A Business Management System provides a platform to record all business processes for reference and training of current and future staff members. This allows for standardized execution of processes for effectiveness and efficiency. The Business Management System provides a central repository of all business structures, job descriptions, processes, procedures, work instructions, forms and records to ensure consistent process execution and customer service.

Benefits:

• Documentation of current business process
• Alignment of staff to business processes to achieve the business objectives
• Improved team synergy
• Business continuity for improved succession planning

A typical problem in most companies is having too much inventory of what is not required and not enough of the required inventory. Based on sound inventory and demand planning principles, current inventory levels are analysed to determine the optimal order and inventory on hand quantities. The objective being to improve service levels and optimize cash flow.

Benefits:

• Improved Service Levels
• Reduction in redundant stock
• Reduce investment in stock (Free up working capital)

Ensuring an effective strategic meeting or workshop can be a challenge. In some cases, it

requires an effective facilitator to  ensure that the discussion does not stray from meeting its

objectives, all parties have an opportunity to be heard and outcomes are documented with

specific responsibilities and dates. Strategnos provides experienced facilitators to oversee

such meetings and workshops to ensure that these are run in a structured manner, that

conversation and input is integrated and formally documented to ensure that the objectives are met

Benefits:

• Strategic Facilitation
• Organisation Change Management
• Change Management
• IT implementation facilitation
• Crisis Management
• Supplier and Customer Alignment

It is a requirement of both local and international guidelines that warehouses, cold rooms and freezers used to store pharmaceutical products be mapped for temperature on a periodic basis. Using our proprietary methods and software, we provide an audit ready report, with detailed analysis of the data, interpretation and recommendations. All mapping activities are conducted in-line with local and global standards. All recording devices are calibrated to National Standards, on an annual basis. We typically map the following equipment:

• Warehouses (15 °C to 25 °C)
• Freezers (-20 °C to -80 °C)
• Fridge and Cold-rooms (2°C to 8 °C)
• Supply Chain Vehicles (Fine Distribution and Line Haul Vehicles)
• Air Freight Shipments (2°C to 8 °C) to local and international locations
• Insulated Containers (2°C to 8 °C)
• Reefer Containers
• Hot Tunnels and Stability Chambers
• Most other mapping requirements

With the increased regulatory focus on validation and qualification, we follow best practice guidelines to write and execute appropriate protocols to meet regulatory requirements. We manage the entire process from start to finish and provide an audit ready validation/ qualification protocol and report with all supporting evidence.

Benefits:

• Validation/ Qualification of:
  • Equipment and facilities such as: warehouses, fridges, cold rooms, freezers, ultra-low freezers, vehicles, hot tunnels, stability chambers etc.
  • Insulated containers
  • IT systems and temperature and humidity monitoring systems
• Validation of processes according to WHO, MCC and PDA guidelines and requirements, GAMP, FDA 21 CFR etc. and company defined procedures
• Component Qualification (CQ).
• Design Qualification (DQ).
• Installation Qualification (IQ).
• Operational Qualification (OQ).
• Performance Qualification (PQ).

Temperature monitoring of shipments is a typical requirement for pharmaceutical product distribution. A fundamental challenge with this, however, is the management of the data collected. The data must be accessible, traceable and supported by calibration certificates. Furthermore, the data should be reviewed and analysed for any corrective action required. Strategnos provides reporting solutions which allow for:

• Data to be categorised and linked to relevant calibration certificates.
• Reporting capabilities allow for analysis by route, branch and season.
• Reports are compiled into audit ready reports with suggested corrective action where appropriate.

It is a requirement that all temperature monitoring devices be calibrated on a periodic basis, typically once per year, with traceability to national standards.  The management of the process can become onerous.  Failure to effectively manage this process could result in non compliance and patient risk . Strategnos therefore offers oversight services to manage and execute calibration of temperature monitoring devices.

Note: This service is available only for clients who enter into a Service Level Agreement for other services within the Cold Chain environment.

This service offers clients an end to end managed solution across the following elements within the health science industry:

• Calibration
• Mapping
• Validation and Qualification

All schedules and execution are fully managed by Strategnos in consultation with the Client.

• Good Cold Chain Management Practices.
• Regulations, Standards and Guidelines.
• Mapping, Validation and Qualification.

Managing and maintaining a Quality Management System (QMS) in line with any of the above standards or guidelines is a challenging task. Ensure proper document control and standardization is key. Strategnos can assist clients in ensuring that the QMS is maintained and up to date all times in an audit ready state.