Quality Built to Protect License to Operate
Build stable quality operations that support inspections under pressure and keep teams aligned across functions.
We bring hands-on QA, QC and manufacturing experience together with cross-functional insight, strengthening both inspection outcomes and daily execution.
Common challenges in quality
Quality fragmented across functions
QA, QC, manufacturing, regulatory and engineering all contribute to quality, but requirements are often interpreted differently. Ownership becomes unclear and handovers rely on personal habits rather than shared rules.
Over time, small inconsistencies accumulate into backlogs, recurring deviations and corrective actions that never fully close.
QMS no longer fits daily operations
Many QMS frameworks were designed when portfolios were smaller and product flows simpler. As operations and supply chains grow more complex, procedures drift away from reality.
Updates are postponed, training lags behind and paper or hybrid setups make scaling difficult across sites.
Uneven digital maturity
Some teams work digitally while others rely on spreadsheets, email and shared folders. Metadata varies, content lives in multiple systems and change control breaks when inputs arrive in different formats.
Without a unified content structure, quality information fragments and execution slows.
Inspection readiness under constant pressure
Teams juggle deviations, change controls, supplier actions and daily support tasks with limited capacity to close findings or stabilize documentation. Quality debt builds quietly until inspections approach, making outcomes less predictable and increasing risk to business continuity.
We solve this by
Quality governance and operating models
We assess how quality functions today, identify where ownership blurs and handovers fail, and design governance models that create clear accountability across QA, QC, manufacturing, regulatory and engineering.
Modern QMS and validated systems
QMS modernization aligned with how work actually happens. We configure and validate systems and support adoption so teams trust the QMS as a daily working tool instead of building parallel workarounds.
Enterprise content management for quality
We design ECM setups that standardize metadata, reduce duplication and connect quality content across sites and functions. Quality information becomes easier to find, maintain and rely on in everyday operations.
Inspection readiness and remediation
Targeted gap assessments, mock inspections and remediation work led by consultants who know what authorities focus on. We help close known weaknesses and build routines that keep inspection readiness stable, not reactive.
Operational quality support
When backlogs build, we add hands-on capacity for deviations, CAPAs, change controls and supplier qualification. Managed QMS administration and compliance monitoring keep operations inspection-ready without adding permanent headcount.
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What effective quality operations look like
Processes that match reality
Procedures, roles and workflows reflect how work is done, not outdated assumptions. Teams share a common quality language across functions and sites.
Digital systems that support execution
QMS and ECM provide structure, traceability and clarity. Metadata is governed and information flows predictably through the value chain.
Confident inspection readiness
Documentation, training and governance stay current. Teams explain decisions clearly and demonstrate control without last-minute preparation.
Stable operations and protected license to operate
Backlogs shrink, deviations decline and cross-functional collaboration improves. Quality supports execution instead of slowing it down.
Hear from our clients
Practical results delivered through deep life science expertise.
Why life science companies choose Epista
Quality expertise from inside operations
Our consultants have worked inside QA, QC, manufacturing and regulated operations. They understand inspection pressure and what good looks like in practice.
Inspection readiness across the full landscape
We address quality across processes, systems, facilities, equipment, data and training. Nothing falls between organizational gaps when inspectors arrive.
One partner from strategy to execution
Governance design, QMS modernization, ECM implementation and operational support delivered as one coherent effort rather than fragmented initiatives.
Cross-functional perspective that fixes root causes
By bridging quality, operations, engineering and regulatory, we solve underlying issues instead of treating symptoms that reappear at the next inspection.