Clean Room

Control of Equipment

As part of a company’s quality management system, there must be consideration for the equipment used within the facility.  According to the FDA’s 21 CFR 820, “Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked and maintained.”  They also have the requirement that all inspection, measuring and test…

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Part 11 Compliance

As computer usage became more mainstream, especially as a way to store records, the FDA received a request from various industries for guidance on the use of electronic signatures and submissions to the FDA.  The FDA’s response to this request was to issue 21 CFR Part 11 in 1997, which covers electronic signatures, records and…

FDA

Supplier Challenge

Anyone has the ability to review the FDA database of 483’s, warning letters and FDA statements.  Upon reviewing that information, there are essentially eight areas where companies are facing challenges in regards to supplier oversight: Confusion between internal and external suppliers – There has always been confusion in determining whether a company’s other site(s) or…

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Methods for Supplier Evaluation

There are a number of ways to conduct an evaluation of your suppliers.  To begin with, many organizations create a survey in which they outline various questions pertaining to quality systems.  Some companies consider ISO 9001 certification to be the best representation of control over production and quality, and therefore will evaluate the supplier based…

Supplier Management

Supplier Management

Companies that supply a manufacturer with components are a critical part of your manufacturing process.  If you manufacture medical devices, there are numerous requirements for control of these suppliers.  The FDA essentially considers a supplier an extension of the manufacturer, meaning that the service/material supplied must meet pre-established specifications.  According to 21 CFR 820, “Each…

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Management Representative

The FDA has a requirement, in 21 CFR 820.20, for a Management Representative.  This individual “irrespective of other responsibilities, shall have established authority over and responsibility for:  Ensuring that quality system requirements are effectively established and effectively maintained in accordance with this part; and Reporting on the performance of the quality system to management with…