QAD Life Sciences

1. Computer Systems Validation Practice
Ensure FDA and GMP compliance for your computer systems.
Enterpris e Busine s s S olutions
Overview
Validation is the process of providing documented evidence that equipment, computer systems and processes are installed, operate and
perform as specified providing consistent results. The necessary documented evidence is provided through the development of two primary
groups of documents. They are specification documents and Validation Protocols:
Specification Documents – There are 3 primary specification documents:
1) Functional Requirements Specifications - This is a controlled document defining the
top-level functional business rules and user requirements for each business process
with Quality System or GMP impact.
2) Functional Design Specifications - This is a controlled document defining the configuration
of the system in order to support the business requirements defined in the Functional
Requirements Specification.
3) Data Migration Specifications – This is a controlled document defining the process
E nt e r p ris e B u sin e s s S o lut io n s
and data to be manually or electronically loaded into the new or upgraded system and
Built on QAD® applications, RCM Technologies
how this data will be verified accurate.
provides high quality, cost-effective business
Validation Protocols – These are tests executed during the formal testing phase to validate
solutions and services that enable customers
and/or prove that each requirement can consistently be met and provide consistent results. to meet and exceed their objectives. QAD ®
applications manage the core business
RCM offers three service options for the computer systems validation of the processes of your enterprise, with industry–
QAD ERP System: specific design functionality. As an authorized
Sales and Services Channel Partner of QAD,®
1) PURCHASE 2) TEAM APPROACH 3) TURNKEY APPROACH
RCM leverages the expertise of their staff
The full suite of validation The Team approach utilizes This approach utilizes RCM and proven methodologies to assist clients
documents and protocols a combination of RCM and Staff to perform all validation in implementing QAD ® applications.
are available for sale. The corporate staff. During this activities with a minimal
For almost two decades, RCM has been
validation activities will be process the corporate staff impact on corporate staff.
recognized as a leader in providing QAD®
performed by corporate staff. will gain the knowledge to This approach will require
applications for business solutions. By under-
perform additional validation third part involvement for
standing industry trends, challenges, and
without third party involvement. future validations/re-
issues, RCM extends the capability of QAD ®
The RCM QAD Validation Practice has the knowledge and experience to ensure that your Enterprise Applications and maximizes a
QAD ERP System will be and remain FDA (21 CFR Part 11) and GMP compliant. client’s investment.
(616)284-4790 ­I ­mike.pope@rcmt.com www.rcmt.com

2. Computer Systems Validation Practice
Ensure FDA and GMP compliance for your computer systems.
Enterpris e Busine s s S olutions
North American Channel Alliance
“Partner of the Year”
~ for five consecutive years
RCM has certified consultants that
have documented and mastered the best • Server and Software Installation • Final Validation Report: a report that
Qualifications: a document describing summarizes the activities performed and
training techniques that are now readily
the qualifications and a series of protocols details the validated status of the system.
available to you and your team. RCM that detail the steps required to verify • Instructions for Protocol Execution: a
that the server(s) and software have document detailing specific instructions
will train your organization or perform been properly installed per vendor and on the execution of the protocols, how
validation activities such as: corporate requirement including information changes are to be made and how to
such as climate controlled room, secure record defects.
environment and adhere to vendor
specifications.
1) Validation Project Management
2) Validation Team Building
• Server and Software Operational
Qualifications: a document describing
Contact Us:
the operational qualifications and a 2900 Charlevoix Dr. Suite 100
3) Preparation of all required documents series of protocols designed to verify
including: Grand Rapids, MI 49546
that the server and software operate (616) 284-4790
• Project description: a comprehensive in accordance to vendor and corporate mike.pope@rcmt.com
document describing the validation project. requirements.
• System Validation Master Plan: a • QAD Application Operational
comprehensive document detailing the Qualification: a document describing
validation activities to be completed the application operational qualifications
for the particular hardware and software and a series of functional protocols that
and the plan to meet those activities will provide documented evidence that the
(basically what we are going to do requirement and design specifications are
and how we are going to do it). met and can produce consistent results.
• Functional Requirements Specification: • Data Migration Specifications: a
a comprehensive document detailing document detailing what data is to be
the functional business requirements manually or electronically loaded into
required to ensure the QAD system the new/upgraded system from a legacy
operates as required. system.
• Functional Design Specification: a • Trace Matrix: a document cross
comprehensive document detailing referencing the requirement and design
the design required to ensure the specifications to the individual protocols
functional requirements are met. executed to prove the specification.
(616)284-4790 ­I ­mike.pope@rcmt.com www.rcmt.com