Tetra
by Scion Communications Corporation
by Scion Communications Corporation
Profile Information Last updated on: 16 July 2024
Profile Information Last updated on: 16 July 2024
We help make selecting a software for your business effortless, economical and efficient.
by Scion Communications Corporation
by Scion Communications Corporation
Profile Information Last updated on: 16 July 2024
Profile Information Last updated on: 16 July 2024
Setup Fees: One-time charges for installation and configuration.
Maintenance Fees: Regular charges for ongoing support and updates.
Support Charges: Costs for additional support services beyond standard maintenance.
Not available
ISO 9001:2015: This standard specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and regulatory requirements
ISO 27001:2022: This international standard specifies the requirements for establishing, implementing, maintaining, and continually improving an information security management system within the context of the organization
SOC 2, Type II: This standard relates to the Trust Services Criteria for security, availability, processing integrity, confidentiality, and privacy. A SOC 2, Type II report indicates that a service organization has been through an evaluation of their control activities as they relate to the applicable Trust Services Criteria
FDA 21 CFR Part 11: This regulation sets forth the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper
EMA Annex 11: This provides the European Medicines Agency's guidelines on computerized systems used as part of GMP regulated activities. The annex outlines the requirements for the development, validation, operation, and maintenance of computerized systems
Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) regulations: These are regulatory guidelines that provide guidance for manufacturing, testing, and quality assurance to ensure that a manufactured product is safe for human consumption or use
Good Automated Manufacturing Practices (GAMP) 5, 2nd edition: This provides a pragmatic and practical industry guidance to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner
FDA Computer Software Assurance (CSA) Guidance: This framework is intended to promote a risk-based approach to computer software assurance, focusing on critical thinking and assurance practices to support product quality and patient safety
By Scion Communications Corporation