Expertise.
Deviation Management.
Optimize your deviation management, ensure compliance and minimize risks
Efficient?
Can deviations in your processes be quickly identified and rectified?
Are you sure?
Do you ensure that all regulatory requirements are met?
Transparent?
Is the entire deviation process fully documented and traceable?
Optimize your deviation management for more efficiency and compliance.
Deviation management - efficiency, compliance and risk minimization.
Our deviation management services help companies in the pharmaceutical and medical technology sector to manage deviations efficiently and ensure compliance.
We help you to record, document and resolve deviations quickly and accurately in order to meet regulatory requirements and minimize risks. With digital solutions and automated workflows, we increase the efficiency of your deviation processes and ensure maximum transparency.
Our services include:
- Regulatory compliance & audit preparation: Ensuring compliance with national and international regulations (e.g. GMP, FDA, MDR).
- Efficient deviation management & process automation: Implementation of digital solutions for the automated recording and processing of deviations.
- Risk minimization & quality improvement: Identification of recurring deviations and implementation of preventive measures to ensure product quality.
Deviation Management Consulting - Solutions at a glance.
Our deviation management services offer comprehensive support to efficiently manage deviations and meet regulatory requirements in the pharmaceutical and medical technology industry.
Regulatory Compliance & Audit Preparation.
- Ensuring compliance with national and international regulations (e.g. GMP, FDA, MDR).
- Support in the preparation and implementation of audits to ensure compliance with regulatory requirements.
- Reduction of the risk of non-compliance and associated penalties.
Efficient deviation management & automation.
- Implementation of digital solutions for the automated recording and resolution of deviations.
- Minimization of manual interventions to reduce sources of error.
- Improving the efficiency and traceability of deviation processes.
Risk minimization & quality improvement.
- Identification of recurring deviations and implementation of preventive measures.
- Improve data integrity and traceability to ensure product quality.
- Introduction of real-time monitoring and reporting tools to enable rapid decision-making.
Successful deviation management projects.
Our deviation management case studies show how our tailor-made solutions have helped companies in the pharmaceutical and medical technology industries to optimize their deviation processes, strengthen compliance and increase efficiency.
Optimization of deviation management at a global pharmaceutical company
Digitalization of deviation management in medical technology
Improving audit readiness through optimized deviation management
Challenge.
A mid-sized pharmaceutical company needed to improve its audit readiness and resolve deviations faster to meet strict regulatory requirements.
Measures.
- Introduction of an audit preparation system for automated document management.
- Implementation of a standardized process for rapid processing of deviations.
- Training of employees to improve audit preparation.
Results.
- 40% reduction in the time required to rectify deviations.
- Improved compliance through optimized processes.
- Faster and smoother audit preparation.
Success.
Audit readiness significantly increased within 6 months.
Reduce deviations and increase the efficiency of your processes.
Our Deviation Management Service Portfolio.
Our Deviation Management Service portfolio offers comprehensive solutions for the efficient recording, processing and resolution of deviations to ensure your compliance and minimize risks in the pharmaceutical and medical technology industry.
We implement a structured quality risk management system to identify and evaluate deviation risks. By identifying potential risks at an early stage, we support you in controlling deviations and ensuring product quality
Our experts use Root Cause Analysis (RCA) to identify the causes of deviations. Based on these findings, we implement Corrective and Preventive Actions (CAPA) to ensure that similar deviations are avoided in the future
We ensure that your deviation processes meet the requirements of national and international regulations, including FDA 21 CFR Part 211, ICH Q7 and EU GMP. Our comprehensive compliance consulting minimizes the risk of penalties and ensures compliance with all regulations
We help you classify deviations into critical, major and minor deviations based on their impact on product quality and regulatory requirements
