Quality
ISO 9001 and ISO 27001 certifications ensure highest data quality, security, and privacy
Strict Quality Control throughout the solution life cycle
Your organization has high expectations for quality, and you need software solutions from a supplier who can live up to those same ideals. With ISO 9001 and ISO 27001 certifications, and a cultural commitment to high standards, LabVantage meets those demands.
Through the oversight in the Quality Management System (QMS), Information Security Management System (ISMS), software development life cycle (SDLC), software validation, software release, software resolution (bug fix), vendor management, and resolution of customer issues, our strong processes ensure that quality is present in every aspect of our work.
Our quality team is made up of individuals with expertise in a wide variety of industries and products. They supervise five areas of responsibility:
- Quality Management System (ISO 9001)
- Information Security Management System (ISO 27001)
- Quality of out-of-the-box software
- Product issues, such as bugs in functionality
- Customer assistance for any questions or issues around performance, processes, or deliverables.
These multiple facets of quality are all treated as high priority, getting the attention and resources to ensure compliance and validation for the entire LabVantage platform: LIMS, ELN, LES, SDMS, and Analytics.
As an ISO 9001-certified company, our solutions are built and delivered within a strong QMS, employing safeguards like document control, records management, and change control to track any changes and manage who has authority to make changes.
Our ISO 27001 certification addresses the security of our solutions, our daily operations, and the data security and privacy of any personal and company data that we may have within our care. The entire ISMS ensures your data and privacy are maintained through the compliance to ISO 27001, EU GDPR, UK Data Protection Act 2018, Swiss Federal Act on Data Protection, and US data protection laws, as well as the Transatlantic Data Privacy Framework.
We also support the pre-validation of our out-of-the-box software, giving labs and organizations a head-start on their own validation process – a job that otherwise can be highly time-consuming and tedious. By providing advanced testing documentation, we save countless hours / months of work. With LabVantage you have a worry-free system you can trust.
- Labs are assured their LabVantage solutions meet GAMP 5 and follow IEEE 1012 standards
- All major and minor releases are tested against the Top 10 OWASP for cyber security vulnerabilities
- We provide validation documentation (protocols, requirement specifications, traceability matrix, summary reports, etc.), unexecuted test scripts, and executed test scripts with objective evidence verifying the software functionality. This also includes 21 CFR Part 11 / Annex 11 testing.
- Strong management systems to ensure customer and applicable regulatory requirements are met, as well as data security, integrity, and privacy requirements
Functionality
The quality team oversees the QMS and ISMS, SDLC, and the software validation. Once all activities have been satisfactorily completed and verified for acceptance, we are the ones who ultimately release the software. The quality team also answers any questions customers may have around the pre-validation of the out-of-the box solution.
ISO 9001 and ISO 27001 certified
Our robust, mature management systems ensure ongoing adherence to top standards, driving a culture of continual improvement and compliance with our proven processes. Key elements of ISO 9001 include, but are not limited to, management review, external provider management, customer complaint management, document control, record control, risk assessment, investigation, corrective action, preventive action, internal auditing, external auditing, change control, training, and validation. The ISO 27001 standard addresses data security, data privacy, data integrity, and data breach, all areas in which LabVantage provides stand-out performances.
Support and bug fixes
Although LabVantage beats industry standards for the number of bugs reported per million lines of code, our quality team works with customers and product development to prioritize, define, and resolve these issues as quickly as possible when they are identified.
Resolution of issues
If a customer has questions or concerns about our processes and what to expect – from what the delivered solution entails to its validation – they contact our quality team. We investigate and work with product management and professional services to find a resolution for the customer as quickly as possible.
