Drug Safety Validation Services. Life Sciences Solutions for Pharmacovigilance

Transcription

1 Drug Safety Validation Services Life Sciences Solutions for Pharmacovigilance

2 Who We Are 2 HighPoint Solutions is a premier provider of specialized Management and IT services dedicated to the Life Sciences and Healthcare industries. Since 2000, our business consulting and technology solutions have delivered, and continue to deliver, business value and competitive advantage to our clients. 4FY12 revenues of $85 million team members that are globally deployed 4Offices in Philadelphia, Boston, New Jersey, Chicago, Tampa, and Los Angeles

3 Agenda 3 HighPoint s Approach to Validation Overview of Validation Managing Changes to Systems Managing Data Migrations Other PV Services

4 Overview of Validation 4 Need for Validation Internal Compliance: Ensuring a system functions as specified provides a level of quality assurance for a product. Also, external regulators may also require that systems be compliant to a company s internal policies and procedures. External Compliance: In life sciences, many systems support regulated activities and care must be given to comply with all local, state, national and international regulations. Patient Safety: Depending on the system, failure to ensure proper functionality and compliance could directly impact patient safety. Aspects of HighPoint s Validation Methodology Industry Proven: Each phase of a project has specific validation deliverables. There are validation activities that occur in all standard phases: Requirements Gathering, Design, Build, Testing and Deployment. Risk-based: Using a risk-based approach, the validation schedule can be optimized and testing can be targeted to where it is needed. Dynamically Scalable: The effort needed to validate a project scales to the scope of the task. Smaller changes may need only simple testing, but large projects may require a full suite of validation activities and deliverables.

5 Our Approach to Validation 5 Using the V-Model, each requirement and specification are tested. The level of testing is determined based on a functional risk assessment.

6 Create Alignment through Validation 6 Health Authority Regulations Validation creates Alignment Production Environment (system functions as designed) System Documentation

7 Areas of Expertise in PV 7 Continuous Production Support Regulatory-driven Operational Changes When new regulations required updates or additions to an existing system, we reviewed the changes and developed a testing strategy to ensure compliance was maintained and that existing business functions remained intact. Optimization of Business Processing In responding to organization restructuring, we were able to validate changes to an entire case processing workflow from registration through reporting and ensure that all required data was on the reports submitted to regulatory authorities. Implementation of New Components to PV System We have developed validation testing for the installation of new Inbound case registration components, Metrics packages with integrated CAPA workflows and Electronic document repository systems.

8 Areas of Expertise in PV 8 Data Migration Projects Medical Product Purchase (Migration of Data Subset) When a new product was acquired, we validated a data migration that combined a split of case data from E2B submission records and a manual extract from the source environment into a target environment with field-to-field mapping, workflow and reporting verifications. Entity Acquisition (Full System Migration) When a company was migrating data from ARGUS and ARISg at two separate companies into its existing AERS system, we validated changes to the configuration of the target system to support the processing of device and vaccine records. We then performed field-to-field mapping, workflow and reporting verifications to ensure business continuity remained intact across the three organizations.

9 Questions? 9 Get ready. Here are the answers you re looking for.