Benchmarking and Quality Best Practices
Best Practices, LLC has conducted extensive research in the field of Benchmarking and Quality. Browse through and sample our published Benchmarking and Quality research in the topics below:
| |  | Quality Metrics and Compliance Research Bundle  
Non-Members: Download a complimentary study summary of the Quality Metrics and Compliance Research Bundle at http://www3.best-in-class.com/de171.htm. The summary contains sample graphs and research findings from the separate research initiatives included in the bundle as well as an overview of Best Practices, LLC's Database service offering.
In light of increased FDA scrutiny, Quality and Compliance among pharmaceutical and healthcare companies have become an increased area of focus. Poor quality and compliance can lead to heavy fines, lost credibility, or even closed operations and organizations. In order to stay on top, it is essential that pharmaceutical and healthcare companies use the best and most efficient tactics when organizing and maintaining Quality and Compliance Programs.
The Quality Metrics Research Bundle presents a comprehensive look at the structure of manufacturing quality efforts at more than 25 pharmaceutical, healthcare and medical device companies. It includes survey and interview results from several of Best Practices, LLC's research initiatives.
This comprehensive Research Bundle contains benchmarks in the following areas: staffing, procedures, workflow, and productivity aspects of quality assurance/quality control laboratories. Specific metrics in this bundle include conversion costs, capacity utilization, quality control efficiency, staffing levels by function and management responsibilities, and levels of automation. In addition, the Quality Metrics Research Bundle includes research on how best-in-class companies restructured for improved quality and reduced costs, with specific emphasis on shared service implementations and the decision to outsource or off-shore operations.
Sample key findings from the research initiatives featured in this bundle include:
One study showed that most companies in the benchmark class have completed a major reorganization within the past three years. All of those that have not already reorganized plan to do so within the next three years.
Another study revelaed that most partners reported only average degrees of automation in their facilities. One company with a high degree of automation reported considerably better maintenance cost, headcount, and overtime performance when compared to other benchmark partners.
An effective way to drive continuous performance improvement is to tie key productivity and quality indicators to employee compensation. Benchmark surveys and best practice interviews reveal that most quality control laboratories already track a variety of productivity and quality indicators, including an assays done right first time yield (ADRFT), testing cycle times, analyst/chemist productivity and rework. However, only a few labs directly tie performance measures to employee compensation.
The information in this document is essential to any pharmaceutical or healthcare company looking to improve or maintain a successful quality and compliance program. The Quality Metrics Research Bundle is offered at significant cost savings and is a great way to begin evaluating and restructuring your own Quality and Compliance program.
Regulatory Affairs Excellence: Structure and Roles in Medical Device Companies
Non-members: Click here to review a complimentary excerpt from "Regulatory Affairs Excellence: Structure and Roles in Medical Device Companies"
STUDY OVERVIEW
Regulatory Affairs groups ensure that medical device companies comply with global regulations pertaining to developing and marketing medical device products. The effectiveness of a Regulatory Affairs group is, in part, tied to how well its responsibilities are delineated and the group itself is structured.
Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure and roles of Regulatory Affairs groups at medical device companies.
This study presents benchmarks around organizational structure to provide insights around reporting lines and span of control. In terms of the role of Regulatory Affairs, the research study presents data showing the role (lead, support or no role) of regulatory, regulatory compliance and quality across 10 key responsibilities. There are also benchmarks around publishing and translation roles and the impact of 510(k) reform on regulatory resources Additionally, there are qualitative insights on these issues from regulatory leaders in the device sector.
Medical device regulatory leaders can use this study to compare their group structure and roles with those of leading medical device companies.
