End-to-End Temperature Management Solutions

Strategnos is an industry leader in cold chain and temperature management of temperature sensitive pharmaceutical products.
Women assessing cold chain levels
Compliant With

We solve unique and complex challenges in pharmaceutical and FMCG industries.

1, 356

Temperature Mappings Conducted

57, 987

Number of data points analysed

2, 637

Cold Chain Shipment Studies

6, 520

Total Shipment Hours
Strategnos Approach

CAPE: Collect Information Analyse Plan To the power of n

n - Iterate

This approach prioritises key milestones over detailed plans, focusing on achievable goals in iterative sprints. It emphasises continuous improvement, adapting to new information, and addressing backlog items to maintain momentum.

Collect Information

Starting with the end goal in mind. This step involves gathering all relevant data and information about the problem at hand. However, in an agile setting, this may involve more frequent communication with stakeholders and a focus on gathering only the most essential information needed to move forward.

Analyse

This step involves using the information collected in the first step to understand the root causes of the problem and identify potential solutions. A framework for establish a common view of the problems and solutions is establish. This framework becomes the primary reference point going forward keeping all parties on the same page.

Plan

Instead of creating a detailed plan upfront, key milestones are established and the initial "sprint" is planned with achievable deliverables and actions. This keeps the teams focus on the critical value add and allows for initiation of actions sooner than in traditional approaches. Any new opportunities or risks are backlogged.

Execute

In this step, the team begins working on implementing the solution, focusing on delivering a small set of features in each sprint. Regular meetings, called
"stand-ups," are held to track progress and identify any issues that need to be addressed.

Enhances efficiency, reduces costs, and improves customer service through Strategic Alignment and Execution

Cold Chain Packaging Solutions

Temperature and Humidity Calibration

Temperature and Humidity Monitoring

Temperature Mapping

Training and Advisory

Validation and Qualification

Cold Chain Packaging Solutions

Cold Chain Packaging Solutions

We manage the entire process from start to finish and provide audit-ready temperature studies and report with all supporting evidence customised for your container, routes, and operational variation in your supply chain.

Cold Chain Packaging Solutions

Audit-Ready Reports

Using our proprietary methods and software, we provide an audit-ready report, with detailed analysis of the data, interpretation and recommendations, pack out, seasonal configurations and environmental chamber testing.
All studies are conducted in line with local and global standards. All our recording and measuring devices are calibrated to National Standards, on an annual basis.

Have an off-the-shelf container that just isn’t working for you?

Are you worried about the effect of global warming on your supply chain?
We can assist in developing new and cost-effective insulated container solutions and pack-outs using existing container equipment.
Insulated Containers
Vaccine Carriers
PQS testing
PQ testing of containers and cold chain boxes
Validation of processes according to WHO, MCC, PIC/S, ISTA, and ISPE guidelines and requirements and company defined procedures

Cold Chain Packaging Solutions

Need your insulated container solution validated?

Let us help you ensure your cold chain is maintained.
Temperature and Humidity Calibration

Temperature and Humidity Calibration

Let us assist you with the management of all your calibration services to execute calibration of your temperature and humidity monitoring devices

Temperature and Humidity Calibration

Temperature Monitoring Compliance

It is a requirement that all temperature monitoring devices be calibrated on a periodic basis, typically once per year, with traceability to national standards.
Strategnos has strategically partnered with local calibration laboratories to calibrate temperature and humidity recording equipment according to SANAS (South African National Accreditation System), traceable to ILAC (International Laboratory Accreditation Co-Operation).

Comprehensive management of the process, with certificates confirming full compliance with equipment requirements.

Calibration of:
Temperature probes
Humidity probes
Loggers
Ultra-low temperature equipment
Infrared thermometers
Fixed and wireless equipment
Temperature and Humidity Monitoring

Temperature and Humidity Monitoring

Temperature monitoring of shipments is a typical requirement for pharmaceutical product distribution.

Is your warehouse, cold room, freezer or insulated container monitored for temperature or humidity in the correct locations?

Temperature and Humidity Monitoring

End-to-End Monitoring Report Solutions

We provide audit-ready temperature monitoring reports, with detailed analysis of the data, and OOS (Out of Specification) results above or below the acceptance criteria with our proprietary methods and software, tailored to your equipment.
Calibration of:
Management of collected data
Data must be accessible
Data must be traceable
Supported by calibration certificates
Data should be reviewed and analysed for any corrective action

We can supply reporting by shipment, weekly, monthly, quarterly or yearly, tailored to your requirements.

