2026 Operational Readiness: What High-Performing Life Sciences Teams Are Doing Now
How to prepare your quality, operations, and leadership teams for a more complex regulatory and operational landscape.
December 2025
As 2025 comes to a close, life sciences leaders are taking a hard look at their operational foundations. Between shifting FDA expectations, resource shortages, and rising complexity, teams that are preparing early will see the biggest operational wins in 2026.
To help you assess where you stand — and where to focus — we’ve highlighted some key areas to show what operational readiness looks like in 2026:
- Quality Systems Must be Strong Enough to Withstand Pressure
Audit readiness has evolved from gathering essential documents to ensuring sites have repeatable processes, clear ownership, and evidence of effective remediation. It is imperative to success to have a level of quality system maturity that holds up when things get complicated.
In practice, this looks like:
- Investigations closed within standard timelines, with extensions as rare exceptions
- Documentation that isn’t just standardized– but consistently lived day-to-day
- Proactive trending of deviations, not just retrospective clean-up
- Strong effectiveness checks on CAPAs
- Audit readiness extending beyond internal teams to critical suppliers
These foundations don’t just help companies pass inspections– they help avoid the operational pitfalls of rework, firefighting, and daunting backlog.
- Capacity Planning Has Become a Strategic Advantage
This year, teams were stretched thin and expected to do more with less. The organizations that delivered on their 2025 commitments weren’t necessarily larger– they were more flexible.
High-performing teams approached capacity proactively by:
- Forecasting workload early
- Mapping capability gaps across functions (QA, QC, Ops, Regulatory, etc.)
- Bringing in specialized consultants to bridge temporary surges
- Filling niche skill needs without over-hiring
In one engagement, a client’s daunting warning letter activities were quickly acted upon with a targeted deployment of OQSIE consultants– allowing our client to complete commitments ahead of schedule. That kind of agility will define success in 2026.
- Predictive Analytics is Moving from “Nice to Have” to Core Infrastructure
For years, AI in life sciences has been centered on potential. In 2025, more companies started experimenting with advanced solutions. Those teams that have embedded predictive tools have gained deeper visibility and will gain higher performance rewards in 2026.
The foundations matter. The organizations that saw meaningful impact weren’t the ones with the most sophisticated models — they were the ones that had:
- Clean, trustworthy data
- Clear business problems to solve (investigation cycle time, downtime, capacity forecasting, etc.)
- Leadership support for change
- Collaboration across functions
- Willingness to pilot, iterate, and refine
The result? Faster decision-making, less surprises, and fewer last-minute escalations. In an industry defined by compliance and timing, predictive insight is becoming more than just a competitive advantage.
- Supplier and Third-Party Oversight Can’t Lag Behind
With more life sciences organizations depending on contract manufacturers and third-party partners, 2025 exposed a critical truth: your suppliers must be as audit-ready as your internal teams — because their failure becomes your risk.
Teams that got this right:
- Conducted early supplier assessments
- Ensured documentation quality matched internal expectations
- Implemented monitoring and trending for supplier deviations and changes
- Performed readiness checks well before FDA interactions
- Built regular communications between internal teams and external sites
OQSIE saw this firsthand when we helped a U.S. client prepare a third-party manufacturer in China for a PAI audit. After a structured gap analysis and targeted remediation, the site passed with flying colors — and passed a follow-up audit two years later with zero observations.
- Cross-Functional Alignment is the Glue That Holds Everything Together
Even the best systems and tools fail without consistent alignment. This year, the strongest teams were the ones that broke down silos between QA, QC, Regulatory, Supply Chain, and Operations. They had shared priorities, dashboards, and ownership of outcomes.
These teams thrived because:
- Everyone had the same view of risks and timelines
- Communication was consistent — not crisis-driven
- Escalations were predictable
- Leadership signaled clear support across functions
As 2026 approaches, cross-functional alignment isn’t simply “nice to have.” It’s the mechanism that keeps companies steady when inspections appear and timelines compress.
So, what does 2026 operational readiness look like?
It is starting the year with:
- A QMS that works under pressure
- The talent and expertise to execute without bottlenecks
- The operational maturity to benefit from predictive tools
- Suppliers who won’t introduce hidden risk
- Teams aligned around shared priorities and clear governance
Organizations that invest in these pillars will be able to operate with confidence, consistency, and control.
And if you’re not sure where to start? That’s exactly what we’re here for.
OQSIE helps life sciences companies strengthen systems, build capacity, implement predictive tools, and prepare both internal teams and suppliers for regulatory success. Let’s talk about your 2026 plans and how we can help execute them.