BOM Software Systems


Use of BOM Software for Compliance

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.

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BOM Software for Medical Device Companies

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 Pharmaceutical Companies

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’s BOM Software Solution Helps Ensure Compliance and Efficiency

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:

Increased Efficiency, Fewer Errors:

Companies whose BOM systems consist mainly of spreadsheets know that manual data entry is tedious and prone to mistakes, especially when the process involves outside stakeholders such as CROs and suppliers.

Improved Communication:

A manual BOM process would entail sending email, calling, and faxing documents to suppliers, CROs, and outside stakeholders. Such uncoordinated efforts could cause delays in obtaining parts and also miscommunication. MasterControl’s BOM software solution automates the entire process so communication is instantaneous and includes all relevant users.

Effective Document Control:

The MasterControl BOM system will integrate document control, which means revisions will be traceable and users will be able to access only the approved document, eliminating the likelihood of using obsolete documents or unapproved drafts.

Automatic Updates:

With MasterControl’s BOM software solution, your list of components and materials will be automatically updated with every revision.

Synchronized BOMs:

MasterControl’s BOM software solution will keep your engineering BOM data in sync with manufacturing BOM data because MasterControl enables the BOM system to integrate with ERP systems.

For More Information on BOM Software

For more information about the bill of materials or BOM software, please feel free to contact a MasterControl representative.