Empowering employees and achieving compliance through a clear understanding and daily practice of compliance requirements. We can show you the way.

Regulatory compliance describes the goal that companies aspire to in their efforts to ensure that personnel are aware of and take steps to comply with relevant laws and regulations. In today’s world there are an increasing number of regulations and organizations are adopting the use of consolidated and harmonized sets of compliance controls. This approach is used to ensure that all necessary governance requirements can be met without the unnecessary duplication of effort and activity from resources.

Prism Plus Consulting has the experience to ensure compliance to regulatory requirements including establishment of procedures, audit of processes, review of reported metrics, employee training and management involvement. With fourteen years of experience with 21 CFR 13485 we have a focus on medical device manufacturing.

  • FDA Compliance:
    • Computer and software validation
    • FDA guidelines applicable to medical devices and drugs
    • Electronic signatures
  • Good Manufacturing Practice (GMP)
  • Procedures and Systems
  • Perform gap analysis of current process to regulatory requirements
  • Assist in the development of processes to meet regulatory requirements; FDA and ISO certifications
  • Design process for electronic signature compliance to Code of Federal Regulations 21 Part 11 Electronic Signature for medical devices
  • Quality Management System review or establishment
  • Review/establish Corrective and Preventive Action (CAPA) process
  • Establish internal audit requirements and schedule
  • Review or establish company policies, standard operating procedures, and associated work instructions
  • Software test scripts development
  • Software verifications / validations
  • Development of protocols and review of testing documentation
  • Prism Plus Consulting has training and certifications to perform activities associated with the following-
    • ISO: 9001 Process
    • ISO: 13485 Process
    • ISO: 13485 Lead Auditor
    • ITIL Foundation