Did you know...?
300
HOURS WASTED
Average time wasted annually by every knowledge-based employee (e.g. engineers, analysts, scientists) seeking knowledge to do their job
[APQC, LipaGroup]
47X
BY REGULATORS
Frequency of 'knowledge' and 'knowledge management' references in
ICH Q10 and ICH Q9(R1)
[ICH]
$31.5
BILLION COST
Annual cost to
Fortune 500 of failing to share knowledge (relearning, rework, inefficiency), an average of $63,000,000 per company
[IDC]
#1
PAIN POINT
Top rated problem for tech transfers to CMOs / third parties: the availability of manufacturing process knowledge
[McKinsey]
Many opportunities for action...
GRade "D"
"ineffective"
Research shows that the of effectiveness of tacit knowledge transfer
(i.e., know how)
during technology transfer is generally "ineffective"
[PRST]
3 of 4
lack strategy
Only 1 in 4 biopharma organizations have mature & measured KM program
[McKinsey]
only 4%
LINK QRM & KM for PQS EFFECTIVENESS
QRM (Quality Risk Management), along with KM, are the foundation of a modern PQS per ICH Q10, yet few use together to reduce risk and inform decision making [PRST]
20%
MISSED OPPORTUNITY
Productivity opportunity from a meaningful lessons learned process [HBR];
one major biopharma reported $50MM savings over 5 years
[WCBP 2023]
WHAT WE DO
Taking Your Business to the Next Level:
KM as a 'HOW' for
stronger science, leaner systems,
higher quality and empowered people
KM Strategy & Roadmapping
Identify both existing pain points and proactive improvement opportunities to align knowledge goals with operational, quality, and people priorities.
Enhance PQS Effectiveness
Operationalize KM within your Quality Management System, aligning with ICH Q10 and Q9(R1) guidance.
KM Maturity Assessment
A diagnostic review to benchmark your current KM practices and provide a roadmap for improvement.
KM Practice Development
KM best practices to ensure knowledge 'flow', tailored to the need of your organization, strategic objectives and cultural norms.
Workshops & Training
Custom learning experiences to build organizational KM competency and a culture of knowledge 'excellence.'
