Analytical Support
Validation and transfer of methods, validation of equipment control information systems—Qualilab, a consulting and training firm specialized in analytics, adapts its practices and documentation to your context while ensuring compliance with current standards, with a constant focus on maintaining the integrity of your data.
oUR SERVICEs
Validation and Analytical Transfer
Qualilab can help organize and implement analytical method transfers according to the following test and analysis standards: ISPE guides, STP Pharma Pratiques texts, and scientific publications (JPBA – Chemometrics and Intelligent Laboratory Systems):
- Drafting of protocols with selected criteria
- Implementation of experimental plans
- Statistical testing and report writing using recognized and validated software compliant with technical and regulatory standards
- Training in validation and transfer methodology, as well as in the use of statistical tools
Computer project in the laboratory
Our expertise in analytical processes and laboratory equipment (LIMS, ELN, GED, SDMS, equipment control systems such as chromatography, data processing, etc.) allows us to support you in:
- Writing specifications and selecting tools (computerized systems and/or equipment)
- Validating systems that control laboratory equipment
- Evaluating equipment qualification services (review of supplier documents, monitoring of interventions, etc.)
Qualilab also markets software solutions related to the life cycle of analytical methods.
Data processing
We can perform statistical analyses for you:
- Process and help interpret stability results (e.g., predicting shelf life)
- Calculate uncertainty in your results
- Perform graphical and statistical analysis of results
OUR TRAINING COURSES
As a certified training organization, Qualilab offers training modules tailored to laboratories:
- 3M1: Applied statistics in analytical development and quality control
- 3M2: Analytical validation and transfer
- 3M3: Analytical validation with e.noval®
- 4I1: Validation and compliance of Information Systems
- …
Why choose Qualilab
Qualilab actively works with laboratories in the implementation of method validations, based on the following texts or test and analysis standards: ICH, FDA, pharmacopoeias, STP Pharma Pratiques, NF T90-210, NF V03-110, ISO 5725, EURACHEM Guide, GUM, publications (JPBA, etc.).
A team at your service
Our team is at your service to advise and support you in managing your project. Our consultants are available, if needed, to provide insights into the content of our services.
