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Pharmaceutical Compliance Best Practices: Ensuring Quality Through Documentation, Training, and Auditing

Abstract

Each year, regulatory non-compliance costs the life sciences industry billions of dollars in fines, recalls, audits and more. To avoid these missteps, companies rely heavily on experienced compliance teams, which provide oversight from the earliest R&D to the very end of the product lifecycle.

Compliance teams do critically important work across a wide range of functions, but they face a raft of challenges. Simply keeping pace with the dizzying, ever-growing array of national and international standards is difficult enough, but groups also face obstacles in securing needed resources, building internal buy-in, strengthening training programs and more.

This report provides detailed benchmark data and case studies for teams seeking to improve their organizations' approaches to compliance. With metrics on budgets, staffing and support, as well as specific challenges, the findings provide a guide for compliance teams across all company types and sizes.

Strengthen the Role of Compliance within Your Organization

Team structure is critical to success. Use the report's team profiles to build effective, empowered compliance groups. Understand internal alignment models, leadership, staffing levels and outsourcing.

Create, Train, and Monitor Compliance Effectively

Striking the balance between over- and under-compliance is an art and a science. Leverage digital training to keep employees up-to-date with the latest policies and regulations, enforce employee accountability and escalate problems via proper channels. Explore training metrics to spot recurring trouble spots, improve processes and avoid costly compliance issues.

Manage a Growing List of Global Standards and Regulations

Compliance teams juggle a staggering number of laws, regulations and guidelines in markets around the globe, which means increased - and increasingly complicated - workloads. Implement best practices and successful processes to meet the internal and external challenges of this reality head on.

Table of Contents

  • 9 Executive Summary
  • 11 Study Methodology
  • 12 Study Definitions
  • 13 Profiled Companies and Therapeutic Areas
  • 13 Three Key Recommendations
  • 19 Structure and Challenges; Budgets and Staffing of Compliance Teams
  • 20 Structure: Align Compliance with Internal Expertise
  • 38 Time and Budget Largely Spent on Audits, Training and Documentation
  • 48 Compliance Training Processes and Metrics
  • 58 Compliance Team Budgets and Staffing
  • 67 Compliance Challenges: Internal versus External
  • 75 Compliance Team Profiles
  • 76 Company I Compliance Team Profile
  • 82 Company J Compliance Team Profile
  • 87 Company O Compliance Team Profile
  • 92 Company F Compliance Team Profile
  • 97 Company C Profile
  • 103 Company R Profile
  • 108 Company K Profile
  • 113 Company M Profile

KEY METRICS

Chapter 1: Structure, Activities, Budgets & Staffing, and Challenges

Chapter Benefits

  • Centralize compliance oversight behind at least one high-level individual, such as a chief compliance officer.
  • Empower specialists to do ground-level compliance work within different departments.
  • Benchmark budget and time spent across key compliance activities.
  • Find the right balance between over- and under-compliance.
  • Examine staffing over a 6-year span with year-over-year metrics and projections for the future.
  • Implement processes to stay on top of changing regulations across the globe.
  • Manage critical internal and external challenges for all compliance groups.
  • Leverage digital training to increase employee understanding and minimize issues.
  • Explore a case study of one company using compliance as a strategic means to ease entry into emerging markets.

Key Metrics

  • 41 charts focused on structure, resources, training and more:

Structure and Responsibilities

  • Structure of compliance function for all companies (broken down by company type: Top 20, Top 50, medical device and small/biotech)
  • Percentage of budget and time spent on specific compliance activities (by company type)
  • Frequency of contact with regulatory agencies
  • Functions within compliance teams' jurisdiction (by company type)
  • Leadership of compliance teams
  • Average age of compliance teams (by company type)

Training

  • Percentage of compliance teams that conduct internal training, new hire training, and external personnel training
  • Frequency of internal compliance training
  • Reasons for ad hoc internal compliance training
  • Units (hours, days, etc) used to measure compliance training (by company type)

