For Laboratories from R&D to QC
Whether you need versatility and flexibility for FFF method development or want the most consistent data obtained in a regulatory environment, Wyatt Technology’s FFF-MALS system will support a wide variety of biotherapeutic characterization needs.
ASTRA and VISION software packages have been developed under a formal quality system and are available in 21 CFR Part 11 compliant options that fulfill GMP and GLP requirements. Wyatt’s compliant software has been used and validated by hundreds of biopharmaceutical laboratories.
VISION SP: Central Compliance Hub for FFF-MALS
Launch VISION’s central hub and log into VISION which automatically starts ASTRA – both in security pack mode. VISION will automatically apply the same user roles with VISION RUN and synchronize data acquisition in ASTRA SP.
Everything is traceable: Each FFF method in VISION is linked to its corresponding ASTRA data file and vice versa. All results are stored in a joint, secure SQL database. All VISION RUN and ASTRA events and changes are recorded in the audit trail. Explore our blog post and white papers on ASTRA and VISION compliance to learn more.
Get Ready for GMP Compliance: Standardization and Protocols
Wyatt’s FFF-MALS system with 21 CFR Part 11 compliant VISION and ASTRA software aids regulatory efforts and the development of standards and validation protocols.
Robust and high-quality standard operating procedures (SOPs) are critical for accurate measurements, especially for complex drug nanoformulations that are often inherently polydisperse. Recently, government research labs such as the European Union Nanomedicine Characterization Laboratory (EUNCL) and the National Cancer Institute-Nanotechnology Characterization Laboratory (NCL-NCI) have jointly developed a robust standard operating procedure for the analysis of key quality attributes, such as particle size, shape, drug loading and stability of complex nanomedicine formulations.
A Complete 21 CFR Part 11 Compliance Package
Complete your compliance package with validation and services. Wyatt offers a comprehensive IQ/OQ package for instrumentation and software, including documentation and onsite validation.
Three levels of all-inclusive service plans are available: Platinum, Gold and Silver. Key benefits of the Platinum and Gold Service Plans are onsite preventative maintenance, repair services with all parts and labor included and dedicated loaner units should an instrument require factory repair.