for sterility, fungal, endotoxin testing, cell culture tests, bacterial and fungal identification, and preservative effectiveness testing.

ARL is registered with the Food and Drug Administration (FDA) as an analytical laboratory and the Drug Enforcement Administration (DEA). Analytical Research Laboratories operates in compliance with the Good Laboratory Practice (GLP) and Current Good Manufacturing Practice (cGMP) requirements.

Forensics/Legal
As a forensic toxicologist, Dr. Kupiec has provided consultation and expert witness testimony in the field of forensic toxicology and pharmaceutical sciences. He has testified in over 100 cases in municipal, state and federal courts, involving both civil and criminal issues.

Research and Development
ARL works with clients daily, utilizing cutting edge technology to develop products ranging from pharmaceuticals, medical devices and over-the-counter products to take to market. These services range from consultation contract to providing full laboratory services and outsource services for pharmaceutical companies.

There are many services ARL can provide to be a full service laboratory or to compliment your current in-house laboratory to meet your outsourcing needs.

pharmaceutical product testing NDA / ANDA inspection audit services methodology inspectional drug analysis mycoplasmal contamination cell culture biotech outsourcing validation protocols FDA compliance USP 795 797 cGMP consulting Microbial Taxonomy Pharmaceutical Industrial Microbiology Enumeration microorganism testing protocols Medical Device Biotechnology OTC industries biotechnology microbiological drug device home health care pharmacy aseptic manufacturing biological related sterilization manufacturing process design and control quality control quality assurance regulatory affairs engineering process validation method development systems design and implementation management documentation microbiologists sterility assurance and validation Genetic Profiling Bioburden Particulate Analysis Microbial Identification Sterilization Microbiology Antimicrobial Effectiveness (AME) Limulus Ameobocyte Lysate (LAL) USP 795 and 797 compliance USP 71 requirements forensic testimony legal advise

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CCPI - Certified Consultant Pharmacists

Pharmacy Category:
Pharmaceutical Consulting, industrial and environmental microbiology, sterilization, manufacturing process design and control, quality control, quality assurance

Certified Consultant Pharmacists Inc. (CCPI) is a total quality management firm, specializing in Controlled process and quality management strategies for the pharmacy community.

CCPI has over three decades of experience in extemporaneous Pharmacy compounding, cGMP manufacturing, Homecare product preparation, and Hospital clean room applications. CCPI is a leader in regulatory affairs and compliance, and can offer its expertise to assist your organization in bring forth the highest quality preparations and services possible.

We have technical expertise in automated compounding devices, software, and custom compounding methodologies. Through our use of “point of failure” analysis we can develop unique solutions for your practice setting and particular application, enlisting a blend of technical, automation, software and controlled process thinking.

Please visit us today at www.ccpirx.com to see how CCPI can partner with you to make your practice all it can be.

For more information about Certified Consultant Pharmacies, Inc. or to contact us, use the link provided below.

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