Our quality program is about exactly matching customer's specifications with zero defects.

The most important aspect of our Clinical Label QA program is providing a label that exactly matches our customer's specifications with zero defects. We have a deep commitment to our quality program because it is so important in clinical to make sure it’s exactly right. There are a lot of moving parts in clinical labeling so the only way to ensure that our labels are of the highest quality is to have a robust quality program that combines strong SOPs with computer verification.

We are constantly working on ways to make our quality better and more bullet-proof. Our SOP’s are routinely reviewed to make sure that they are fresh, relevant and lean. We use validated computer technology for inspecting labels, proofing text files and verifying that codes are printed properly against the customer supplied file. Where appropriate, manual checks are also conducted by our staff of highly trained and diligent professionals.

We have listed the “tools” below that we use on a routine basis that ensure we achieve excellent quality. The best tool is how we communicate with our customers. We want you to have absolute trust in what we provide so you will find us to "over-communicate" with you if there is such a thing. This includes timely calls to you for anything that we think you should review or need to be aware of.

Below is BCL's (19 years in development) Quality Program based on cGMP as defined by the FDA’s Code of Federal Regulations part 210 and 211.

Jeff Bertrand's 65 second comment on our Quality Systems.
 

 

 

• cGMP compliant.
• Software check of artwork preparation to ensure that the proof to be submitted matches customer supplied Word file. 
• Strong protocols for customer file handling.
• Validated Software for random variable code printing.
• Extreme sensitivity to anything that may create an unblind.
• 22 large security cages discreetly labeled for confidentiality. 
• Machine vision on label inspection equipment with specialized software oriented toward Booklet Labels.
• Computerized verification of customer approved proof against our printing proof.
• Computerized verification of the signed-off proof against a printed booklet sample.
• OCR verification of printed codes against customer supplied CSV or Excel files.
• Validated equipment.
• Quality pulls following a more pronounced ANSI standard.
• Production teams wear scrubs/head protection during manufacturing.
• Video surveillance of the entire facility for security.
• 100% bar code and missing label verification.
• Professional shredding contract to destroy excess materials. 
• Partitioned rooms for manufacturing control.
• Manufacturing in very clean conditions.
• Active pest control program.
• Rigorous Line Clearance procedures.
• Strict adherence to Quality SOPs.
• Active training program.
• Additional storage-locked and controlled.

We welcome audits and would enjoy having you inspect our facility. Please give Keith Schwertfeger a call at 716-631-9201 to setup your next audit.