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 6, 2002, the FDA announced that
a consent decree of permanent injunction
had been filed against one of the nation’s
top pharmaceutical corporations for failing
to comply with numerous FDA regulations.
In addition to a $500 million fine, the
consent decree halted the company’s
production of 73 human and veterinary
products and mandated the recall of two of
the company’s core medications.
In response to the consent decree, the
company needed to assess the compliant
state of its computerized systems, Excel
spreadsheets and databases used to
support stand-alone laboratory systems.
All assessment finding needed to be
documented and appropriately addressed.
The client requested RCM to provide both
managerial oversight and the delivery
personnel to complete required activities.
Goals
Assessment phase
 Assess, document and
communicate the current
compliance state of 50+ stand-
alone laboratory systems and
supporting spreadsheets and
databases. Identify compliance
gaps and remediation action.
Remediation phase
 Ensure full 21 CFR Part 11
compliance for regulated systems.
 Based on the assessment findings
risk rating, implement required
scaled computerized systems
validation efforts.
 Implement and document
retirement of 100+ systems.
Approach
RCM enlisted and managed a highly
effective team of 28 Validation and 21
CFR Part 11 technical experts.
The team was responsible for:
 Executing and documenting the
regulatory assessment of the
systems in scope and identifying
the gaps and remediation
activities.
 Defining and implementing a Part
11 compliance strategy. The
implemented solutions included
system upgrades to later versions
and the implementation of a third
part “wrapper” system that
ensured Part 11 compliance.
 Generating a full suite of validation
documents for 50+ systems.
 Implementing purely procedural
remediation for 15+ systems.
 Implementing and documenting
the retirement of 100+ systems.
 Documenting and transferring the
knowledge needed to support the
validated system environment.
Benefits
 RCM met the project compliance,
quality, and delivery goals within
the allocated aggressive time lines.
 RCM remediated the client’s Part
11 compliance and validation state
and implemented next-generation
technology solutions.
 RCM generated and transferred
standards, creating a roadmap for
effective and sustainable
compliance.
 RCM generated and transferred to
the client standards for effective
and sustainable compliance.
 RCM remains a trusted advisor and
partner in effective and compliant
ongoing execution to this day.
Case Study
Consent Decree Remediation Project
21 CFR Part 11 Compliance
Computerized Systems Validation
RCM’s mission is to be a
trusted advisor and partner in
execution by providing
responsive, high-quality,
reliable, technologically
advanced, and cost-effective
services that enable its
customers to meet complex
business objectives