Tag Archives: FDA

14Jan/19
Jumping

White Paper: Stop Managing Paper in a Data-Driven World

How Electronic Batch Records (EBR) Can Support Quality Metrics

By: Sandra K. Rodriguez, Market Analyst

Many life science companies have implemented manufacturing information systems as part of their automated manufacturing initiatives aimed at increasing product quality and lowering manufacturing costs. For many emerging and mid-market companies, however, paper batch records and a hyper-focus on compliance remain a reality. The result is a reliance on paper-based processes in a data-driven world.

Companies that have made the shift from paper to data-driven intelligence are aspiring to gain visibility by unlocking valuable manufacturing data to support quality metrics, as well as initiatives such as lean manufacturing, quality by design and continuous improvement. Companies that do not have access to this level of visibility should consider investing in the appropriate quality systems now. Regardless of their size, companies seeking to implement innovative electronic batch record (EBR) and quality management systems (QMS) now have a choice: either on premise or in the cloud.

Today the FDA intends to drive life science companies to harness data from manufacturing and quality systems and turn that data into intelligence. The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) provides the FDA with the authority to conduct electronic inspections (e-Inspections) and target onsite inspections based on quality metrics.

Register to receive your complimentary copy of this White Paper.  We discuss:

  • Why Shift from Paper
  • FDA’s Request for Quality Metrics
  • Why Compliance and Quality Are Not the Same
  • The Role of Executive Leadership

This white paper was written by Axendia, Inc. and sponsored by MasterControl Inc.

 

26Nov/18
quality

FDA’s Medical Device Enforcement and Quality Report

FDA Issues a Report on Increased Medical Device Inspections and Improved Compliance

The Report highlights:

  • Annual device inspections have increased 46% since 2007
  • The annual number of foreign device inspections have increased 243%  since 2007
  • The Agency is taking a targeted, risk-based enforcement approach to address specific device areas of concern.  Case studies mentioned in the report are:
    • Infusion Pumps
    • Automated External Defibrillators
    • Radiation Therapy Devices
  • From 2008 to 2007, 82% of firms corrected observed violations on follow-up inspections.
  • The FDA is also continuing to promote device quality through the Case for Quality initiative.

For related reading based on our involvement with the Case for Quality, please see:

FDA Driving Industry “Beyond Compliance” to Promote Manufacturing Quality

Is Compliance an Obstacle to Quality?

What is FDA Thinking? We Asked, They Answered!

The Case for Quality Voluntary Pilot Program

 Quality Metrics Program Update

13Sep/18
Brain - small - low res

Survey: Modeling and Simulation in Life-Sciences

Tina Morrison, PhD, Deputy Director, Division of Applied Mechanics and Chair of FDA’s Modeling and Simulation Working Group recently presented initiatives underway at the agency to advance the use of Modeling and Simulation.
FDA routinely advises industry on using modeling and simulation to, for example:
  • Predict clinical outcomes
  • Inform clinical trial designs
  • Support evidence of effectiveness
  • Identify the most relevant patients to study
  • Predict product safety
Axendia would appreciate your input on a survey that focuses on the current use and perceived value of Modeling and Simulation in Life-Sciences.

The survey should take no longer than 10 minutes to complete and all individual responses will be kept strictly confidential.  You are also welcome to register to receive a copy of the survey outcome.
06Sep/18
68530 Connected Doctor

The Value of Analytics in Value-Based Healthcare

Perspectives from Key Stakeholders in the Healthcare Ecosystem

By: Daniel R. Matlis, President

The primary drivers for Healthcare today are improving the quality of patient outcomes, enhancing patient-centered care and adopting initiatives that control costs while maximizing patient benefit.

Healthcare ecosystem stakeholders, including physicians, clinicians and supply chain professionals utilize data to make value-based procurement decisions for medical devices to ensure and improve patient access to high quality devices.  The integrity of these decisions depends upon the accuracy and completeness of unbiased analysis of underlying data to support patient care decisions.

To gain insights from key stakeholders on the use of analytics to support the transition to value based healthcare, Axendia interviewed a group of thought-leaders representing the Medical Device Innovation Consortium (MDIC) Case for Quality Product Quality Outcomes Analytics (PQOA) working group.

Each stakeholder offered their unique perspective on the value proposition for the PQOA Dashboard.

These thought-leaders are (in alphabetical order):

Stephanie Christopher – Program Director at Medical Device Innovation Consortium (MDIC).

Garth Conrad VP Quality at BD Peripheral Intervention.

Michael Ruhlen – MD, MHCM, FAAP, VP Division of Medical Education, Atrium Health

Michael Schiller – CMRP, Senior Director at the Association for Healthcare Resource & Materials Management (AHRMM)

Nathan Soderborg PhD, Principal Scientist, Statistical and Data Sciences, Exponent.

Francisco (Cisco) Vicenty Program Manager for Case for Quality, Office of Compliance, CDRH, FDA (OPEQ Pilot: Immediate Office, Strategic Initiatives Staff)

Register to Receive this Report.

22Aug/18
FDA-Pre-Check

Do You Want Less FDA Inspections? Here is FDA’s RX

Quality Metrics Program Update: We Asked and FDA Answered

By: Sandra K. Rodriguez, Market Analyst

The Quality Metrics program is a key step in the Agency’s objective to encourage industry to implement state-of-the-art, innovative quality management systems that drive industry to focus on improving product quality, rather than simply ensuring compliance to regulatory requirements.  

FDA recently published two announcements on the Quality Metrics program in the Federal Register: 

  • CDER intends to further develop a Quality Metrics Program through formal meeting requests and a pilot study to gain feedback from those establishments for which meeting requests do not apply 
  • CDER and CBER are initiating a 2018 Quality Metrics Site Visit Program to assist the Agency in understanding existing programsii 

These announcements prompted a number of industry executive to reach out to Axendia to understand FDA’s current thinking on Quality Metrics. 

For a first-hand account, we reached out to FDA with a few questions – we asked and they answered. [1]

AXENDIA: What drove the delays in the program?

FDA: There were many comments submitted to the docket after the revised draft 2016 guidance was published.  The comments generally indicated that additional feedback and a pilot would be useful.  Further, we took time to listen to additional comments and feedback from industry and industry trade organizations provided at conferences and presentations.  We determined that our next steps should be a Feedback Program and Site Visit Program which would allow individual companies an opportunity to discuss their approaches from different sub-sectors of the industry.  Continue reading