Maritime Service
Can a DeltaTrak PDF data logger become infected with a computer virus? To answer this question, let’s take a look at what is a computer virus, based on what it does: 1) It attaches itself to computer files (i.e. applications, documents and procedures); 2) Once opened, it gives a computer a set of instructions; 3) It replicates itself; 4) It carries a malicious function, such as changing/corrupting files, or accessing passwords. As we can see, a computer virus is largely defined by how it functions.
- George Krastev
- Category: Compliance and Risk Management
- 2713
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George joined DeltaTrak in 1997 as an Electronic Technician/Design Engineer and currently holds the position of Vice President of Research and Development.
George's Recent Articles
Did you realize that DeltaTrak can serve as your one-stop shop for calibrating all of your DeltaTrak products?
For years, customers have turned to the calibration and certification services offered by DeltaTrak. All DeltaTrak calibration is completed using high quality measurement instruments certified against National Institute of Standards and Technology (N.I.S.T) by a primary standards laboratory.
- DeltaTrak Tech Support Team
- Category: Compliance and Risk Management
- 4342
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Through the blog, the DeltaTrak Support Team will discuss key programs such as Calibration services, the Product Emulation feature, and various FAQs.
View the Tech Support Team's profile
Tech Support Team's Recent Articles
As the regulations for food and pharma' get closer together in nature an overarching guidance is emerging which is related to risk aversion and risk mitigation planning.
- Peter Norton
- Category: Compliance and Risk Management
- 7449
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Peter Norton is a senior logistics and supply chain manager who is a consultant hired by clients in both the life science industry, and the food supply industry. Peter has extensive experience in both the domestic US and global markets specifically in the areas of cold chain management and security as this relates to the pharmaceutical industry to insure drugs that are supplied to the patient are at the required stability levels and peak efficacy.
Peter's Recent Articles
- Imagine the Quality advantage of Drug Serialization compliance linked with Cold Chain monitoring?
- Block Chain and The Supply Chain – Produce and/or Life Sciences
- Produce Quality Code can offer a better indicator to Shelf Life
- Transit Data Recorders move from PC to Mobile
- Risk Assessment and Mitigation Planning - Are you covered?
- DeltaTrak Debuts New Mini PDF In-Transit Logger
- Are you truly 21CFR Part11 compliant?
- Remote Wireless Refrigerator Monitoring
- FSMA - are you prepared?
- Smart Solutions for the Last Mile, or Patient Mile!
- The Importance of being up to date on regulatory compliance - Globally!
- Cloud Computing & Visibility Solutions
- DeltaTrak Cuts Costs in Cold Chain Logistics
- DeltaTrak's 75-Day USB In Transit Export Logger
- The Global Importance of the Chinese FDA GSP Regulations
- How Do You Rate or Qualify Your Vendors and Suppliers?
- Big Data - Who Controls and what do you want to see?
- Beyond the Last Mile - Who controls this?
- IQPC 2014 (September 29th to October 3rd) Review of Events
- Serialization - Track and Trace - Don't forget the cold chain
- Prep for Flu Season: Temperature Monitoring and DeltaTrak’s Vaccine Data Logger with Glycol Bottle
- The reports are in: - "What causes most Cold Chain monitoring failures"
- Impact of Severe Weather Conditions on Biological Products
- CDC Vaccines For Children (VFC) and Immunization Programs - US State Level
- FDA - Includes Drugs and Food regulation
- GDP Compliance to meet new regulation introduced within the EU in March-2013
- Time Out of Refrigeration (TOR) considerations
- MKT - To be used, or not to be used?
- Risk Assessment and Risk Mitigation planning Webinar
I guess by now the rumors are true and the FDA has recently (late 2015) announced that it will begin much more stringent inspections for compliance to 21 CFR Part 11 regulations related to and concerning electronic records, audit trails concerning metadata, and signatures that need to be actual and trustworthy, plus validation of products.
- Peter Norton
- Category: Compliance and Risk Management
- 8107
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Peter Norton is a senior logistics and supply chain manager who is a consultant hired by clients in both the life science industry, and the food supply industry. Peter has extensive experience in both the domestic US and global markets specifically in the areas of cold chain management and security as this relates to the pharmaceutical industry to insure drugs that are supplied to the patient are at the required stability levels and peak efficacy.
Peter's Recent Articles
- Imagine the Quality advantage of Drug Serialization compliance linked with Cold Chain monitoring?
