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Compliance/Quality

Safe. Secure. Quality Assured.

PDS products are built to meet the most rigorous regulatory and compliance standards. Furthermore, our software is not reliant on third-party software — all reporting and statistics can be performed within our programs. PDS provides the only GLP-compliant hosting service, with regularly scheduled GLP inspections of hardware and software components and related installation qualification documents. In addition, our hosting service undergoes regular inspection to ensure conformance to ISO standards relating to key performance indicators, such as server availability and reliability, support and backup, and adherence to subscription and licensing agreements. Certificates for the GLP and ISO inspections are available on request.

CDISC

As an active member and Registered Solutions Provider (RSP) of the Clinical Data Interchange Standards Consortium (CDISC), PDS upholds CDISC standards to ensure high-quality, standardized data.

PhUSE

Key staff of PDS are also members of the Pharmaceutical Users Software Exchange (PhUSE), an independent nonprofit organization that facilitates worldwide discussions between data managers, biostatisticians, statistical programmers and eClinical IT professionals.

ISO Standards

The complete PDS software development and implementation process adheres to published international standards for quality management and quality assurance. ISO-9001 standards are applied to system development and maintenance. More specifically, every program function is extensively validated for its basic program-level functionality as well as for its integrated system functionality.

GLP Standards

Our software is fully compliant with applicable GLP requirements,1 including 21 CFR Part 11, and offers integrated audit trails, amendment control, password protected user accounts and program privileges, as well as complete animal reporting functionality. In fact, when delivered as SaaS, Ascentos, your preclinical software solution, is the world’s only GLP-certified hosted solution. PDS software also ensures the data you’re collecting is plausible. All animal data is distilled using a complex algorithm that only permits error-free, logically sound data. With PDS, scientists can feel confident that the study evaluation is accurately performed and reported and doesn’t require a tedious tabular data review.

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1: The Good Laboratory Practice (GLP) is based on the OECD principles of GLP issued on 26th November 1997. The ordinance on Good Laboratory Practice (OGLP, SR 813.112.1) was issued on 18th May 2005 and enacted on 1st August 2005.

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