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Quality Quarterly

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2nd Quarter 2008

Greeting Pic for Consulting Newsletter

Greetings!

Welcome to the official launch of Quality Quarterly, ABC's quarterly newsletter for FDA regulated industries.

Starting right now, you can look forward to, cost-effective solutions to common industry issues, clear explanations of regulatory requirements, and exclusive opportunities not offered to others.


Welcome, and I hope you find this edition of Quality Quarterly beneficial in your daily operations!



Inside the Tank

Information and Opportunities for Insiders Only 

Each quarter, this section of Quality Quarterly shares with you (our insiders) company details and offers that we do not share with the general public.

Who is ABC?

Since this is the first edition of Quality Quarterly, I would like to take this opportunity to briefly discuss with you who we are and how we operate our business.

Advanced Biomedical Consulting (ABC), LLC is a member of the ABC family of companies, a group of companies known for providing both cost-effective and extremely high quality products and services. ABC's services are specific to the needs of FDA regulated industries and are tailored to each client's specific operations. Therefore, our clients are assured that, whatever service we provide, the result is a sustainable solution after we leave.

ABC Logo

If you're considering ABC for your next project, you should know that we have quickly become known in the industry as the "hands-on" consultants. This stems from the fact that our services do not end with recommendations. ABC's resources are not only experienced and trained for the tasks they perform, but are also willing and able to quickly implement the recommendations offered. In addition, a trained and dedicated project manager is provided free of charge with each and every project (regardless of size or scope) to ensure the timeliness and quality of all deliverables. Therefore, you do not have to spend your valuable time managing the activities performed by our consultants.

Click here to learn more about our organization and its focus on cost-effective solutions to technical and regulatory aspects of our clients' operations.

Cut Costs and Get Help!

Today, ABC officially launched its new Cost Savings Programs.  We are announcing and offering these new opportunities to you, our insiders, first!  In addition to our reasonable rate structure (often times less than half that of our competitors), ABC is now offering several programs in order to stretch your consulting services budget.

Wanna learn how you can get help with your projects/workload and save money? Then, click on the following links to learn about each of our programs which are designed to get you and your organization the expert help needed while still maintaining the budget:


Unraveling the Regs

Interpreting Regulatory Requirements

Electrical Verifications in Equipment Qualification

The verification of electrical "specifications" during equipment qualification (EQ) and utility system qualification is often misunderstood by individuals involved in this validation related task. Electrical verifications are performed in two (2) test sections in the EQ protocol.
 

In the first test section, Major Component Installation Verification, the goal is to verify that the major components associated with the piece of equipment or utility system have been installed in accordance with manufacturer as well as internal Tape and Monitor Machine requirements/specifications. In this section, and from an electrical perspective, the specified voltage and frequency of each major component should be verified. This is accomplished by verifying the voltage and frequency specified in the protocol against physical settings on the component (e.g. dip switch settings) or from the component's nameplate.

 

In the second test section, Support Utility Verification, the goal is to verify that the support utilities installed to the system have been installed in accordance with manufacturer and internal requirements/specifications. In this section and from an electrical perspective, the following should be verified for each major component (as applicable):

  • Electrical Source (e.g. Panel Number)
  • Panel Fuse/Breaker Location and Rating
  • Actual Voltage (via Calibrated Multimeter or Reference Documentation)
  • Actual Frequency (via Calibrated Multimeter or Reference Documentation)
  • Labeling/Tagging (i.e. Identification of the above Verified Items)

Verifying electrical requirements during equipment qualification can be a confusing task as to what is required. So, should you be need further explanation, feel free to contact one (1) of our experts by clicking here for some free advice!


The Helping Hand

Compliance, Quality, and Operational Tips 

Size Matters!

Is the size of your quarantine area always an issue? When manufacturing and warehousing space is at a premium, designating a quarantine area can be difficult. Couple that with the fact that one (1) of the top observations by auditors is finding unapproved materials outside of spatially segregated areas, and you have a common, yet serious, issue with regards to quarantine areas.

Barrels So, how can you address this situation quickly and with little cost involved? Make that space portable and expandable! A great way to do this is through the use of portable stanchions. These relatively low-cost devices can be purchased or made in no time. First, purchase (or make) four (4) stanchions with adjustable lengths of ropes (or retractable belts) to cordon off a quarantine area (i.e. the area within the ropes). Then, hang signs around all four (4) sides specifying the area as "Quarantine". Now, you have a portable and adjustable quarantine area that meets the needs of your organization and meets the regulatory requirements of having a designated and spatially separated quarantine area for unapproved raw materials, components, and finished product.

For more quality, compliance, and operational tips, click here to contact us, and let us know what you we can help you with.

 

Thank you for reading this edition of Quality Quarterly!

Sincerely,  

Jennifer Guille
Manager, Business Operations
Advanced Biomedical Consulting (ABC), LLC

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