Supporting Regulatory Compliance
Regulatory Compliance
Phase Forward was founded to meet the highly-regulated environment surrounding health care companies and organizations, providing innovative technology and industry-leading services that help our customers collect, manage and report clinical trial and safety data. For this reason, our software products and services must comply with the requirements of all applicable regulations and directives. Computer validation practices are essential to our business success and are integrated into the normal workflow of all Phase Forward activities related to the design, development, delivery and deployment of our products.
Phase Forward products and services enable compliance with global regulations and guidance(s). This includes:
FDA:
- 21 CFR Part 11 Electronic Record; Electronic Signatures
- Guidance for Industry: 21 CFR Part 11 – Scope and Application
- Guidance for Industry: Computer Systems Used in Clinical Trials
- Guidance for Industry: General Principles of Software Validation
International:
- ICH Guidelines (E6 – GCP)
- EU Data Protection ACT
- Volume 10 - Clinical trials Medicinal Products for human use in clinical trials (investigational medicinal products). July 2006 - First Edition
A critical goal of Phase Forward is to ensure that customers are able to achieve regulatory compliance throughout the entire clinical trial process. Quality and regulatory compliance are achieved through a variety of means, including:
- Robust, mature, quality management system governing the Phase Forward product software development lifecycle, services delivery and IT infrastructure hosting services
- Rigorous program of internal and supplier audits to ensure process compliance throughout
- Quality System documentation providing evidence of compliance to U.S. and global regulations
- Liaising with Customers and FDA (CDER and CBER) on: clinical strategy, security, and implementation of EDC
- Proactively monitoring and commenting on regulations/guidelines
Quality System
Phase Forward’s Quality System is adapted from the FDA Quality System Regulations and ISO 9001. This includes policies and procedures governing: Software Development Life Cycle (SDLC), Audits (internal, customer, vendor, and regulatory agency), Security and Privacy, Services Delivery, and Corrective/Preventive Action (CAPA).
Quality System Documentation Model
When working with customers and partners, we apply a structured Quality System Documentation Model for defining a quality system charter, general operating procedures, standard operation procedures, work instructions and quality system records (see below).
Quality and Regulatory Function
Phase Forward has a dedicated staff of Quality and Regulatory professionals based in both the U.S. and Europe, reporting directly to our President and CEO. Phase Forward’s Quality and Regulatory department is integral to all aspects of the business and is responsible for:
- Monitoring and assessing Quality and Regulatory Compliance throughout the global organization
- Interfacing with departmental managers to develop and implement corrective actions and initiatives throughout the global organization to improve quality and compliance
- Reporting progress and status of quality initiatives to Senior Management
- Creating and implementing Quality System processes and procedures to provide for continuous improvement and compliance to global regulations and company-wide Quality System mandates
- Monitoring and improving training programs throughout the organization
- Performing internal quality audits of various functions throughout the organization
- Addressing and bringing to a close audit findings and corrective actions resulting from customer audits and internal audits
- Performing quality audits of Phase Forward's external suppliers and reporting on findings
- Hosting customer audits and providing responses to customer audit reports
- Reporting to Senior Management on customer audit findings, internal and vendor audit findings, and audit metrics