Prima, Published

Posted on 27. May, 2009 by in Documentation & Training, Prima Communications Blog

Larry Elwell, Prima’s Director of Engineering Services, recently authored an article published in Medical Device & Diagnostic Industry magazine’s May 2009 issue. Larry’s article focuses on the documentation piece of quality system compliance and explains how well-developed documentation can be an asset during audits as well as for daily operations use.

Having been through a few audits myself, I can second Larry’s advice on how dedicating energy in document development can pay off during audits or certification evaluations. While your staff may be the experts on the information, having a professional writer assist in document development will not only ensure your documents are developed consistently and concisely, but with the years of experience our staff brings with us, will often enable us to lend additional insight and value.

Larry (or any of our other qualified, talented professionals) is available to discuss your unique documentation needs, audit plans, or how this year’s ISO requirements compare to last year’s.

Are Your Documents Useful?

Posted on 22. Apr, 2009 by in Documentation & Training, Prima Communications Blog

Let’s face it—most of us write documents for the wrong reasons.

Either a) someone told us to write it, b) there’s a regulation that says we need it, or c) something went wrong or was done incorrectly, so it was decided that a document should be created or modified to “fix” that problem.

Why are these reasons wrong, you ask? Because ideally, a document—a work instruction, a procedure, a manual, or yes, even a policy—should be written to inform and instruct. It should be written for the user, the reader, the operator—rather than the boss who said it needed to be written—or the FDA.

Writing for a wrong reason inevitably creates unwieldy, complicated, and redundant documents that are not useful. And the more convoluted the information, the more difficult it is to maintain that document set.

It’s a challenge to go back and undo what’s already in place. Most of us have inherited these cumbersome document sets, and reversing the trend of complex, often unnecessary documentation is not an easy task. But there is hope.

You can start by following these three simple steps:

  1. Write with the audience in mind—NOT the auditor. Not your boss.
  2. Say what needs to be said—nothing more, nothing less. This can be very difficult and ties directly to the first point. Too often we err on the side of including everything, but that is faulty in several respects.
  3. Use pictures or visuals.

You can’t easily change what’s already in place—though sometimes the effort required to do so is well worth it—but you can try to move the trend in the right direction.

Obama May Make FDA Appointments Soon

Posted on 12. Mar, 2009 by in Prima Communications Blog

It looks as though President Obama is likely to choose Peggy Hamburg as FDA commissioner and Joshua Sharfstein as a deputy commissioner. Hamburg is a former New York City health commissioner, and Sharfstein is Baltimore’s health chief.

It will be interesting to see how Congress reacts to these appointments (if they are indeed made), and how new leadership at the FDA will affect public policy and the ways pharmaceutical companies (and the vendors that support them) conduct research and do business.

Could Your Quality System Be Better?

Posted on 09. Mar, 2009 by in Documentation & Training, Prima Communications Blog

Does your company have a quality system? The odds are it does even if you call it something else. Because of requirements from ISO, FDA, and other certifying bodies, virtually every company has some sort of quality system. But does your company really use its quality system, or is it simply going through the motions?

I have found that most companies don’t fully embrace and leverage their quality systems. A good quality system should help the company function more efficiently. The procedures included in the system should be clear and concise, and should help personnel do their jobs more effectively. The quality system should also drive continuous improvement and product quality, and should not take a lot of resources to maintain.

If your quality system does not help make your products or services better, you are missing a great opportunity to save money and increase employee empowerment. Review your company’s quality system and see if it’s really helping the bottom line or just earning you a check mark on someone’s audit list.

We’re making a product that is governed by the FDA. What’s your experience with what they need?

Posted on 09. Jan, 2009 by in FAQs, Prima Communications Blog

Prima has been working in FDA-regulated environments for nearly two decades. While the terminology related to validation of equipment and processes has changed over the years, the underlying reasons have not. Whether it is validation, commissioning, qualification, or some other related requirement, we’ve done it.

Our experience runs the gamut of working with the largest pharmaceutical companies in the world to supporting small, early-stage companies. Our roles have ranged from strictly producing the necessary documents to documenting and assisting in protocol execution. For tasks that require engineering, we partner with established engineering companies to get the job done.

Of course, meeting FDA requirements is not limited to validation efforts. Procedures, work instructions, and other related documentation—along with document control systems—are also needed. Again, Prima has the experience.

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