Frequently Asked Questions

AmericanPharma, Inc. is a technology firm specializing in the healthcare services industry with expertise in regulatory affairs for pharmaceutical and biotechnology companies. Our expertise extends from the U.S. market to the Canadian, European, Latin American, Middle Eastern and Asian markets.

PharmaWatch is an online service providing 24/7 monitoring, alerts, reporting and logging of information regarding the storage of mission-critical pharmaceuticals. PharmaWatch is designed to meet 21 CFR Part 11 and 820 compliance in addition to GxP standards and cGMP requirements.

PharmaWatch employs a pay-as-you-go, SaaS (Service-as-a-Software) model so there's minimal equipment to purchase and little or no up-front capital investment.

A cloud architecture requires no on-site server space or software installation and increases the security of the information collected. It also allows data to be accessed locally or internationally via any internet-connected mobile device.

PharmaWatch utilizes the highest levels of security as defined by FDA CFR 21 Part 11. This includes:

  • SSL cryptographic protocols
  • Authentication and authorization credentials limit system access to authorized users
  • User-independent audit trails and logs are time-stamped and maintained
  • Operational system checks insure ongoing security
  • Authenticity, integrity, and confidentiality of all electronic records are maintained in a database designed specifically to meet the performance and security requirements of the health sciences industry
  • Encryption ensures the authenticity, integrity, and confidentiality of all electronic records

Connection to the portal is accomplished via the Internet or cellular system. A wireless access point is configured to receive the signals from the sensors. The client's Internet connection may be utilized to minimize cost and ensure reliability of the data connection. WiFi installations are based on 802.11 standards and data is posted via HPPTS protocol, then ingested, analyzed and retained.

AmericanPharma provides secure communication of environmental monitoring information. By encrypting data and limiting access via the most robust authentication and authorization security credentials in existence today, PharmaWatch meets or exceeds banking level security requirements.

Data transmission from the sensors is enabled every five (5) minutes for a duration of less than 100 milliseconds. The device communicates over Channel 1, 6 or 11. On average, the traffic generated by ten sensors will be 3.6 MB during a 24-hour period.

Yes, the system is easily scalable to accommodate multiple sensing sites, multiple storage units, and multiple storage facilities. Even at the multiple facility scale the user interface makes it simple to access and keep track of logged data.

Yes, alerts can be set according to your preferences.

Alerts can be sent via phone, email, text or pager. Alert preferences can be managed by users from within the web portal.

Yes, PharmaWatch provides traceable calibrated temperature measurement per standards provided by the National Institute of Standards and Technology. (NIST is a U.S. Government agency within the Commerce Department.) NIST-certified documentation is provided with each monitoring device.

Yes. PharmaWatch provides patented data analysis for evaluating, maintaining and complying with CDC pharmaceutical storage requirements.