Frequently Asked Questions
Get the answers to all your questions here.
PharmaWatch™ is an online service providing 24/7 monitoring, continuous data collection, alerts, and compliance/audit reporting for mission-critical environments such as fridges, freezers, rooms, incubators, etc. in the healthcare industry. 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. Data is stored redundantly across multiple servers and even multiple data centers. This data can then be easily accessed locally or internationally via any internet-connected mobile device providing the user has proper credentials. Furthermore, updates and upgrades are continuous making the most recent, best version of the software always available at no additional cost.
PharmaWatch™ utilizes the highest levels of security as defined by FDA CFR 21 Part 11. This includes:
- SSL/TLS 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 an LTE Cat M1 Cellular Connection. This allows the sensor radio to directly send collected data to the cloud without requiring any further connection to the client’s infrastructure.
Yes. PharmaWatch™ Sensors communicate with the PharmaWatch™ Portal via SSL encrypted communications. Furthermore, the Sensors do not listen. They cannot be contacted directly from the outside. Once every five minutes, each Sensor wakes up, contacts the PharmaWatch™ Ingestion Engine, delivers its data and goes back to sleep. The Sensors can only send to the Ingestion Engine, and this single exchange cannot be tricked into a non-encrypted channel.
Data transmission from the sensors is enabled every five (5) minutes for a duration of less than 100 milliseconds. On average, the traffic including IP and SSL overhead generated by ten sensors will be 3.6 MB during a 24-hour period. The data sent is quite simple, consisting primarily of a unique ID, the time, and the sensor value or values. No customer, patient, or location-specific data is ever transmitted across the Internet from a PharmaWatch™ Sensor.
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-traceable documentation is provided with each monitoring device.
Yes. PharmaWatch™ provides patented data analysis for evaluating, maintaining and complying with CDC pharmaceutical storage requirements.
AmericanPharma Technologies Inc. is a cloud-based technology firm specializing in the healthcare services industry with expertise in regulatory affairs for pharmaceutical and biotechnology companies.