Aberdeen: Paper-Based Systems are no Way to Run Quality Management

A recent report from leading research firm Aberdeen Group says too many small and medium sized manufacturers are relying on outdated and inefficient paper-based methods to run their quality management. The result is lower productivity, significantly less visibility into product development, and increased likelihood of making a mistake that can alienate a customer or raise the wrath of a regulatory agency.

Quality management affects many aspects of the manufacturing process. It monitors materials and parts usage from the supply chain, it supports regulatory reporting, and it often is a key aspect of a process audit trail. When some parts of product development are automated (such as design or Bill of Materials generation) and other parts are not, it causes an inefficient workflow that slows down important and timely inquiries, and it makes it more difficult to document the full spectrum of product development. Read More

What the Volkswagen Scandal Teaches About the Value of Compliance Management

For years industry analysts and software developers have affirmed the value of tracking compliance as a product design data element, but there is nothing like a big international scandal to change the discussion. Volkswagen was recently caught cheating on emissions tests on diesel engines sold in the US, and has set aside €6.5 billion ($7.3 billion) to deal with the aftermath. International bank Credit Suisse thinks the damage will more likely cost VW €78 billion ($87 billion) over time, in the indirect form of lost sales from its damaged reputation as well as the direct form of fines, legal fees, and possible sales bans. Read More

Fighting Medical Regulatory Bureaucracy with PDM

MedicaMetrix is a US-based startup in the medical devices industry. It is an industry notorious for chewing up and spitting out small companies like a monster finding bad grapes in a vineyard. Founder-CEO Christopher LaFarge says investors in his industry look for leaders “who will run through brick walls head first” among other attributes. “Somehow, they are going to end up in the market with something that makes money,” no matter what it takes.

One of the frustrations in developing new medical devices is the “alphanumeric soup” of regulatory and compliance agencies. There is the FDA in the US, and an equivalent agency for European Union nations. Each agency wants an incredible amount of documentation, presented their way. While there is some overlap, they both want schematics and circuit board designs, CAD file prints of the product, and all the accompanying documentation generated in word processing, spreadsheets, accounting, and other software presented in a specific way. Read More