FDA Regulatory Compliance Affects All Aspects of Manufacturing… for the Better
by Ryan Szporer
There’s a saying: “Winning isn’t everything; It’s the only thing.” In business however, before you can win, you have to first comply with regulations.
Sure there are get-rich-quick schemes that have earned many a matchstick man a pretty penny. Lasting success, though? That’s earned on the basis of hard work and a solid reputation.
This concept makes regulations the building blocks to any kind of fruitful venture. The rungs in a ladder or the linchpin in a wheel, if you will. The metaphors are especially apt because, when it comes to manufacturing consumable goods, regulations become the guiding force to all aspects of production.
The Key to FDA 21 CFR Part 11 Compliance
If success is built on a solid reputation, then reputation is almost like currency. Waste enough goodwill by taking customers for granted, or worse, for a ride, and you run the risk of having nothing left. That’s why abiding by guidelines is crucial for both your customers and business prospects. The Food and Drug Administration’s (FDA) 21 Code of Federal Regulations (CFR) Part 11 serves as a prime example of the lengths to which one must go to ensure compliance.
The set of guidelines applies to food and beverage companies, drug makers, and medical-device manufacturers among others, all of which are overseen by the FDA. The standards call for the implementation of various controls with regard to the processing of electronic data.
Requirements for the following controls are included:
- Audit trails.
- System validations.
Furthermore, and perhaps most notably, the subject of electronic signatures is covered in great detail. As electronic signatures become more prevalent, their legal weight has grown. They are now recognized throughout most of the United States as being just as binding as handwritten ones, possessing even greater security.
In the Best Interest of Manufacturers
FDA 21 CFR Part 11 effectively smoothed any company’s transition to digital records and electronic signatures at the time of its introduction in the1990s by establishing international standards for each. Today, compliance keeps operational costs down and speeds up time to market, all by minimizing the risk of human error. Following set FDA standards is in the best interest of all parties involved, including the companies themselves who only stand to benefit.
The kinds of companies in question face a bevy of additional regulations. There are countless FDA guidances aimed at current Good Manufacturing Practices so pharmaceutical companies aren’t limited to respecting FDA 21 CFR Part 11.
For further proof, consider labeling and packaging, covered in 21 CFR Part 211. After all, even the smallest typos can have significant repercussions if dosage information is misprinted.
It all goes back to human error and how it must be mitigated, even if only to avoid costly recalls, with the well-being of consumers logically being an even higher priority. What should CEOs be more worried about? How much a recall costs or how much damage a lawsuit can do? The first leads to significant short-term losses. The second leads to irreparable harm to a company’s brand equity and integrity to the point that there may not be even be a long term.
The Real Building Blocks of Success
Systems do exist that both help eliminate the risk of human error and enable FDA 21 CFR Part 11 compliance. For example, the GlobalVision quality control platform, which digitally and efficiently proofs packaging components, has the required technical controls built into the software.
- The ability to sign electronically, as mentioned earlier.
- A hierarchy of access levels, including managers and administrators.
- Inspection profiles only admins or managers can create or edit.
- A Login Management module, requiring unique User ID and password combinations.
- A comprehensive Audit Trail, which logs events, tracing them back to specific users.
It’s critical to note software doesn’t ensure compliance. That is and always will be the responsibility of the manufacturer, but the right tools do make it simpler to get there. Just consider them building blocks in their own right, towards keeping compliant.
Regulatory affairs responsibilities take the primary form of oversight of a product’s life cycle. Through each of the product’s development stages, there are strict rules and guidelines to follow to ensure compliance.
by Ryan Szporer
A name on a dotted line may technically hold just as much legal weight as ever, but in the era of electronic signatures, a contract can be enforced without a pen ever touching paper.
by Ryan Szporer
Despite political hurdles and an economic recession, Brazil is forecasted to move up in the pharmaceutical world. The Latin American behemoth was ranked as the world’s 10th largest pharmaceutical market in 2011 and is predicted to take the fifth spot by 2021.
by Mike Malz