Quality and Security

Persei ISOs

Persei consulting is certificated with two ISOs regarding Information security and Software maturity.

The UNE-ISO/IEC 27001 is the best practice specification that helps businesses and organisations throughout the world to develop a best-in-class Information Security Management System (ISMS).

ISO/IEC 15504 Information technology - Process assessment, also known as SPICE (Software Process Improvement and Capability Determination), is a set of technical standards documents for the computer software development process and related business management functions.

Compliance and standards

Persei creates platforms over healthcare standards and fulfills the FDA and EU laws and regulations.

Our compromise is offering ecosystems compliance with the high standards in eHealth, management of clinical information, interoperability and data security.

21 CFR part 11

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States.

CDISC Standards

CDISC is a global, open, multidisciplinary, non-profit organization that has established standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.

HIPAA

The Health Insurance Portability and Accountability Act, sets the standard for protecting sensitive patient data. Companies dealing with protected health information must ensure that the required physical, network, and process security measures are in place and followed.

HL7 CDA R2

The HL7 Clinical Document Architecture (CDA) is an XML-based markup standard intended to specify the encoding, structure and semantics of clinical documents for exchange.

SNOMED CT

SNOMED Clinical Terms is the most comprehensive, multilingual clinical healthcare terminology in the world. It contributes to the improvement of patient care by underpinning the development of EHRs that record clinical information in ways that enable meaning-based retrieval.