1. RCM Technologies (NASDAQ: RCMT) is a premier provider of business and technology solutions. These solutions are uniquely designed to enhance and
maximize the operational performance of customers by adapting and deploying advanced information technology and engineering services. For over 35
years RCM has been an innovative leader in the design, development and delivery of these solutions to commercial and government sectors. With offices
throughout North America and the capacity to delivery globally, RCM offers its customers solutions on a national and international scale.
Background
On March 10, 2011, FDA announced that a
consent decree of permanent injunction
has been filed against a subsidiary of a
Fortune 100 pharmaceutical and medical
device company, for failing to comply with
current good manufacturing practice
requirements. The action prevented that
portion of the company from
manufacturing and distributing drugs from
its PA facility until the FDA determines that
its operations are compliant with the law.
In response to the consent decree, the
company had the need to re-assess the
compliant and validated state of the
computerized system used to support the
product Quality Assurance processes and
implement remediation of any resulting
findings.
The project consisted of two phases: (1) the
initial assessment of the system validation
and compliance documentation; and (2)
major system remediation release to
address the assessment findings.
Goals
Assessment phase
 Assess, document and
communicate the current system
compliance state, identify findings
and remediation action.
Remediation phase
 Validate implementation of a major
system release in conjunction with
significant business process
changes.
 Define and implement high Quality
Assurance standards demanded by
Consent Decree environment.
 Meet deadlines established in
cooperation with FDA.
Approach
A team of senior RCM SMEs executed
the system compliance assessment six
weeks ahead of schedule and under
budget, providing the client with clear
findings and remediation strategy.
RCM formed two teams that engaged
on project System Validation and
Quality Assurance activities. RCM
developed and implemented a
solution-oriented “Center of
Excellence” approach to the project,
successfully providing vastly qualified
personnel and maintaining high-
productivity project environment.
Benefits
Expertise
 RCM provided industry experts to
support both Systems Validation
and Quality Assurance initiatives
Quality and Consistency
 RCM defined and implemented
project-specific candidate selection
and qualification criteria
Immediate Productivity
 RCM provided pre-training on
relevant client SOPs, on-site
mentoring, leadership, orientation
and support, etc.
Personnel Retention
 RCM implemented retention
initiatives and motivators
 RCM provided dedicated on-site
management presence
Cultural Alignment
 RCM exemplified consistent
positive project culture
Contact:
Laura DeLea- Account Executive
201-400-9774
Case Study
Consent Decree Remediation Project
Computer Systems Validation and Quality Assurance
RCM’s mission is to be in a
leadership position in its
industry by providing
responsive, high-quality,
reliable, technologically
advanced, and cost-effective
services that enable its
customers to meet their
business objectives