Analysis by route, branch and season.
Data can be categorised and linked to relevant calibration certificates.
Audit-ready reports with suggested corrective action where appropriate.
Temperature Mapping

Temperature Mapping

We always go one step further to provide the best practical advice on how to interpret temperature-related data and what the data means for your facility

Temperature Mapping

Tailored Temperature Mapping Protocols and Reports

We oversee the entire process, delivering a tailored temperature mapping protocol and report, identifying hot and cold spots for monitoring, pivot positions, and ensuring acceptance criteria are met.

Utilising our methods and software, we furnish an audit-ready report, analysing data, offering insights, and adhering to standards. Our recording devices are annually calibrated to National Standards.

More Than Just Temperature Mapping Data

We oversee the entire process, delivering a tailored temperature mapping protocol and report, identifying hot and cold spots for monitoring, pivot positions, and ensuring acceptance criteria are met.

Utilising our methods and software, we furnish an audit-ready report, analysing data, offering insights, and adhering to standards. Our recording devices are annually calibrated to National Standards.
Air Freight Shipments (2°C to 8 °C) to local and international locations
Warehouses (15 °C to 25 °C)
Freezers (-20 °C to -80 °C)
Fridge and Cold-rooms (2°C to 8 °C)
Insulated Containers (2°C to 8 °C)
Refrigerated and Temperature Controlled Vehicles
Reefer Containers
Hot Tunnels and Stability Chambers

Six Key Elements to a Quality Temperature Mapping Exercise:

01 - Assess the environment

Prior to temperature mapping to ensure the equipment passes the temperature mapping (current set point, temperature monitoring data, when was the last service, etc.)

02 - Data integrity

Ensuring that data collected from temperature loggers is traceable and complies to data integrity principles.

03 - Measuring and Recording Equipment

Wired, wireless or Bluetooth loggers? Ensure the use of correct devices for the environment – operating range, accuracy, device resolution.

04 - More than just data

The results collected from the temperature mapping; exercise should be analysed including observations and recommendations to assess trends, as well as Hot Spots and Cold Spots for temperature monitoring locations.

05 - Quality and Technical Probe Review

An independent Quality review should be conducted to ensure that appropriate procedures have been executed, key records are available and data integrity has been maintained. Furthermore a Technical review should interpret the results of the mapping and provide observations and recommendations.

06 - Calibration

Data loggers used for the mapping exercise should be calibrated at 3 points (which should cover the range of the unit being mapped), the calibration should be traceable to national standards. Factory calibration should be avoided..

Training and Advisory

Training and Advisory

Let us assist your organisation and get to grips with the technicalities of the regulatory landscape for both local and international requirements.

Our trainers are Subject Matter Experts providing in-depth and practical guidance on what is required for all organisational levels.

Interactive Sessions and Training Workshops

Discussions around up to date guidance, regulatory changes, industry trends and common audit items.
Cold chain fundamentals and temperature management
Validation and Qualification
System validation
Insulated container validation
Risk Management
Good Cold Chain Management Practices.
Good Warehouse Practices for distribution and wholesaling environments Regulations, Standards and Guidelines.
Validation and Qualification

Validation and Qualification

With an increased regulatory focus on validation and qualification, we follow best practice guidelines to write and execute protocol to meet regulatory requirements.

Validation and Qualification

Validation and Qualification Protocols and Reports

We manage the entire process from start to finish and provide an audit-ready validation/ qualification protocol and report with all supporting evidence, working with our Clients to show the desired parameters have been achieved.

Compliant Validation Process

Validation of processes according to WHO, SAHPRA and PDA guidelines and requirements, GAMP, FDA, CFR 21 and company defined procedures
Equipment and facilities such as:
warehouses
fridges
cold rooms
freezer rooms
freezers
ultra-low freezers
vehicles
hot tunnels
stability chambers
incubators
autoclaves
Processes and systems, including:
Insulated containers
vaccine carriers
PQS testing and PQ testing of containers and cold chain boxes
IT systems and temperature and humidity monitoring systems
ERP systems
BMS systems
Temperature Management Solutions

Our Clients