KEY TOPICS
Executive Summary
Participant Background
Regulatory Affairs Structure
Regulatory Function Roles and Responsibilities
Impact of 510(k) Reform
SAMPLE KEY METRICS
How is your Regulatory Affairs group structured
Into which level does your Regulatory Affairs function report
Average number of direct reports for Regulatory leaders at these five levels
Does Regulatory Affairs lead, support or play no role for the following (10) responsibilities
Does Quality lead, support or play no role for the following (10) responsibilities
Does Regulatory Compliance lead, support or play no role for the following (10) responsibilities
List the primary responsibilities of your corporate Regulatory Affairs group
Who handles publishing of regulatory documents
How do you think new 510(k) reforms will affect your regulatory resources
SAMPLE KEY FINDINGS
Publishing, Translations & Storage Solutions: Publishing regulatory documents stay in-house, whether done through a dedicated team or general regulatory resources. Translations are outsourced to third party vendors for most of the benchmark class. A global IT solution handles the storage of regulatory documents.
Concerns about Increased Scrutiny & Reform: Increased regulatory scrutiny is the main concern for Regulatory Affairs executives in the next three years. Additionally, half of respondents feel uncertain about the impact of 510(k) reform on Regulatory Affairs resources.
METHODOLOGY
For this benchmarking study, Best Practices®, LLC gathered insights and performance data from eight regulatory leaders representing eight leading medical device organizations. In addition, executive interviews were conducted with selected participants to produce qualitative insights.
Regulatory Affairs Excellence: Resource Benchmarks and Staffing Trends for Medical Device Companies
Non-members: Click here to review a complimentary excerpt from "Regulatory Affairs Excellence: Resource Benchmarks and Staffing Trends for Medical Device Companies"
STUDY OVERVIEW
Regulatory Affairs groups help guide their organizations through the regulatory labyrinth that companies must navigate as part of developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies to remain productive. Optimal resourcing and staffing help Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth.
Best Practices, LLC conducted this benchmarking study to establish metrics around Regulatory Affairs' budget and FTEs for medical device companies. In addition, this study gleans insights from regulatory leaders at device organizations regarding anticipated future resource trends in Regulatory Affairs.
This study presents spend, FTE and consultant benchmarks for the medical device industry. Specifically, the research includes spend, FTE and consultant ratios, such as regulatory spend per FTE, FTEs per $100M in revenue, and consultants per $100M in revenue. In addition, the study contains quantitative benchmarks and qualitative insights around anticipated Regulatory Affairs staffing trends in the medical device sector, including the use of outsourcing and offshoring.
Medical device regulatory leaders can use this study to compare their spend, FTE and consultant ratios and benchmarks with those of leading medical device companies.
KEY TOPICS
Executive Summary
Participant Background
Regulatory Function Investment and Staffing
Regulatory Function Outsourcing and Offshoring Trends
SAMPLE KEY METRICS
How many regulatory FTEs are in Corporate Regulatory Affairs
Estimate the number of in-house FTEs and Consultants for Regulatory Affairs in 2010
How has Regulatory Affairs spend changed in past three years
How has overall Regulatory Affairs headcount changed in past three years
In the next three years, how do you expect Regulatory Affairs staffing to change
In the next three years, do you expect Regulatory Affairs to grow its internal or external resources
Percentage of Regulatory Affairs spend allocated for outsourcing
Responsibilities outsourced by Regulatory Affairs
Over next three years, do you expect outsourcing levels to grow, shrink or stay the same
Percentage of regulatory spend allocated to offshoring
SAMPLE KEY FINDINGS
Regulatory Affairs 2010 Staffing: Regulatory Affairs staffing averages 2.3 FTEs per $100M in medical device revenue. Headcount has remained the same for half of the benchmark class during the past three years as pressures to cut costs are mounting.
Outsourcing Levels: Regulatory leaders don’t expect outsourcing levels to grow in the next three years – in fact a third believe they will shrink.
METHODOLOGY
For this benchmarking study, Best Practices®, LLC gathered insights and performance data from eight regulatory leaders representing eight leading medical device organizations. In addition, executive interviews were conducted with selected participants to produce qualitative insights.
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