The bill of material (BOM)—which represents the components of a product and the materials that make up the components—is important for all manufacturers, but it’s particularly critical for regulated companies such as those under the jurisdiction of the U.S. Food and Drug Administration (FDA). Product quality could be greatly affected by a noncompliant system for BOM management. Most pharmaceutical, medical device, and other FDA-regulated companies use BOM software (or BOM system) to address not only their manufacturing needs but also their compliance requirements.
The most popular BOM software available in the market today addresses regulations such as 21 CFR Part 820, which applies to medical device manufacturers, as well as their suppliers.
Under 21 CFR Part 820, BOM is among the documents that comprise the Device Master Record. As defined by this regulation, BOM is a list of components usually arranged by subassembly or other subproduct level or by process steps. A robust BOM software solution should provide tools that facilitate the creation, revision, and timely distribution of the document.
BOM software for the pharmaceutical sector is based largely on existing regulations such as 21 CFR Part 211, the primary regulation that applies to FDA-regulated pharmaceutical companies.
Under 21 CFR Part 211, pharmaceutical companies and their CROs and suppliers are required to control components of their drug products as part of their overall quality management efforts. An effective BOM system must facilitate the creation, revision, review, and approval of the list of components and also provide the capability to track revisions.
MasterControl BOM is an easy-to-use software solution for automating, standardizing, and streamlining the BOM process. With MasterControl, you will be able to attain the following:
For more information about the bill of materials or BOM software, please feel free to contact a MasterControl representative.