- Block Chain and The Supply Chain – Produce and/or Life Sciences
- Produce Quality Code can offer a better indicator to Shelf Life
- Transit Data Recorders move from PC to Mobile
- Risk Assessment and Mitigation Planning - Are you covered?
- DeltaTrak Debuts New Mini PDF In-Transit Logger
- Are you truly 21CFR Part11 compliant?
- Remote Wireless Refrigerator Monitoring
- FSMA - are you prepared?
- Smart Solutions for the Last Mile, or Patient Mile!
- The Importance of being up to date on regulatory compliance - Globally!
- Cloud Computing & Visibility Solutions
- DeltaTrak Cuts Costs in Cold Chain Logistics
- DeltaTrak's 75-Day USB In Transit Export Logger
- The Global Importance of the Chinese FDA GSP Regulations
- How Do You Rate or Qualify Your Vendors and Suppliers?
- Big Data - Who Controls and what do you want to see?
- Beyond the Last Mile - Who controls this?
- IQPC 2014 (September 29th to October 3rd) Review of Events
- Serialization - Track and Trace - Don't forget the cold chain
- Prep for Flu Season: Temperature Monitoring and DeltaTrak’s Vaccine Data Logger with Glycol Bottle
- The reports are in: - "What causes most Cold Chain monitoring failures"
- Impact of Severe Weather Conditions on Biological Products
- CDC Vaccines For Children (VFC) and Immunization Programs - US State Level
- FDA - Includes Drugs and Food regulation
- GDP Compliance to meet new regulation introduced within the EU in March-2013
- Time Out of Refrigeration (TOR) considerations
- MKT - To be used, or not to be used?
- Risk Assessment and Risk Mitigation planning Webinar
The ICH and other globally focused organizations are working diligently to introduce more consolidated forms of quality regulations, like the ICH Q10, for the management of the quality of drugs related to cold chain distribution and drug security.
- Peter Norton
- Category: Compliance and Risk Management
- 7331
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Peter Norton is a senior logistics and supply chain manager who is a consultant hired by clients in both the life science industry, and the food supply industry. Peter has extensive experience in both the domestic US and global markets specifically in the areas of cold chain management and security as this relates to the pharmaceutical industry to insure drugs that are supplied to the patient are at the required stability levels and peak efficacy.
Peter's Recent Articles
- Imagine the Quality advantage of Drug Serialization compliance linked with Cold Chain monitoring?
- Block Chain and The Supply Chain – Produce and/or Life Sciences
- Produce Quality Code can offer a better indicator to Shelf Life
- Transit Data Recorders move from PC to Mobile
- Risk Assessment and Mitigation Planning - Are you covered?
- DeltaTrak Debuts New Mini PDF In-Transit Logger
- Are you truly 21CFR Part11 compliant?
- Remote Wireless Refrigerator Monitoring
- FSMA - are you prepared?
- Smart Solutions for the Last Mile, or Patient Mile!
- The Importance of being up to date on regulatory compliance - Globally!
- Cloud Computing & Visibility Solutions
- DeltaTrak Cuts Costs in Cold Chain Logistics
- DeltaTrak's 75-Day USB In Transit Export Logger
- The Global Importance of the Chinese FDA GSP Regulations
- How Do You Rate or Qualify Your Vendors and Suppliers?
- Big Data - Who Controls and what do you want to see?
- Beyond the Last Mile - Who controls this?
- IQPC 2014 (September 29th to October 3rd) Review of Events
- Serialization - Track and Trace - Don't forget the cold chain
- Prep for Flu Season: Temperature Monitoring and DeltaTrak’s Vaccine Data Logger with Glycol Bottle
- The reports are in: - "What causes most Cold Chain monitoring failures"
- Impact of Severe Weather Conditions on Biological Products
- CDC Vaccines For Children (VFC) and Immunization Programs - US State Level
- FDA - Includes Drugs and Food regulation
- GDP Compliance to meet new regulation introduced within the EU in March-2013
- Time Out of Refrigeration (TOR) considerations
- MKT - To be used, or not to be used?
- Risk Assessment and Risk Mitigation planning Webinar
When any QA department turns their attention to data and security most of the focus is on how this is controlled internally in relation to common regulations like - 21 CFR Part11, Part 820, GMP, etc., and of course patient data regulations like HIPAA.
