Regulatory Compliance Case Studies

Background The corporation was operating numerous manufacturing, distribution, and sales operations throughout the world.

Business Issue A patchwork of business systems was preventing a faster penetration of new markets and was constraining profitability.

The Objective Establish a corporate computer system quality policy and related procedures to ensure validation and compliance across the corporation.

The Solution The corporate-driven ERP implementation centered on establishing a standard ERP configuration for the corporation. This configuration would then be rolled out to each site. Arbour Group was responsible for assisting with validating this system at each site. Working with the client's worldwide implementation team, Arbour Group first developed a validation package for the client's standard ERP package configuration. This package included:

• Validation Plan
• User Requirements Specification
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Requirements Traceability Matrix
• Validation Summary Report

Each site received a CD containing this validation package. As the ERP system was rolled out at each site, Arbour Group performed validation training for site personnel. These sessions were comprised of both GMP awareness training and detailed computer validation training. In reviewing the baseline validation package, each site was instructed to perform additional hardware validation testing for locally developed reports and configuration changes. Arbour Group provided follow-up technical assistance to support each site with validation.

Background A Fortune 100 pharmaceutical company divested its infant formula division. Under local management ownership, the new company was required to deploy a new ERP system to replace the legacy corporate system.

Business Issue The new company selected a major enterprise software package for its manufacturing, distribution and financial system. Management was under a tight deadline to implement this ERP system because of signed divestiture agreements made with the former parent company. The strict regulatory environment on infant nutritional products made it imperative that this system be validated and that it comply with FDA-enforced regulations, including Part 11 Electronic Records & Electronic Signatures.

The Objective Implement and deploy a validated ERP system within 5 months.

The Solution Arbour Group worked closely with senior management and the project team leaders to validate the enterprise software prior to its deployment in production. Following the implementation model (project preparation, business blueprint, realization, final preparation), Arbour Group successfully validated the software system. Validation deliverables consisted of:

• Validation Plan
• User Requirements
• Functional Specifications
• Platform IQOQ Protocol
• Application IQOQ Protocol
• System PQ Protocol
• Validation Trace Matrix
• Validation Summary Report

Arbour Group engaged effectively with the implementation team and worked to minimize the impact on exiting project resources. Specifications for the GMP functions were defined utilizing the business blueprint documentation. Validation test documentation was developed utilizing Arbour Group's test libraries along with business process procedures developed by the implementation team.

Background A $4 billion generic pharmaceutical company recently acquired an Eastern European pharmaceutical company. The business plan for this newly acquired business unit is to aggressively expand sales into European Union markets.

Business Issue Executive management recognized that a new ERP system needed to be deployed at this acquired site to support the anticipated increase in business volume and complex supply chain model. Moreover, the corporation mandated that this system be validated to meet U.S. and E.U. regulatory requirements currently followed at other company locations.

The Objective Implement a validated ERP system to meet regulatory approval.

The Solution Arbour Group deployed consulting resources from its Dublin, Ireland and Dubai, United Arab Emirates offices for this project to work on site with senior management and the project team leaders to validate the enterprise system. Working aside the implementation team, Arbour Group successfully validated the software system. Validation deliverables consisted of:

• Validation Plan
• User Requirements
• Product/Patient Safety Risk Assessment
• Functional Specifications
• Platform IQOQ Protocol
• Application IQOQ Protocol
• System PQ Protocol
• Validation Trace Matrix
• Validation Summary Report

This project was the first computer validation effort for this site. Arbour Group worked closely with client personnel to train and mentor local resources throughout the project.

Background The company had experienced rapid growth in recent years. This growth required the manufacturer to significantly expand its facilities and substantially improve its business systems to support this increased level of business

Business Issue Senior management anticipated increased regulatory scrutiny associated with these new product approvals and the expansion in manufacturing capability.

The Objective Implement a scalable ERP system in compliance with QSR regulations.

The Solution Arbour Group deployed its consulting resources that worked in conjunction with the implementation partner to design regulatory grade business practices to support its growth. These practices were manifested in the application configuration and successfully validated. Validation deliverables consisted of:

• Validation Plan
• User Requirements
• Product/Patient Safety Risk Assessment
• Functional Specifications
• Platform IQOQ Protocol
• Application IQOQ Protocol
• System PQ Protocol
• Validation Trace Matrix
• Validation Summary Report

This project allowed the company to lower its regulatory risk, and avoid any costly interruption in business, all the while continuing its torrid expansion.

Background The company had experienced substantial growth through the acquisition of numerous medical device and pharmaceutical operations over the previous ten years.

Business Issue With a large diversity in medical products and services and a global presence, the company had encountered increased regulatory pressure and organizational challenges for managing computer technology.

The Objective Establish a corporate computer system quality policy and related procedures to ensure compliance across the corporation.

The Solution Along with the company's executive management, Arbour Group defined a quality system architecture. Working with quality compliance, IT and major system owners (e.g., QC laboratory, engineering, R&D, manufacturing and quality control), Arbour Group developed a computer system master compliance plan and the following corporate policies and procedures:

• Computer Validation Policy
• Special Uses Policy
• Legacy System Remediation Procedure
• New System Implementation and Validation
• Quality System Change Control
• Network Configuration and Change Control

The master compliance plan identified corporate expectations for implementing a divisional rollout of this quality system. Major components included training (overview and skills-based), technical assistance, quarterly progress reporting and compliance monitoring.

Background The division had experienced rapid growth in recent years. This growth required the division to significantly expand its facilities and substantially increase automation to support this increased level of business.

Business Issue Senior management anticipated increased regulatory scrutiny associated with the expansion in manufacturing, especially in light of recent FDA requirements regarding electronic records and signatures.

The Objective The division had to develop a computer system master plan and begin bringing its systems into compliance. All high priority legacy systems and new systems supporting the expansion had to be compliant within one year.

The Solution Arbour Group worked with the company's senior management to inventory systems, assess risk, assess compliance gaps and develop a Part 11 remediation plan. This plan identified time frames for bringing high-, medium- and low-risk systems into compliance. Arbour Group experts then worked with the client's Part 11 remediation group to rectify selected high priority systems.

Background This not-for-profit organization represents more than 6,200 surgeons, researchers and allied health care professionals worldwide who are dedicated to ensuring the best possible outcomes for surgeries of the heart, lung, and esophagus, as well as other surgical procedures within the chest.

Business Issue The organization maintains a registry of patient outcomes that is incorporated into various application software solutions to assist clinical sites in addressing many areas of surgical and interventional vascular medicine. A certification program is required to ensure that the vendor applications properly utilize this registry information for maintenance, inquiry and reporting purposes.

The Objective Implement a vendor software certification program specific to this health registry.

The Solution Starting with a detailed data specification, Arbour Group constructed a comprehensive testing regimen that was implemented for each vendor solution. This package included:

• Audit Test Plan: Described the overall approach to testing, including data element and software function testing
• Audit Manuals: The specific test protocols to verify the following:
• General features
• Record management
• Data entry
• Field dependencies
• Data quality and completeness checks
• Data import
• Record subsets and queries
• Reporting
• Data export for analysis by user
• Data harvest
• On-demand updates
• Test Data Sets: Specific data used to prove test outcomes
• Audit Reports: Actual results of testing, including any software non- conformances