Budgets

  • Compliance budgets for 2010-2012 (by company type)
  • Sources of compliance budgets

Staffing and Outsourcing

  • In-house and outsourced compliance FTEs
  • Staffing trends from 2010-2012
  • Three-year projections of staffing trends for 2013-2015
  • Average in-house and outsourced FTEs per compliance team (by company type)

Challenges and Performance

  • Ratings of external compliance challenges
  • Ratings of internal compliance challenges (by company type)
  • Ratings of internal departmental compliance

Chapter 2: Compliance Team Profiles

Chapter Benefits

  • Find tailored benchmarks with 8 in-depth case studies across different company sizes:
  • 6 pharma teams (two Top 20, one Top 50, three small/biotech)
  • 2 device teams
  • Draw connections between individual teams' structures, resources, staffing and challenges.
  • Delve into spending-per-activity and time-per-activity data to streamline workflow and compare team performance.
  • Understand different companies' approaches to compliance structure.
  • Identify different compliance teams' most pressing challenges.

Key Metrics

  • 32 charts across 8 separate company profiles:
  • Team structure, leadership and internal reporting line
  • Team budget and staffing data
  • Percentage change in team headcount and budget, 2010-2012
  • Percentage of time and budget allocated to specific compliance activities
  • Ratings of internal and external challenges facing team

CHARTS AND GRAPHICS

Executive Summary

  • Three Key Recommendations
  • 15 Figure E.1: All Companies: Internal Compliance Units

Structure and Challenges; Budgets and Staffing of Compliance Teams

  • Structure: Align Compliance with Internal Expertise
  • 21 Figure 1.1: Structure of Compliance Function: All Companies
  • 22 Figure 1.2: Structure of Compliance Function: Top 20 Companies
  • 23 Figure 1.3: Structure of Compliance Function: Top 50 Companies
  • 24 Figure 1.4: Structure of Compliance Function: Small/Biotech Companies
  • 24 Figure 1.5: Structure of Compliance Function: Device Companies
  • 28 Figure 1.6: Frequency of Contact with Regulatory Agencies
  • 30 Figure 1.7: Compliance Team Oversight: All Companies
  • 31 Figure 1.8: Compliance Team Oversight: Top 20 Companies
  • 32 Figure 1.9: Compliance Team Oversight: Top 50 Companies
  • 33 Figure 1.10: Compliance Team Oversight: Small/Biotech Companies
  • 34 Figure 1.11: Compliance Team Oversight: Device Companies
  • 35 Figure 1.12: Level of Executive Leading Compliance: All Companies
  • 36 Figure 1.13: Level of Executive Leading Compliance, by Structure
  • 37 Figure 1.14: Average Age of Compliance Teams, by Company Type
  • Time and Budget Largely Spent on Audits, Training and Documentation
  • 42 Figure 1.15: Percentage of Budget and Time Spent, by Compliance Activity: All Companies
  • 44 Figure 1.16: Percentage of Budget and Time Spent by Compliance Activity: Top 20 Companies
  • 45 Figure 1.17: Percentage of Budget and Time Spent, by Compliance Activity: Top 50 Companies
  • 46 Figure 1.18: Percentage of Budget and Time Spent, by Compliance Activity: Small/Biotech Companies
  • 47 Figure 1.19: Percentage of Budget and Time Spent, by Compliance Activity: Device Companies
  • Compliance Training Processes and Metrics
  • 49 Figure 1.20: Percentage of Compliance Teams that Conduct Internal Training
  • 50 Figure 1.21: Frequency of Internal Compliance Training
  • 51 Figure 1.22: Reasons for Ad Hoc Internal Compliance Training
  • 52 Figure 1.23: Internal Compliance Training Units: All Companies
  • 54 Figure 1.24: Internal Compliance Training Metrics:Top 20 and50 Companies
  • 55 Figure 1.25: Internal Compliance Training Metrics: Small/Biotech and Device Companies
  • 56 Figure 1.26: Percentage of Compliance Teams that Conduct New Hire Training
  • 57 Figure 1.27: Percentage of Compliance Teams that Conduct External Personnel Training
  • Compliance Team Budgets and Staffing
  • 59 Figure 1.28: Compliance Budgets for 2010 - 2012, by Company Type
  • 60 Figure 1.29 Compliance Budget Source: All Companies
  • 62 Figure 1.30: Average In-House and Outsourced FTEs per Compliance Team, by Company Type
  • 63 Figure 1.31: In-House and Outsourced Compliance FTEs for Companies that Outsource
  • 64 Figure 1.32: Average Percentage of Outsourced Compliance FTEs: All Companies that Outsource
  • 65 Figure 1.33: Staffing Trends from 2010 - 2012: All Companies
  • 66 Figure 1.34: Three-year Predictions of Staffing Trends: All Companies
  • 67 Figure 1.35: Ratings of External Compliance Challenges: All Companies
  • Compliance Challenges: Internal versus External
  • 69 Figure 1.36: Ratings of Internal Challenges: All Companies
  • 70 Figure 1.37: Ratings of Internal Challenges: Top 20 Companies
  • 71 Figure 1.38: Ratings of Internal Challenges: Top 50 Companies
  • 71 Figure 1.39: Ratings of Internal Challenges: Small/Biotech Companies
  • 72 Figure 1.40: Ratings of Internal Challenges: Device Companies
  • 73 Figure 1.41: Ratings of Departmental Compliance: All Companies

Compliance Team Profiles

  • Company I Compliance Team Profile
  • 78 Figure 2.1: Background and Structure: Company I
  • 79 Figure 2.2: Compliance Team Resources: Company I
  • 80 Figure 2.3: Compliance Team Activities: Company I
  • 81 Figure 2.4: Ratings of Challenges: Company I
  • Company J Compliance Team Profile
  • 83 Figure 2.5: Background and Structure for Company J
  • 84 Figure 2.6: Compliance Team Resources: Company J
  • 85 Figure 2.7: Compliance Team Activities: Company J
  • 86 Figure 2.8: Ratings of Challenges: Company J
  • Company O Compliance Team Profile
  • 88 Figure 2.9: Background and Structure for Company O
  • 89 Figure 2.10: Compliance Team Resources: Company O
  • 90 Figure 2.11: Compliance Team Activities: Company O
  • 91 Figure 2.12: Ratings of Challenges: Company O
  • Company F Compliance Team Profile
  • 93 Figure 2.13: Background and Structure: Company F
  • 94 Figure 2.14: Compliance Team Resources: Company F
  • 95 Figure 2.15: Compliance Team Activities: Company F
  • 96 Figure 2.16: Ratings of Challenges: Company F
  • Company C Profile
  • 99 Figure 2.17: Background and Structure: Company C
  • 100 Figure 2.18: Compliance Team Resources: Company C
  • 101 Figure 2.19: Compliance Team Activities: Company C
  • 102 Figure 2.20: Ratings of Challenges: Company C
  • Company R Profile
  • 104 Figure 2.21: Background and Structure: Company R
  • 105 Figure 2.22: Compliance Team Resources: Company R
  • 106 Figure 2.23: Compliance Team Activities: Company R
  • 107 Figure 2.24: Ratings of Challenges: Company R
  • Company K Profile
  • 109 Figure 2.25: Background and Structure: Company K
  • 110 Figure 2.26: Compliance Team Resources: Company K
  • 111 Figure 2.27: Compliance Team Activities: Company K
  • 112 Figure 2.28: Ratings of Challenges: Company K
  • Company M Profile
  • 114 Figure 2.29: Background and Structure: Company M
  • 115 Figure 2.30: Compliance Team Resources: Company M
  • 116 Figure 2.31: Compliance Team Activities: Company M
  • 117 Figure 2.32: Ratings of Challenges: Company M
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