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.

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:

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 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):

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.

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.