Blue Harbors Offers a Wide Array of Compliance, Validation and Advisory Services
Audit Services – We perform all types GMP and GLP Audits and provide a very detailed, specific report of recommended actions, including full references to the pertinent regulations and guidance documents. We also help our clients in CSV Audits and DMF services.
Compliance Issue Resolution – We have helped organizations facing compliance problems with FDA. We have earned a solid reputation for delivering high-quality insight and recommendations to resolve those challenges.
Quality Systems – We will create, review, implement or improve any Quality Systems, including all those for QA, Manufacturing, Laboratories, and support groups.
Computer System Validation – We can write the SOPs, Master Plans, and protocols required to make sure your systems are fully validated and compliant with 21 CFR Part 11 Electronic Records, Electronic Signatures.
Equipment Qualification – We will write the qualification protocols on all major pharmaceutical equipment or review your current program to ensure it is current and compliant
Process Validation – We will set up a process validation program that will pass inspector scrutiny, everything from writing the SOPs and Master Plans to writing and executing the protocols and summarizing the data into usable reports.