Environmental control

Pharmaceutical and chemical companies must manage physical samples to monitor environmental factors and identify potential risks. Samples are pulled from multiple sampling points corresponding to a network of strategic points around the site. This is meant to ensure product quality, avoid risk for consumers, and support reducing the cost of recalling contaminated products. Water, air, and surfaces need to be tested periodically to prevent healthcare-associated infections (HAI) and control the spread of bacteria, yeasts, and molds.

Life Sciences Quality Control & Assurance provides the capability to:

1. Manage environmental control by integrating with the Project Management and Accounting module to trace the full timeline, including planning and execution of the environmental control. An environmental control project may consist of multiple levels:

   1. Header project corresponding to the environmental factor (e.g., water)

   2. Sub-projects for each time point

   3. Sub-sub-projects for each sampling point.

2. Define an environmental control schedule with a list of tests to be executed at each time point (including the definition of the proper range of recurrence and recurrence pattern for the time point) for each sampling point.

3. Configure quality associations to automatically generate quality orders against the environmental control project.

4. Create quality orders according to the quality associations defined above.

Environmental control schedule

Environmental control schedules are set up in Life Sciences Quality Control & Assurance > Setup > Quality control > Test groups by creating test groups that must include:

• The full list of tests to be executed during the entire environmental control protocol;

• A quality schedule defining the list of tests to be executed for the sampling point/time point combinations.

Environmental control project

A multi-level project structure for environmental control can be set up in Project management and accounting > Projects > All projects. For any sub-project or sub-sub-project, it is possible to specify the associated sampling point in the Sampling point field.

The sampling point set by the user at (any) project level is inherited in the Item requirements form whenever creating new lines. If the sampling point at the project level is blank, it is possible to specify the sampling point directly in the Item requirements form.

A possible project structure for environmental control is the following:

• Project header PROJ001: Environmental control

  • Sub- project PROJ001-001: Water testing

    • Sub-sub project PROJ001-001-001: Sampling point 1

      • Item requirement: Item Water, Site, Warehouse, Batch, Daily

    • Sub-sub project PROJ001-001-002: Sampling point 2

      • Item requirement: Item Water, Site, Warehouse, Batch, Daily

STAEDEAN Life Sciences projects for environmental control leverage standard Microsoft Dynamics 365 Finance & Supply Chain Management Project Management and Accounting functionalities.

Environmental control schedule generation

Item requirements can be created for the samples to be tested.

For each item requirement line, it is possible to:

1. Create planned quality orders by clicking the Planned quality orders button. The scheduling date (i.e., the start date for the generation of the planned quality order for the stability study) and the end date (i.e., the last date for the generation of the planned quality order for the project) must be entered;NOTE: To support project management activities, the system provides the capability to create a project work breakdown structure (WBS), including the list of environmental control quality orders with relevant start and end date information. The WBS can be easily exported to Microsoft Project, enabling the Transfer to WBS checkbox. For the WBS to be correctly populated, it is necessary to define a Default project category in Life Sciences Quality Control & Assurance > Life Sciences Quality Control & Assurance parameters > General tab. The transaction type for the project category must be “Hour”.

2. Review and approve the planned quality orders by clicking the Create quality orders button. Once this is done, quality orders for environmental control are generated and displayed in the list of quality orders in Life Sciences Quality Control & Assurance > Quality management > Quality orders.

Note

In case actual quality orders have already been created and the user tries to generate additional quality orders for the same item requirement line by using the same Scheduling date and End date combination or a combination of dates which is partially overlapping the one used previously, the system will return an error message and prevent the creation of the planned quality orders.

Example

Company Contoso would like to manage environmental control within the ERP system. In particular, the Company is monitoring purified water and passive air by pulling samples and executing a set of tests daily, every Monday and every Friday.

The following sampling points are defined in the Sampling points form:

• “SP1” (Sampling point 1)

• “SP2” (Sampling point 2)

Quality schedule type “ENV” is configured with Enable recurrence and Enable sampling point set to “Yes”. The following time points are defined in the Time points form:

Tests are set as follows:

Test group “Environmental control”, including all tests listed above, has the Quality schedule checkbox ticked, and the quality schedule is configured as follows:

A quality association is set as follows:

• Reference type: “Project”;

• Item: “Water”;

• Test group: “Environmental control”.

A possible project structure is as follows:

• PROJ001: Environmental control

  • PROJ001-001: Water testing

    • PROJ001-001-001: Sampling point 1

      • Item requirement: Item Water, Site 1, Warehouse WH25, Batch B001

      • Item requirement: Item Water, Site 1, Warehouse WH25, Batch B002

      • Item requirement: Item Water, Site 1, Warehouse WH25, Batch B003

    • PROJ001-001-002: Sampling point 2

      • Item requirement: Item Water, Site 1, Warehouse WH25, Batch B004

      • Item requirement: Item Water, Site 1, Warehouse WH25, Batch B005

      • Item requirement: Item Water, Site 1, Warehouse WH25, Batch B006

For each item requirement line, the user will create quality orders for each storage sampling/time point combination set in the environmental control schedule.

Planned quality orders for the first item requirement line, scheduling date set to “28^th Jan. 2023″ and end date set to “3^rd Feb 2023″: