Pharmaceutical Compliance Best Practices (PH171)

Ensuring Quality Through Documentation, Training, and Auditing

  • Strengthen the Role of Compliance

    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.


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  • Pharmaceutical Compliance Metrics


    Chapter 1: Compliance Team Structure, Challenges, Budgets and Staffing

    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.
    • 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.


    Chapter Data

    41 charts focused on these topics:

    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)



    • 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)


    • 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 predictions 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 (2 Top 20, 1 Top 50, 3 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


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  • Pharmaceutical Compliance Report Excerpt


    The following excerpt is a key finding from the full report's executive summary:

    Leverage Online Training to Track Compliance Learning and Keep Employees Up-to-Date

    Data suggest that companies, especially small pharma, rely on an outmoded method of training. Distributing memos, measuring training in arbitrary terms and accepting shallow levels of noncompliance as a result of poorly prepared employees and processes is a recipe for repeated mistakes and lost revenue.

    As a rule, training should foster accountability, provide insight in to systemic issues, and give a company necessary procedural data lest an investigation or a compliance gaffe should occur. It is one of the most critical facets of compliance: a company cannot expect to be compliant with regulations if it has not properly trained its staff. Developing training programs is one of the costliest activities of any compliance team in terms of time, personnel and budget. Developing good training takes even more time; it requires sourcing various subject matter experts from within the compliance team and also from the function to which the standard applies. Having this as a mandate for compliance teams is appropriate, but it also requires organizational support. SOPs, processes and other control documents do not develop in a vacuum, but rather with the input and support of several functions.

    Figure E.1 [Figure included in Full Report] illustrates a dichotomy within the industry. Forty percent of surveyed compliance teams use the traditional hours per year metric to track and measure ongoing training, while another 40% prefer to track it through program completions.

    Other metrics such as hours per month or days per year trail at 7% and 13%, respectively.

    Hours per year is an outmoded training measure, and the fact that it still endures as a popular way to quantify training indicates a process improvement opportunity. The more efficient and more accountable way to quantify training is through training programs with discrete units, preferably completed online.

    Compliance groups find online training most efficient in terms of financial savings, time management, customizability, accountability and data analysis. Employees are able to complete the training when it is most convenient to their schedules, as long as the training is completed by a specified date. This method is an alternative to scheduling physical “classroom” sessions that have to be conducted multiple times to accommodate various individuals’ schedules. Not only is online training more convenient, but online videos and interactive digital platform as are more immersive for employees than traditional classroom sessions.

    Additionally, leveraging online technology allows the compliance group to easily track and monitor who has completed the necessary training and who has not. It is important to have a data trail of compliance trainings, so that if a compliance issue or investigation arises, companies can determine that the necessary compliance trainings were or were not completed. For large pharmaceutical companies with thousands of employees, a database or system to manage tracking of compliance training is especially essential.

    A critical feature of online training is that it offers the opportunity to test employees on whether they have learned the necessary compliance information. No training should be given unless there is a way to measure if the trainee has learned the intended SOP, policy change, new process, etc. These trainings should be mandatory and require employees to use an electronic signature to certify that they have completed the necessary trainings. Doing so gives companies the advantage of escalating the issue up to departmental management to make certain that the training is completed. It also introduces a measure of accountability to the process that puts the onus on the individual employee to make sure they are up-to-date with the current compliance environment.


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