What happens when the scope of your company’s business suddenly expands to new products, new regulatory status or new territories? The best option is to perform a PV “gap analysis” to understand what you need to do to meet any new regulatory obligations for your company.
What happens when you realize that the gap analysis uncovers a large number of gaps in your PV systems and capabilities? That is when it is the time to think about transformation to a new future state.
Transformation is not about just writing new SOPs: it will require significant changes in the process, way of working, mindset and collaboration spirit. Where do you begin? There are several elements to consider before embarking on such a transformation. Key questions are:
PEOPLE
Do you have leadership and staff with the right skills for the future?
Do you have sufficient resource capacity?
Do you need to restructure the work and the organization design?
What is the health of collaboration and partnership across your organization?
Effective PV requires strong partnerships with Clinical, Regulatory, Quality, Commercial and Legal. What is your assessment on that point?
INFORMATION SYSTEMS
Will the Safety Database platform support your future needs?
Will you need to merge external safety data with your database?
Is your system compliant with all future regulatory requirements?
PROCEDURES
Do you need new or updated controlled documents or policies?
Do you have a training capability to maximize compliance to the new processes?
INSPECTION READINESS
Will you be able to tell a credible story of why and how you moved to the new state, how the identified gaps were addressed, to any health authorities or partners' auditor?
OVERSIGHT
What is the health of your system for compliance and safety oversight, and should it be enhanced?
Do you have metrics that provide both leading and lagging indicators of compliance?
Do you have a formal mechanism for reviewing the safety profile of your products, even in an outsourced model?
Do you have clear and organized decision-making processes when safety issues are identified?
As you begin to transform your PV system towards a future state, a focus on organizing, resourcing and prioritizing your work is needed to move up all components in a harmonized approach.
ORGANIZING
Nothing works better than organizing logically work streams based on the nature/extent of the remediation.
PRIORITIZING
Prioritization begins with evaluation – is the gap a compliance risk or an improvement opportunity driven by resources optimization? The most critical compliance risks should be addressed first; however, it might be necessary to complete lower risk gaps in order to address the critical gaps.
RESOURCING
A decision will be needed on whether internal or external resources will be utilized to complete the work of transformation. One common mistake is to think that the teams will address the remediation/transformation in addition to their daily work. This is rarely possible. You need to find the budget to maximize the probability of success of the effort and create a sustainable and performant future state.
How do you sustain the momentum and keep the transformation on course?
We will discuss this in the second part of this topic.
Janet Uetz
JanetUetz@JPCCAssociates.com
