From extra capacity to a fully managed quality function.
Some organizations need people. Others need the work done, governed, measured and reported — without building permanent headcount to do it. ClariSure can operate defined quality functions, or substantial portions of them, under a governance model agreed with you.
Staff augmentation and managed services are not the same purchase.
Staff augmentation
ClariSure supplies qualified expertise and capacity. You direct the work, set priorities, manage throughput and own the outcome day to day.
Right when you have a plan and a gap in capacity.
Managed service
ClariSure manages the defined function, workstream or program — workload, execution, performance and escalation — against agreed objectives, metrics and reporting, under governance you approve.
Right when you need the work run, not just resourced.
Functions we can manage
In whole or in part, depending on what the organization needs and what it wants to keep.
When a managed service is the right answer
- A quality function is under-resourced and hiring is not approved, or not fast enough.
- A remediation program needs dedicated execution capacity the standing organization cannot absorb.
- A newly acquired or carved-out business needs quality operations running before permanent structure exists.
- A backlog — complaints, CAPAs, nonconformances, supplier files — needs to be worked down and handed back operating properly.
- A function needs to be rebuilt while continuing to operate. Most do.
Managed does not mean unmanaged by you.
ClariSure assesses the existing organization, designs the operating model, establishes governance, defines roles and responsibilities, deploys qualified experts, manages workload and execution, establishes KPIs and service levels where appropriate, provides management reporting, manages escalations, monitors compliance and drives continuous improvement.
Governance is agreed before the first person starts. Reporting cadence, escalation triggers, decision rights and exit conditions are documented at the outset.
Decision rights, approval authority and regulatory responsibility stay here.
Named. Accountable for delivery, reporting and escalation.
Qualified experts deployed against defined workstreams.
Scope agreed in writing before anyone starts.
Measured, reported and escalated against agreed thresholds.
A cadence you set, in a format your board can read.
ClariSure operates defined quality activities under a governance model agreed with the client. Regulatory responsibility, decision authority and legal accountability remain with the manufacturer, sponsor, specification developer, Marketing Authorization Holder or other legally accountable entity. ClariSure does not assume the regulatory obligations of the regulated entity.
Does ClariSure take on our regulatory responsibilities?
How is this different from staff augmentation?
What gets agreed before we start?
Can we bring the function back in-house later?
An extension of your quality organization — or a managed quality capability when you need one.
Tell us what you are dealing with. We will tell you honestly whether it is something ClariSure should take on, and what the path forward looks like.