Pharmacovigilance Systems and Processes Standards

PS² defines open, vendor-neutral business process, information, interoperability, and system standards for safety management across the life sciences. It aims to reduce implementation costs, simplify regulatory compliance, and accelerate innovation through modular, best-of-breed technology ecosystems. Originally focused on pharmacovigilance, the initiative has expanded to vaccine safety and medical device vigilance, recognizing the growing convergence of safety operations and the need for harmonized digital standards across product types.

Executive summary

The Pistoia Alliance Systems & Processes Standards (PS²) initiative is a global, industry-led collaboration to establish open, vendor-neutral standards for safety management across drug safety, vaccine safety, and medical device vigilance. By defining common business processes, system requirements, information models, interoperability standards, and APIs, PS² enables organizations to implement interoperable, best-of-breed safety ecosystems while reducing implementation costs, simplifying regulatory compliance, and accelerating innovation. The current phase completes the Safety Intake standards and develops the Case Processing standards, together with a shared information model, interoperability standards, and open APIs spanning both capabilities, while also assessing the feasibility of a single worldwide safety repository.

The Problem

Although safety system requirements are broadly similar across pharma organizations, every Marketing Authorization Holder (MAH) independently defines its own specifications for system procurement and implementation. Additionally, pharmacovigilance software solutions currently don’t support interoperability, making it difficult for MAHs to adopt and connect best-of-class systems. Both aspects lead to duplicated effort in assessing and deploying pharmacovigilance systems, drive up cost and complexity for buyers and vendors alike, force widespread customization, and ultimately stifle innovation across the industry.

Our Solution

PS² is a multi-year, pre-competitive project that establishes common, industry-vetted standards for safety systems: the business processes, system and interoperability requirements, information models and APIs that let organizations stop reinventing specifications individually.

PS² also builds an operational model to sustain standards and to certify software solutions against them. The project advances module by module across successive phases, each with its own objectives, milestones, and deliverables under the overall solution.

This phase completes the standards for Safety Intake and creates the standards for Case Processing for drug, vaccines, and devices. The phase will build an extensible information model across both modules and define the interoperability standards (including standard APIs) that let systems work together.

As part of a drive to bring thought leadership into the discussion on pharmacovigilance, organizations participating in PS² will assess the case for a single worldwide safety repository.

Planned deliverables, milestones and activities for this phase include:

Safety Intake standards: Business processes, functional and non-functional system requirements for capturing safety cases.
Case Processing standards: The equivalent set of standards for processing safety cases.
Extensible information model: A logical data model and corresponding data dictionary spanning both modules.
Interoperability standards and APIs: Canonical data-exchange models and standard API specifications.
Traceability matrix: Linking requirements through the information model to the interfaces.
White paper: The benefits of a single worldwide safety repository and what it would take to implement it, given all stakeholders and constraints.
Webinars: Interactive sessions designed to showcase progress and milestone as they are completed.

Who & Why

This initiative is for anyone shaping how pharmacovigilance is run and resourced: patient-safety and pharmacovigilance leaders, safety-systems and IT owners, quality and compliance teams, procurement and vendor-management at MAHs, as well as PV software vendors and system integrators who build and deploy current solutions.

Pharmaceutical companies benefit from:

Improved compliance: the Pistoia Alliance legal framework lets organizations share early information about inspections and leverage standards to address industry-relevant issues.
Cost and time savings: shared standards for solution selection and implementation eliminates effort in building specifications from scratch.
Faster innovation: integrating standardized processing modules that are automatable allows redirecting staff time and resources to higher-value work.
Influence over software roadmaps: developing cross-company aligned, mature system requirements shapes what vendors build.

Value for system vendors and integrators includes: