Business Performance Document #: VAL004 ECO #: Effective Date:

Rev: 01
Associates (Company Originator: Business p. 1 of 20
name & logo) Performance Associates

REQUIREMENTS FOR COMPUTER SYSTEM REQUIREMENTS, VALIDATION PLANS,

PROTOCOLS, AND REPORTS

1. PURPOSE
To describe the content requirements for computer system validation plans, protocols, and
reports, including the validation plan for a system, the IQ, OQ and PQ validation protocols,
protocol reports and the Validation Final Report as required by VAL002 or VAL003.

2. SCOPE
This procedure applies to all computer system validation plans, protocols (IQ, OQ, or PQ),
protocol reports, and Validation Final Reports.

3. REFERENCE DOCUMENTS

[Note to the purchaser of this document: The policy documents, procedures, and
templates referenced here are available at www.BPAconsultants.com]

3.1. VAL002 - Validation Requirements for Computer Systems

3.2. VAL003 – Validation of Off-the-Shelf Computer Systems

3.3. VAL005 – Change Control for Validated Systems

3.4. VAL009 – Validation of Spreadsheets

3.5. VAL015 - Guidance - Items to Evaluate in an IQ, OQ, and PQ for a Computer
System

3.6. RISK002 – Risk Management Procedure

3.7. TEMP002 - Validation Plan Template

3.8. TEMP004 – IQ Template

3.9. TEMP005 – OQ Template

3.10. TEMP006 – PQ Template

3.11. TEMP007 –Validation Final Report

3.12. TEMP008 - Computer System Technical Requirements Template

3.13. Stein, R. Timothy. Computer System Risk Management and Validation Life
Cycle. Paton Press, 2006.
4. DEFINITIONS

A license to use this document for internal company use was purchased from Business Performance
Associates, Inc. at www.BPAconsultants.com or ComplianceOnline.com. By the license agreement, the
resale of this document or any modification of it, and the distribution of this document or any modification
of it outside of your company are prohibited. For information contact Tim Stein at
[email protected] , or 408-366-0848. 022006.
 Business Performance Document #: VAL004 ECO #: Effective Date:
Rev: 01
Associates (Company Originator: Business p. 2 of 20
name & logo) Performance Associates

REQUIREMENTS FOR COMPUTER SYSTEM REQUIREMENTS, VALIDATION PLANS,

PROTOCOLS, AND REPORTS

4.1. Acceptance criteria: Standards or requirements specified in the validation plan or

a validation protocol that must be met in order to demonstrate acceptability of the
system.

4.2. Change control: A formal system by which qualified representatives of

appropriate disciplines review proposed or actual changes that might affect a
validated status. The actions that need to be taken during the change process to
ensure that the system is maintained in a validated state are identified and
approved, and documented when completed.

4.3. Computer system: A computer system consists of software components and

associated hardware designed and assembled to perform a specific function or
group of functions. Each computer system is defined in the validation plan
developed for it. Such systems typically include, but may not be limited to:

4.3.1. Hardware dedicated to the system or used by the system.

4.3.2. Operating systems and system software.

4.3.3. Application software.

4.3.4. Data storage devices and software.

4.3.5. Peripheral devices, such as data collection devices and output devices
dedicated to the system.

4.4. Computer System Validation: Confirmation by examination and provision of

objective evidence that the computer system specifications conform to user
needs and intended uses, and that the particular requirements implemented
through the computer system can be consistently fulfilled.

4.5. Installation qualification: Documented verification that all key aspects of

hardware and software installation adhere to appropriate codes and the
computerized system specification, and have been properly installed.

4.6. Operational qualification: Documented verification that a system operates

according to written and preapproved specifications throughout all specified
operating ranges.

4.7. Performance qualification: Documented evidence that the system, process, or

equipment operates within established parameters and performs effectively and
reproducibly under normal production or operational conditions. The products or
results meet their predetermined specifications and quality characteristics.

A license to use this document for internal company use was purchased from Business Performance
Associates, Inc. at www.BPAconsultants.com or ComplianceOnline.com. By the license agreement, the
resale of this document or any modification of it, and the distribution of this document or any modification
of it outside of your company are prohibited. For information contact Tim Stein at
[email protected] , or 408-366-0848. 022006.
 Business Performance Document #: VAL004 ECO #: Effective Date:
Rev: 01
Associates (Company Originator: Business p. 5 of 20
name & logo) Performance Associates

REQUIREMENTS FOR COMPUTER SYSTEM REQUIREMENTS, VALIDATION PLANS,

PROTOCOLS, AND REPORTS

Requirements are the foundation of a validation. Validation involves collecting

objective evidence that the computer system functions reliably to requirements
throughout its operational range. Three types of requirements are defined, as
appropriate: user requirements, technical requirements, and vendor
organizational requirements.

6.1.1. User requirements

User requirements are the requirements for what the system needs to do and
any requirements for how it needs to do it. These requirements are based on the
intended uses of the system. Include the following in the user requirements, as
appropriate:

• System functionality
• Information input and output
• Integrations with other systems
• Performance requirements
• Safety requirements
• Security
• Physical requirements
• Human factor requirements
• Managing legacy data
• Requirements from regulations and standards that are being followed
6.1.2. Technical requirements
Define technical requirements for hardware, system software, application
software and ancillary software, for example for:

• Client workstations
• Servers
• Database
• System integration software
• Communications
• Security
• Network accessibility and availability
• Internet access
• Backup, archive, and recovery
• Information technology service and support

For information on the specific dimensions for which you ought to define
requirements, see TEMP008, Computer System Technical Requirements
Template.

A license to use this document for internal company use was purchased from Business Performance
Associates, Inc. at www.BPAconsultants.com or ComplianceOnline.com. By the license agreement, the
resale of this document or any modification of it, and the distribution of this document or any modification
of it outside of your company are prohibited. For information contact Tim Stein at
[email protected] , or 408-366-0848. 022006.