To ensure safety, quality, and consistent product performance, it is essential to have quality systems in place that follow FDA & ISO requirements. For pharmaceutical, medical device, OTC, and Nutrition companies, ABR offers expert guidance and “hands on” support in the following critical compliance areas:

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• Quality Systems and compliance development and implementation (including comprehensive Master Plans for firms under consent decree and/or injunction)

• FDA 483 and Warning Letter responses and action plans

• Comprehensive documentation and record-keeping systems

• Development and review of individual compliance documents, including Corrective and Preventive Action Records (CAPA), Complaint Investigations, Master Batch Records (MBRs), Device Master Records (DMRs), Device History Records (DHRs), Device History Files (DHFs), Standard Operating Procedures (SOPs), and Standard Test Procedures (STPs)

• Development and implementation of complaint handling systems including coaching of site personnel

• Development and implementation of Corrective and Preventive Action (CAPA) systems including coaching of site personnel

• Design control process development, implementation, and training

• Method and process validations

• Software and computer systems validations

• Production equipment procurement

• Product equipment relocation

• IQ/OQ/PQ of equipment and systems

• Development and implementation of Validation Master Plans and validation SOPs

• QS Regulation, GMP, GLP, and GCP training programs for personnel at all levels

• Internal Audit and clinical audit training

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Corrective and Preventive Action (CAPA) Services 

The CAPA system is a known gateway for regulatory observations. ABR has worked with many organizations to develop sustainable CAPA processes that achieve improvements both in implementation of robust corrective actions and reduced compliance risk. ABR’s broad range of CAPA support services include implementation of governance processes and coaching of all personnel in the identification, evaluation, investigation, action planning, and effectiveness check activities associated with CAPA records. 

 

Our top priority in any CAPA project is to drive improvements in critical thinking and technical writing across the organization - skills that can be used going forward in all elements of the quality system. We have executed multiple CAPA Remediation projects that include implementation of new processes and coaching of staff at all levels. Our ultimate goal is to ensure that new processes are implemented effectively AND sustained across the organization after we complete the project.