Our quality program is based on matching our customer's specifications with zero defects.

The most important aspect of our Clinical Label QA program is providing  labels that exactly match 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.
• Robust multigeneration QA system audited well over 100 times by biotech and pharma firms. 
• Security cages to cordon off materials discreetly labeled for confidentiality. 
• Rigorous line clearance procedures.
• 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.
• Clean partitioned rooms for controlled manufacturing.
• 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.
• 100% pagination inspection of each booklet label. 
• 100% bar code and missing label verification.
• Extreme sensitivity to anything that may create an unblind.
• Video surveillance of the entire facility for security. Keyfob entry to manufacturing.
• Active pest control program.
• Process for destroying excess/expired materials.
• Active training program.
• Climate controlled warehouse storage

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