Quality & Compliance
Clear standards. Confidence at every stage.
Meeting specifications depends on defined requirements, careful measurement, and ongoing control. Alentra brings together process qualification, dimensional inspection, and quality controls, with documented results supporting each program from development through commercial production.
Quality & Compliance
Clear standards. Confidence at every stage.
Meeting specifications depends on defined requirements, careful measurement, and ongoing control. Alentra brings together process qualification, dimensional inspection, and quality controls, with documented results supporting each program from development through commercial production.
INTEGRATED QUALITY
Defined requirements. Documented quality.
Quality starts with a clear understanding of program requirements. Alentra integrates quality planning, inspection, and documentation into development and production, helping verify that parts meet specifications and maintaining records that support full traceability.
Quality Planning From the Start
Program requirements guide customized quality control plans and inspection methods.
Process Monitoring & Analysis
Statistical analysis and documented checks help assess process performance and identify variation early.
Dimensional & In-Process Inspection
Specialized measurement equipment and on-floor inspections verify parts against defined specifications.
Documentation & Traceability
Detailed records, supplier and material control, and documented traceability support each program throughout the manufacturing lifecycle.
OUR QUALITY POLICY
“Alentra is committed to delivering reliable, effective, and compliant components, subassemblies, and finished products to our customers, from initial process development through full-scale commercial production. We achieve this by complying with customer specifications, quality agreements, and applicable regulatory requirements; maintaining the effectiveness of our quality management system; designing manufacturing processes for manufacturability, and applying risk management throughout the product lifecycle, while communicating openly with customers, delivering on time, and keeping complete, traceable records.”
QUALITY CREDENTIALS & DOCUMENTATION
Credentials you can verify.
ISO 13485:2016
Our quality management system is certified to ISO 13485:2016, the core standard for medical device design and manufacture.
FDA Registered
Registered with the U.S. FDA, supporting regulated medical device, drug delivery, and diagnostic production.
ISO Class 7 & 8 Cleanrooms
Controlled cleanroom environments across multiple facilities support medical, drug delivery, and diagnostic manufacturing.
Supplier & Material Control
Controlled supplier and material processes support medical-grade material traceability and consistent product quality.
VALIDATION & QUALITY SERVICES
Verification throughout the program lifecycle
Qualification, inspection, and documented controls support your program from development through production.
Qualification & Validation
Installation, operational, and performance qualification (IQ, OQ, PQ) verify equipment and processes against defined requirements.
Risk Management & FAT
FMEA, risk management support, and factory acceptance testing (FAT) with documentation help identify and control risk early.
Process Monitoring & Control
Statistical process control and ongoing monitoring help maintain stable, repeatable processes over time.
Quality Reporting & Improvement
Inspection results, corrective actions, and failure analysis guide continuous improvement.
TESTING & INSPECTION
Verified through measurement
Accurate testing and measurement provide the data needed for confident quality decisions. Our capabilities verify dimensional and performance requirements, with documented results supporting each program's quality objectives.
Full-Dimensional Layout Inspection
Complete dimensional inspection with specialized measurement equipment verifies every feature against specified tolerances.
Vision Inspection
Non-contact vision systems measure small, otherwise hard-to-measure features with precision.
Centralized & On-Floor Inspection
Inspections in centralized quality labs and on the production floor, along with in-process QC, verify parts throughout production.
PPAP & Capability Studies
Capability studies and PPAP reviews demonstrate process reliability before production begins.
Sample Parts & Approval Data
Sample parts and supporting data are provided for final customer approval before production.
Test Method Development & Verification
Custom test methods and design verification and validation testing confirm product performance against defined requirements.
QUALITY DOCUMENTATION
Clear Documentation. Informed Decisions.
Selecting a manufacturing partner requires a clear understanding of their quality systems, validation approach, and inspection capabilities. Our team can review the supporting documentation each program requires.
GETTING STARTED
What to Know When Evaluating a CDMO
Learn More
Why Alentra
Let's Start With Your Quality Requirements
Share your specifications, validation needs, and documentation requirements. Our team will help define the quality support your program needs from development through production.