B&D is an authority in ensuring compliant systems and facilities. B&D validation engineers understand the rules and regulations and can deliver turnkey validation services faster and more cost effectively than any competitor in the industry.
Increased reliance on computer systems during regulatory inspections is a consistent trend in the pharmaceutical and healthcare industries. More stringent standards, e.g., Regulation 21CFR-Part 11, and an increased awareness of computer compliance and validation issues among inspectors have created new challenges within the pharmaceutical industry.
B&D helps clients avoid costly retrospective validations through the timely application of GAMP 4 methodologies. In addition, B&D assists clients in the understanding of regulatory requirements as they relate to their specific situations.
B&D's Validation Services include:
Project Planning and Scheduling
Development and Implementation of Quality Management Systems
Internal and External Audits
Validation and cGMP Training
Preparation for FDA and Other Regulatory Inspections
Start-up and Commissioning
Process and Cleaning Validation
Vendor Acceptance Testing
Validation Master Plans
IQ/OQ/PQ Protocols and Summary Reports
Standard Operating Procedures
Factory and Site Acceptance Testing (FAT/SAT)
Computer/Automation Test Plans and Scripts
User and Functional Requirements/Specifications
cGMP Support Services
Facility/Systems Design review
Continuous Monitoring Program Development