Sunday, April 21, 2019

Strategic Consulting

Other Compliance Services  /  Strategic Consulting

Strategic Consulting for Compliance
& Quality Assurance

Ensuring quality and regulatory compliance isn’t all about audits; sometimes you just need some advice. Maybe you're new to pharma research or manufacturing and need help determining what to focus on first. Or maybe you're an industry veteran looking for feedback on a Part 11 gap analysis or computer systems risk assessment. And maybe you need something in between.

Our team can act as an extension of your own by providing the strategic consulting and technical advice you need. Here are some of the ways we’ve been able to help our clients.

GCP / GLP/ CGMP

GxP Consulting

  • Performing gap analyses against regulations
  • Serving as advisors for Project Managers and QA Managers
  • Training staff in regulatory requirements and research techniques
  • Conducting process flow assessments for CGMPs
  • Developing clinical trial materials labeling
  • Conducting due diligence of manufacturing operations and processing systems
  • Serving as liaison among contractors (API manufacturers, laboratories, manufacturing, and distribution centers)
  • Providing a “man in the plant” for manufacturing support
  • Assisting start-up companies with ramp-up activities related to manufacturing and quality assurance, including development of internal staff and/or outsourcing
  • Developing regulatory strategies and strategic plans for interactions with the FDA
  • Writing CMC portions of INDs and NDAs
  • Assisting personnel at new clinical sites in establishing efficient operations

Computer Systems

Computer Systems Consulting

  • Orient companies new to the regulated industry about validation, Part 11, and data integrity obligations
  • Mentor your staff on how to take computer system projects and processes forward
  • Conduct gap analyses of your systems against regulatory requirements (e.g., Part 11), and advise you on what to address first
  • Serve as a “sounding board” for adhoc compliance questions within your organization
  • Develop practical, customized, and appropriate approaches to your computer system validation (CSV) efforts and documentation
  • Review/revise your vendor qualification SOPs
  • Bridge the gap between IT, business units, QA, and vendors by addressing expectations and responsibilities
  • Coach your staff on CSV concepts and Part 11 regulations as you execute your own validation project
  • Assess risks to data integrity as your data flow through your systems
  • Write validation plans and summary reports for your systems
  • Identify system relevance, system and vendor risk, and interpret audit findings
  • Provide validation document templates to make your processes efficient and repeatable
  • Work with your business units to define and document requirements for new computer systems

Do you need something you don’t see listed above? Give us a call.

     
   
     
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We conduct compliance audits
and save time to market for
our customers worldwide.
How can we help you?

Polaris Compliance Consultants, Inc.
1151 Executive Circle Suite 202

Cary, NC 27511-4589
(919) 463-0003

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