What is FDASIA, Title VII?

By Dee Carri, Monday, 3rd November 2014 | 0 comments
Filed under: BPM, Business Process Management, SOPs, Work Instructions, TPSoP®, IT, Quality, Compliance, Operations, Training.

What is FDASIA, Title VII?

Dee Carri looks at what Title VII of FDASIA regulation is, the timeline for its implementation, how it's going to affect Quality Managers, Business Process Managers and IT Managers and offers some strategic advice to stay ahead of the curve and organise for success.

In 2012, the FDA Safety and Innovation Act, (FDASIA) was passed by the US Congress and signed into law by President Obama. This is a far-reaching bill that is will have a significant impact on the future operations of the FDA and the Life Sciences sector.

Amongst the many provisions contained in FDASIA, Title VII is of particular interest to Quality Managers, Business Process Managers and Information Technology Managers. This title of the Bill increases the FDAs ability to:

  • Collect and analyse data to enable risk-informed decision-making
  • Advance risk-based approach to facility oversight – part of broader shift towards more strategic, risk-based approach to regulation and enforcement


  • Section 705 introduces risk-based inspection frequency. It eliminates minimum inspection frequency requirement for domestic drug establishments and requires FDA to target both domestic and foreign inspections on the basis of risk.
  • Section 706 deals with records for inspections and it allows FDA to request and obtain records – electronically or in physical form – in advance or in lieu of an inspection

In response to these new requirements, FDA has indicated that it intends to collect a standard set of quality metrics data from Life Sciences companies which will be used to inform its risk based approach. It has undertaken preparatory work, published a paper in April 2014 and continues to engage in discussions and a pilot programme with industry to understand the type and frequency of metric that might be most suitable to its purpose.

For its part, the industry representative bodies have also been busy:

  • Developing and proposing a standard set of quality metrics
  • Developing and proposing standard definitions for these metrics

These activities are wide-ranging and still under discussion and development both within industry and in the FDA itself.

Current proposed timetable for Implementation of quality metrics

The latest information available from FDA suggests that:

  • 4th Quarter 2014: Publication of FRN (Federal Registration Notice) and draft guidance is targeted
  • 3rd Quarter 2015: Publication of Final Guidance; Data Collection will be initiated
  • Following implementation in 2015, there may be an initial learning period of 12 months (no sanctions as a result of data collection).

In October, FDA indicted that its current thinking is to collect an initial set of 9 metrics at a site and product level and that it will require quarterly data to be provided on an annual basis.

Why is this important to Quality Managers, Business Process Managers and IT Managers?

  1. Quality Managers will need to align internal metrics programmes with the proposed FDA Metrics to ensure that they are collecting the right data.
  2. Business Process Managers will need to develop robust, repeatable processes for the collection of metrics data, verification, approval and publication of the metrics.
  3. IT Managers will need to develop or align existing information management systems and infrastructure to support the metrics programme.

This task is not trivial and will stretch all organisations, small and large:

  • Smaller organisations lacking sophisticated management (and metrics) management systems will be seriously daunted by the physical task of introducing standard metrics and definitions, collecting, verifying and publishing metrics
  • Large organisations, operating in multiple locations and globally will face challenges of the introduction of new disciplines of standard definitions, associted metrics and the aggregation and integrity of large data sets.

Strategic Advice

For good or bad, FDASIA is a legal requirement and the FDA metrics programme is here to stay. All life Sciences organisations are affected by the Metrics Programme and need an enterprise-wide strategy and a firm plan to ensure they can meet reporting dates. An ad-hoc, local response is inappropriate in this situation as it is likely to be more expensive, less efficient and may expose the organisation to unnecessary regulatory scrutiny. Furthermore, the effort to comply should not be underestimated as it is a big task and there is plenty of evidence – formal and anecdotal, that suggests most organisations will struggle to comply.

For these reasons, it is important not to wait for final guidance but to start now on an implementation programme.

There are two initial tasks that organisations can undertake now without waiting for further guidance:

1. Organise for Success: set up a FDASIA Metrics programme Steering Group to manage the programme

The initiative is strategic, it will be rolled out over a period of years and it needs an enterprise-wide approach. Therefore, a Steering Group should be created and charged with the development of a strategy and implementation of the programme. This steering group will need the appropriate governance, authority and resources to enable it to operate on an enterprise –wide basis. To ensure all aspects are considered, the steering committee should include representatives from Quality Management, Business Process Management and IT Management.

Deliverable: Infrastructure (organisation, processes, systems), plan, budget and other resources necessary for the successful delivery of the FDASIA Metrics Implementation Programme

2. Conduct an initial assessment of the current ability to report quality metrics

This activity requires an assessment of the organisations current capability to meet reporting requirements at a product and site level. As such, the assessment will need to include at a minimum:

  • Metrics, standard definitions, governance
  • Data collection processes and timing, verification of dataset / integrity processes, reporting processes, reporting frequency
  • IT enabling tools and business information systems

Deliverable: Current Quality Metrics Reporting Capability Assessment

Completing these tasks now will put the organisation slightly ahead of the curve in terms of timeline, it will also provide a strong basis for the metrics programme, it will reveal weaknesses that can be addressed in advance of draft guidance and it will accelerate the development of an implementation plan.

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