- Peter Norton
- Category: Compliance and Risk Management
- 8234
-
Peter Norton is a senior logistics and supply chain manager who is a consultant hired by clients in both the life science industry, and the food supply industry. Peter has extensive experience in both the domestic US and global markets specifically in the areas of cold chain management and security as this relates to the pharmaceutical industry to insure drugs that are supplied to the patient are at the required stability levels and peak efficacy.
Peter's Recent Articles
- Imagine the Quality advantage of Drug Serialization compliance linked with Cold Chain monitoring?
- Block Chain and The Supply Chain – Produce and/or Life Sciences
- Produce Quality Code can offer a better indicator to Shelf Life
- Transit Data Recorders move from PC to Mobile
- Risk Assessment and Mitigation Planning - Are you covered?
- DeltaTrak Debuts New Mini PDF In-Transit Logger
- Are you truly 21CFR Part11 compliant?
- Remote Wireless Refrigerator Monitoring
- FSMA - are you prepared?
- Smart Solutions for the Last Mile, or Patient Mile!
- The Importance of being up to date on regulatory compliance - Globally!
- Cloud Computing & Visibility Solutions
- DeltaTrak Cuts Costs in Cold Chain Logistics
- DeltaTrak's 75-Day USB In Transit Export Logger
- The Global Importance of the Chinese FDA GSP Regulations
- How Do You Rate or Qualify Your Vendors and Suppliers?
- Big Data - Who Controls and what do you want to see?
- Beyond the Last Mile - Who controls this?
- IQPC 2014 (September 29th to October 3rd) Review of Events
- Serialization - Track and Trace - Don't forget the cold chain
- Prep for Flu Season: Temperature Monitoring and DeltaTrak’s Vaccine Data Logger with Glycol Bottle
- The reports are in: - "What causes most Cold Chain monitoring failures"
- Impact of Severe Weather Conditions on Biological Products
- CDC Vaccines For Children (VFC) and Immunization Programs - US State Level
- FDA - Includes Drugs and Food regulation
- GDP Compliance to meet new regulation introduced within the EU in March-2013
- Time Out of Refrigeration (TOR) considerations
- MKT - To be used, or not to be used?
- Risk Assessment and Risk Mitigation planning Webinar
In March of 2013 in the EU the EMA introduced a new guideline related to Good Distribution Practices (GDP) and in June of 2013 the Chinese FDA introduced a new guideline related to Good Supply Practices (GSP).
- Peter Norton
- Category: Compliance and Risk Management
- 10531
-
Peter Norton is a senior logistics and supply chain manager who is a consultant hired by clients in both the life science industry, and the food supply industry. Peter has extensive experience in both the domestic US and global markets specifically in the areas of cold chain management and security as this relates to the pharmaceutical industry to insure drugs that are supplied to the patient are at the required stability levels and peak efficacy.
Peter's Recent Articles
- Imagine the Quality advantage of Drug Serialization compliance linked with Cold Chain monitoring?
- Block Chain and The Supply Chain – Produce and/or Life Sciences
- Produce Quality Code can offer a better indicator to Shelf Life
- Transit Data Recorders move from PC to Mobile
- Risk Assessment and Mitigation Planning - Are you covered?
- DeltaTrak Debuts New Mini PDF In-Transit Logger
- Are you truly 21CFR Part11 compliant?
- Remote Wireless Refrigerator Monitoring
- FSMA - are you prepared?
- Smart Solutions for the Last Mile, or Patient Mile!
- The Importance of being up to date on regulatory compliance - Globally!
- Cloud Computing & Visibility Solutions
- DeltaTrak Cuts Costs in Cold Chain Logistics
- DeltaTrak's 75-Day USB In Transit Export Logger
- The Global Importance of the Chinese FDA GSP Regulations
- How Do You Rate or Qualify Your Vendors and Suppliers?
- Big Data - Who Controls and what do you want to see?
- Beyond the Last Mile - Who controls this?
- IQPC 2014 (September 29th to October 3rd) Review of Events
- Serialization - Track and Trace - Don't forget the cold chain
- Prep for Flu Season: Temperature Monitoring and DeltaTrak’s Vaccine Data Logger with Glycol Bottle
- The reports are in: - "What causes most Cold Chain monitoring failures"
- Impact of Severe Weather Conditions on Biological Products
- CDC Vaccines For Children (VFC) and Immunization Programs - US State Level
- FDA - Includes Drugs and Food regulation
- GDP Compliance to meet new regulation introduced within the EU in March-2013
- Time Out of Refrigeration (TOR) considerations
- MKT - To be used, or not to be used?
- Risk Assessment and Risk Mitigation planning Webinar
