Development

Regulated Product Development

Product Development in a regulated environment is complicated and success requires effective collaboration.  One of the keys to getting your product to market on time and on budget is getting people working together efficiently without spending valuable time on non-value add activities.  Acera’s Product Development offering lets your team focus on the core design, science and engineering challenges without getting lost in the basics of document control and collaboration.  Acera’s most popular offering, Development gives your team the basics including:

• Project collaboration
  • Project Management of tasks, assignments and time lines
  • Issue Management and tracking
  • Meetings Management including design and phase reviews
• Device Definition
  • The ability easily define your Design History File (DHF) and Device Manufacturing Record (DMR)
  • Managing your Bills of Materials
  • Requirements and Specifications
  • Risk Management
  • Methods – Investigations, Labs, Tests, Protocols
  • Reports – Verification, Validation, Audits, Bench tests, Animal Studies
• Resources
  • External References
  • Supplier Management
  • Team Management
• Quality Management capabilities
  • Standard Operating Procedures
  • Work Instructions
  • Quality Manual
  • Communication Logs
  • Change Order Management

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