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.
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
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
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.
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.
"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
Have one of our experts assist with the best solution for your business.
Temperature Management Solutions
Our Clients
