Traceability

Enables tracking of manufacturing of products

Generally, traceability refers to tracking of the manufacturing of products. According to PE 009-14, traceability "required from starting and raw materials, including all substances coming into contact with the cells or tissues through to confirmation of the receipt of the products at the point of use." It also states that "traceability records should be kept as an auditable document and unequivocally linked to the relevant batch record. The storage system should ensure that traceability data allow for easy access." In cleaning validation appropriate documentation (i.e. protocols) is required to maintain traceability throughout the cleaning lifecycle.