Electronic records--theircreation, modification, maintenance, retrieval, and archiving--can create ongoing challenges for all organizations. For industries regulated by the U.S. Food and Drug Administration (FDA), such as pharmaceutical companies, medical device manufacturers, food processing plants, and biotech companies, the FDA’s Code of Federal Regulations Title 21 Part 11 applies to the specifications, use, and control of electronic records and electronic signatures.

The requirements of FDA 21 CFR Part 11 for electronic records are based on good practices, organization, and, most of all, common sense to ensure the efficient and secure handling of these records. In general, these requirements state that:

• All information is complete, and all records can be tracked to their originator and corresponding records.

• Appropriate securities are in place to ensure that tampering that would alter the record from its original intent does not take place.

• Only the appropriate parties can access the records, and only those so identified can create, modify, or review those records.

The need for control over manufacturing processes has never been higher than in today's environment. As this need has increased, so too has the requirement for better management of the equipment used to measure and control manufacturing processes. Fundamental to managing this equipment properly is ensuring that it's correctly calibrated and maintained.

Unfortunately, while many managers are faced with managing a growing number of instruments and increased responsibility, their resources are being reduced. One popular method for minimizing the resources necessary is the implementation of commercial off-the-shelf calibration-management software (CMS).

“We are going to win, and the industrial West is going to lose: There’s nothing much you can do about it because the reasons for your failure are within yourselves.”

--Konosuke Matsushita  

They work tirelessly to change our world irreversibly. If they succeed at what they’re doing and aren’t challenged, our way of life as we know it will end. While we whine about our bosses, our organizations, and our government; while we do the minimum that our jobs require; while we flip-flop through the mall and watch Oprah they’re planning, learning, and executing. When we’re tucked away in our beds, tossing and turning in restless sleep, they’re even busier. They don’t seem to tire; their passion is relentless. To them, weekends and holidays are inconsequential in their desire to have what we have.

We’re at war, but we seem oblivious to it. Our children’s future, our families, even our liberties are at risk, but for now, apathy is our primary defense. Secure in our ignorance of what’s happening far away, we think that we’re safe. But we’re not.