Process System Validations
Process System Validations are critical to quality and safety in industries where consistency, precision, and regulatory compliance are paramount. Validations help minimize the risk of product defects, contamination, and safety issues, ultimately ensuring the production of high-quality and safe products. They are critical for FDA compliance, and as FDA “preventative controls qualified individuals,” we’re here to help.
Analytical Method Validation
With our decades of experience, we can assist you in developing and/or executing validation and system qualification protocols to establish that your analytical methodologies and equipment are equal or superior to the USP/NF compendia methods.
Automated Plant Validation
B&R has hands-on experience in developing and executing FDA-compliant validation protocols for automated plants that produce medical products. We have successfully validated major Air Separation and Helium facilities, as well as Carbon Dioxide facilities that manufacture medical-grade gases. B&R’s principles directed the current approach to ASU validation used by the majority of the industry today.
We have assisted firms with designing and executing programs and procedures to validate their cleaning processes related to gases. With B&R’s practical and focused approach to validation, they successfully achieved their goals without breaking the bank.
Manufacturing and analytical equipment that are computer-controlled or operated are required by FDA to be validated. B&R Compliance Associates has the experience and expertise to develop and execute a validation that is both FDA-compliant and cost-effective.
Cylinder Fill Validation (Manual and Automated)
With B&R, you can easily validate your high-pressure and cryogenic liquid filling systems to meet current FDA requirements. Our validation protocol templates can easily and cost-effectively adapt to your business and compliance needs.
Are you contemplating purchasing or in the process of installing a new fill system? We can provide guidance on what documentation you need from the system manufacturer to facilitate your system validation.
Electronic Recordkeeping and Signature System Validation
Today, firms have or are moving towards maintaining production records electronically, as well as capturing signatures of individuals electronically. Using these systems to maintain FDA records requires that you appropriately validate the system, per 21 CFR Part 11. B&R has experience in validating recordkeeping systems commonly used in the Medical Gases industry. We have the expertise to guide you through this process as painlessly as possible.