The 21 CFR part 11 / EU GMP Annex 11 regulations establish criteria for electronic records and electronic signatures to be trustworthy and reliable. The goal is to minimize the chances of data falsification and maximize the chances of detecting falsification.
To achieve this goal, YT-AUDIT uses advanced digital fingerprint technology and audit trailing in a highly automated manner for maximum compliance to 21 CFR part 11.
Streamlining 21 CFR part 11 Compliance with YT-AUDIT Imaging Software
Increasing efficiency not only leads to economic growth and optimal use of existing resources. It is also an essential component of competitiveness. Automation solutions are therefore more in demand than ever.
For example, digitized cell line development and production is also one of the guarantors of greater efficiency in the pharmaceutical industry. Here, the guideline of the U.S. Food and Drug Administration (FDA) 21 CFR Part 11, on "Electronic Records and Electronic Signatures," enables the transition from paper-based manual processes to computer-supported electronic processes.
This requires working with 21 CFR part 11 compliant software, such as SYNENTECS' newly developed YT-AUDIT Imaging and validation software.
Avanced Safety Features
Protection of primary data (metadata & image raw data)
Protection of derived data (processing and results)
Audit browser for validation of experiments
pdf-report for experiments or templates of the audit trail
Highly automated 21 CFR part 11 compliant Imaging and Image Processing with YT-AUDIT
All GMP-relevant automated systems must be validated to ensure accurate, reliable and consistent data processing according to specifications.
In this context, every setting that can be changed in the software and has a direct influence on the result of the object to be measured is quality-relevant. Any change to this quality-relevant setting is recorded in the audit trail.
Settings without quality-relevant influence on the product need not and should not be included in the audit trail for reasons of overview and space requirements.
YT-AUDIT now takes care of all these decisions and control mechanisms for you. Fully automated.
The three Pillars of 21 CFR part 11 Compliance
Security management by customer‘s IT
YTUser / YTManager / YTAuditor
Certification by training
Digital fingerprinting technology
Traceable validated experiment format
Data integrity check
Searchable and filterable
Exportable to pdf
Supports all common Applications needed to run your R&D Processes in High throughput
Cell Line Development (e.g. Single Cell Cloning, CRISPR/Cas9 Tracking, Transfection Efficiency, Cell Viability Monitoring, PAIA Protein Titer Measurements, PAIA Glycosylation Measurements, Fluorescent Activated Single Cell Cloning (FASCC))
Cancer Research and Drug Discovery (e.g. Imaging of 3D Spheroids, Toxicity Testing, IC50 studies, Cell Expansion Tracking, Apoptosis Monitoring, Nucleus Characterization)
Stem Cell Research (e.g. iPS Colony Count, Fluorescent Pluripotency Studies, Validation of Proliferation and Cell Migration, Cell Differentiation Analysis, Recombinant Lectin Probes)
Immunology (e.g B-Cell and T-Cell Studies, Cytotoxic T-Lymphocyte Testing, Evaluation of Helper T-Cells and Subsets, Performing Cell Death Studies)
A user-friendly software interface will give you the choice of either using a predefined set-up from a list of established assays or to define your own work flow protocol and store this into a customized template.
Both imaging systems run on the same software platform which makes it easy to transfer your process in case of upgrading from NYONE® for higher throughput of CELLAVISTA®.