Validation of Processes and Methods
Ensures quality and reliability in production and analysis
The validation of processes, equipment, and analytical methods is essential to ensuring that products meet defined requirements and quality attributes in accordance with regulatory guidelines. We support organizations in validating and maintaining robust processes that ensure consistent quality over time.
Challenges
Common challenges
Clear parameters, proper testing, and traceability are crucial for consistent quality
Validating processes and methods involves ensuring that critical parameters are clearly defined, controlled, and documented throughout the entire process. Challenges often arise when requirements, equipment, and testing are not fully synchronized.
Lack of traceability in how critical parameters are defined
Differences Between Specifications and Actual Equipment Performance
Inadequate documentation for audits and troubleshooting
Unclear criteria for what constitutes a validated process
Testing that does not cover all relevant risk scenarios
Lack of relevant expertise and resources
We Offer
Practical Validation of Processes and Methods
From validation to stable, reproducible, and reliable results
We support organizations in validating processes, equipment, and analytical methods to ensure they meet defined requirements and deliver reliable and reproducible results. A structured, risk-based approach ensures that the focus remains on critical parameters and quality attributes. Throughout the entire lifecycle—from equipment qualification (IQ, OQ, PQ) to the validation of manufacturing steps and analytical methods—we contribute to robust documentation, reduced nonconformities, and long-term, stable quality.Process Validation
Ensures that manufacturing processes consistently produce products that meet defined requirements.
Equipment Qualification (IQ/OQ/PQ)
Ensures that equipment is installed, operates, and performs in accordance with specified requirements.
Calibration and Equipment Validation
Ensures precision, reliability, and proper operation of equipment and measurements.
Risk-Based Validation
Focus on critical parameters to minimize risk and ensure quality and compliance.
Ongoing validation support
Support for rehabilitation, follow-up, and long-term quality assurance over time.
Value We Create
Reliable processes with consistent and reproducible quality
Verified Critical Quality Attributes (CQA) and Process Parameters (CPP)
Greater control and predictability in production
Fewer deviations and production defects
Structured documentation that ensures regulatory compliance
Customer cases
Here's How We Overcame Past Challenges
Validated manufacturing process ready for the market
Problem: An IVD startup needed to validate its production process in order to launch its first commercial product. At the same time, it lacked established procedures and structures for qualification and validation in accordance with regulatory requirements.
Solution: We developed customized processes for qualification and validation and defined a strategy for production validation. The work included risk analyses, documentation, and the qualification of equipment and systems for production and quality control.
Results: A fully validated production process and certified equipment enabled a smooth transition to commercial production. The customer gained a scalable structure that ensures regulatory compliance and reduces risk as the company continues to grow.
Process Validation
Ensures that manufacturing processes consistently produce products that meet defined requirements.
Equipment Qualification (IQ/OQ/PQ)
Ensures that equipment is installed, operates, and performs in accordance with specified requirements.
Calibration and Equipment Validation
Ensures precision, reliability, and proper operation of equipment and measurements.
Risk-Based Validation
Focus on critical parameters to minimize risk and ensure quality and compliance.
Ongoing validation support
Support for rehabilitation, follow-up, and long-term quality assurance over time.
Common challenges
-> Lack of traceability in how critical parameters are defined
-> Differences between requirements and actual equipment performance
-> Inadequate documentation for audits and troubleshooting
-> Unclear criteria for what constitutes a validated process
-> Testing that does not cover all relevant risk scenarios
-> Lack of relevant expertise and resources
Features and benefits
-> Reliable processes with consistent and reproducible quality
-> Verified critical quality attributes (CQA) and process parameters (CPP)
-> Greater control and predictability in production
-> Fewer deviations and production defects
-> Structured documentation that ensures regulatory compliance
CONTACT
Talk to someone who knows your area
Karin Tördahl
Head of Unit Quality & Validation
Karin Tördahl
Head of Unit Quality & Validation