Patni helps leading biopharmaceutical validate its ARISg safety system as per regulatory compliance requirements.
The Client
The client is one of the top ten biopharmaceutical companies in the world with nine proprietary products in the US, and more than double that many around the world. It is a company with first-in-class therapeutic, a rich oncology research pipeline and medications to treat central nervous system disorders, cancer, pain and addiction. The company has a deep and diverse pipeline and annual revenues of over US $1.77 billion.
The Challenge
The client was aggressively pursuing the implementation of ARISg as its enterprise application/database for drug safety and Pharmacovigilance data management and reporting. In order to release the final ARISg configuration into the production environment, the client required an experienced business partner who could produce the validation deliverables necessary to support the production release of the system.
The objective of the engagement was to produce a defensible validation package that can support the release of ARISg to an FDS regulated production environment. The client needed assurance that quality would be maintained throughout the ARISg implementation process and that the targeted workflows would consistently provide the functionality necessary to meet the needs defined for users.
The client considered Patni's extensive domain knowledge in Pharmacovigilance and Regulatory Compliance and contracted us to expedite the validation of the ARISg implementation and meet aggressive timelines.
The Solution
The client selected Patni as its safety system validation partner to accelerate the creation of a defensible validation package for the ARISg safety system. Patni Life Sciences (PLS) team overcame several crippling challenges to complete the assignment. The ARISg product implemented by the client was new to the PLS team. In addition to this, the client's business requirements like data entry guidelines and configuration specs changed at frequent intervals. The PLS offshore team also faced delays in availability of remote connectivity and system set-up in the client's environment, and non-availability of remote access to PLS onshore resources.
Patni quickly ramped-up on the ARISg product and gained process knowledge, and over the duration of the engagement, produced the validation deliverable required for meeting FDA guidance for computer systems validation. The scope of the implementation was the core ARISg configuration with 100 percent of case handling performed at the client's site in the US.
PLS produced the following deliverables:
Validation Plan & Project Schedule
User Requirements Specification
Risk Assessment
IQ, QQ Plan and scripts
Executed IQ, QQ scripts (test and validation environment)
IQ, QQ Summary Reports (test and validation environment)
PQ Plan and scripts
PQ Summary Report
Validation Summary Report
System Release Memo
Prior to the client's pre-execution script approval and the final execution phase, PLS performed a 'dry run' of all scripts. PLS also supported the execution of test scripts by the client in the production environment.
Key Enablers
Effective project management - Risk Management, progress monitoring, resource planning and utilization, effective communication and team coordination, project planning
Global Delivery Model - Faster turnaround times due to team members located across different time zones
Institutionalization of activities like Defect Prevention, Lessons Learnt and reviews and evaluation established mechanism for continuous improvement
Key Best Practices
PLS templates used for Test Script creation, Print Screen documents and Variance reporting
Effective modularisation of test scripts to discover maximum defects in the first cycle of testing
Tracking testing coverage of various business functionalities by maintaining a Requirement Traceability Matrix
The Benefits
The client's QA representative reviewed the executed QQ scripts and commended the great job done in writing and executing the scripts, opening the variances, annotating attachments, and conducting the post-execution reviews. Key benefits accrued by the client include:
Independent Verification & Validation viewpoint: PLS team comprising validation and testing experts and healthcare professionals ensured compliance to Pharmacovigilance and regulatory requirements
High Quality defensible validation package: Detailed test scripts ensured appropriate coverage of functionality as per business needs and expected performance of ARISg application as per client's configuration
Test scripts and documentation adhering to Good Documentation Practices (GDP): High quality test scripts developed by adhering to GDP ensured minimal ambiguity to testers during actual execution thereby accelerating the formal execution phase
Cost-effective Execution: Project was executed within budget
First-time-right delivery: OQ script formal execution and post execution approval documents were reviewed and approved by client's QA representative without requiring any updates, corrections to annotations. Quality of work was appreciated by client
Global Delivery Model benefits:
The Technology