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Quality Systems, Compliance and Engineering



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For pharmaceutical, medical device and OTC companies, AccuReg offers guidance and “hands on” support in the following critical compliance areas:
  • 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 Master Batch Records (MBRs), Device Master Records (DMRs), Device History Records (DHRs), Device History Files (DHFs), Standard Operating Procedures (SOPs), Standard Test Procedures (STPs)
  • Development and implementation of complaint handling systems
  • Development and implementation of Corrective and Preventive Action (CAPA) systems
  • Design control process development, implementation and training
  • Business process re-engineering (BPR)
  • Package design
  • Process automation and control
  • Process analysis/methods improvement
  • 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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