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capability_7

CA 7: Media, Reagents, Controls: Manufacturing and Inventory

This capability area addresses informatics capabilities related to the use of electronic and real-time management of all inventory-related activities within the laboratory.

Guidance Statement

Purpose: Laboratories are responsible for meeting logistical demands tied to their operational activities. Examples include providing materials for sample collection, sample transportation emergency response, and producing packaging for the needed chemicals, media, reagents, stains, controls, and kits. Whether this production is carried out by the laboratory or by third party suppliers, the laboratory may require the ability to provide these resources in adequate quantities based on laboratory need and in coordination with the inventory, supply, and logistics activities within the laboratory.

What: This capability area addresses informatics capabilities related to the receiving and processing of orders from internal laboratory sections and inventory control, lot manufacturing that may require other items to be manufactured to assemble the final ordered item, and creation of Quality Control data sets linked to each item or batch manufactured. It includes the use of informatics to associate QC data sets to inventory lots, trigger in-house manufacturing of items, sell inventory items to other laboratories, and track maximum and minimum inventory levels of items used in testing.

How: The ability to electronically track and forecast inventory and supply levels, as well as testing demands within the laboratory helps guide laboratories to begin inhouse production of needed materials, and to identify the need for raw materials and other supplies.

From a process perspective, the laboratory management system would benefit from being able to effectively track the quantity, quality, location/storage, and oversight of all laboratory materials relevant to the manufacturing process across the relevant phases of the manufacturing lifecycle. The relevant steps in the product manufacturing lifecycle are:

  • Formulation/design
  • Planning (needs forecasts)
  • Procurement
  • Manufacture/production
  • Quality testing
  • Use, sale, or disposal/destruction

The system should be able to track product quality as products are used, moved, or stored for the duration of their shelf life, and provide alerts and information to initiate relevant action based on the state of these materials. The LIMS thus links manufacturing with the following functions: procurement, inventory, logistics, supplies, testing, quality management, accounts, and waste management. The information provided by the system can also be used to monitor the availability and cost effectiveness of in-house manufacturing.


Capability Statement #7.1

Capability Statement Level Description of Level
Capability Statement #7.1 The laboratory is able to electronically track, manage, and maintain inventory, including maximum and minimum inventory levels for items used in testing, such as chemicals, media, reagents, control, etc. Level 3 The laboratory is able to electronically track, manage, and maintain inventory, including maximum and minimum inventory levels for items used in testing.
Level 2 The laboratory is able to track, manage, and maintain inventory levels partly electronically and partly manually.
Level 1 The laboratory has only manual inventory tracking capability.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #7.2

Capability Statement Level Description of Level
Capability Statement #7.2 The laboratory management systems are able to associate Quality Control (QC) data sets to inventory items and lots in an automated manner (e.g., batches or items manufactured, QC information, replace output by expiration dates). Level 3 The laboratory management systems are able to perform this function in an automated manner.
Level 2 The laboratory management systems are able to perform this function in a partly automated manner.
Level 1 The laboratory uses a paper-based system to perform these functions.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

Capability Statement #7.3

Capability Statement Level Description of Level
Capability Statement #7.3 The laboratory management systems a) automate the control of manufacturing protocols; b) store and maintain electronic formulae of raw ingredients needed for manufacturing; and c) track lot information, including re-inventorying finished goods and synchronization with raw materials usage in the inventory system. Level 3 The laboratory management systems are able to perform all of these functions.
Level 2 The laboratory management systems are able to perform some of these functions.
Level 1 The laboratory uses a paper-based system to perform these functions.
N/A Not applicable to this laboratory.
Required Drupal 8 Modules

capability_7.txt · Last modified: 2016/12/31 22:04 by awake