Online Store: Computer System Validation, Risk Management, and IT
Computer System Validation Procedures
Computer System Validation Based on Risk – Gain Efficiencies
Computer System Validation Procedures
| Procedure Title | Description | Price |
VAL001 Validation Policy (RiskValSM) |
Members of regulated companies are often confused about what needs to be validated when. This document sets the validation policy for your company. It identifies when equipment, processes, and computer systems need to be validated at the research, development, clinical, and commercial phases of the product lifecycle. 9 pages |
$99.00 |
VAL002 Validation Requirements for Types of Computer Systems (RiskValSM) |
This procedure interprets the general validation policy for different types of computer systems. It defines high-level requirements for the validation of operating systems, firmware (e.g., instruments), commercial off-the-shelf packages, configured applications, custom software, and mixed systems. Deliverables that are common across the types of systems are described. 14 pages |
$99.00 |
VAL003a Validation of Computer Systems Used in Production and Quality Systems (RiskValSM) |
This
procedure defines the process for the validation of off-the-shelf
and configured computer systems. Deliverables are clear defined.
It is a practical guide for the validation of high-, moderate- and
low-risk systems to meet FDA's requirements and ISO 13485. In addition,
the procedure includes practices to manage the risks associated
with computer system failures. This procedure is based on the RiskVal
Life Cycle described in Computer
System Risk Management and Validation Life Cycle
(Paton Professional, 2006). 26 pages
|
$49.00 |
VAL003b Life Cycle for the Selection, Implementation, Validation and Use of Computer Systems (RiskValSM Life Cycle) |
This
procedure defines the requirements for the validation of off-the-shelf
and configured computer systems. It takes a life cycle approach
that spans from the initial need for a system through requirements
development, systems selection, system implementation and risk mitigation,
validation testing, system use, and retirement. This life cycle,
called RiskVal is described in detail in Computer
System Risk Management and Validation Life Cycle
(Paton Professional, 2006). It is a practical guide for the validation
of high-, moderate- and low-risk systems to meet FDA's requirements
and ISO 13485. 32 pages
|
$49.00 |
VAL004 Requirements for Computer System Requirements, Validation Plans, Protocols and Reports (RiskValSM) |
This procedure provides detailed outlines of what needs to be included in the most important computer system validation deliverables, including requirements, validation plans, IQ, OQ and PQ protocols, protocol reports, and the validation final report. This procedure is of great value to those who are not familiar with these types of documents and those who want to verify that what they are including in their documents is what auditors look for. 20 pages |
$99.00 |
VAL019 Guidance on Validation Activities for Systems at the Low-, Moderate-, and High-Risk Levels (RiskValSM) |
Being able to cut back on the validation deliverables needed, and what is included in the deliverables is a major way to gain efficiencies in the validation process. This guidance document speaks to when a validation deliverable is needed for high, moderate, and low risk systems. It also addresses the level of rigor and intensity of the validation activities that are appropriate for systems at the 3 risk levels. The FDA recommends that the validation of the system be commensurate with the risk associated with the system. 9 pages |
$150.00 |
VAL005 Change Control for Validated Systems (RiskValSM) |
Once a computer system is validated, it must be placed under change control. The FDA and ISO 13485 require that changes to validated computer systems be approved in advance. The change and the system must be appropriately tested to ensure that the change is effective and that it hasn't inadvertently negatively impacted the system's ability to meet requirements. This document describes a practical change control process and provides an approval form. 17 pages | $125.00 |
|
VAL007 Computer Vendor Qualification and Management (RiskValSM)
|
Vendor qualification is required by the FDA and ISO 13485. The vendor
qualification of most companies is centered on first article inspection
of parts. In contrast, this procedure answers the question: How do
I qualify software and hardware vendors? The procedure describes the
requirements and process for the qualification and management of vendors
who provide system software, application software, computer hardware,
support services, or software development or integration services.
8 pages
|
$125.00 |
VAL008 Computer System Vendor Audit Checklist (RiskValSM) |
Poorly developed software could have ten times as many defects as well engineered software. As with other products, quality has to be built in. If the software is of poor quality, validation testing is not going to make it function properly. This checklist is a form for conducting an on-site audit of a software vendor's quality system, and software development and support processes. It can be used to determine if the vendor has built the software you intend to purchase with the software development practices associated with quality software and recommended in the FDA guidance document on computer system validation. 44 pages | $195.00 |
| VAL015 Guidance - Items to Evaluate in an IQ, OQ, or PQ for a Computer System (RiskValSM) | One of the difficult questions, especially for the first several validations, is what do I need to test in each of my IQ, OQ, and PQ protocols. This document explains 15 types of items that may need to be tested in one or more of the protocols for a system. In addition, it explains 11 types of testing that can be used for each dimension. While using test data is the most common type of testing, one of the other options may be better suited to your system or the context in which it is used. 13 pages |
$99.00 |
VAL006 Computer System Project Proposal (RiskValSM) |
Departments or individuals often bring applications into the company, or build their own using software like Access. Two types of problems result: the company is out of compliance because QA was not told and the system was not validated. In addition, the need to support a new system is sprung on IT. This procedure provides a computer system project proposal form and instructions. The form is used to assess if validation is required and the IT support needs before a new system is purchased or created. It also provides an early view into computer system implementations so that the organization can plan for the needed resources. 9 pages |
$99.00 |
VAL018 Validation Master Plan Item Information Form (RiskValSM) |
The Validation
Master Plan Item Information Form plays a critical role in the development
of a master plan. The form is used to collect information about each
of the computer systems that are in use that may need to be validated.
Based on the form, the team creating the validation master plan determines
if the system needs to be validated and its priority. Here the term
“Validation Master Plan” refers to a plan for the validation
of all computerized systems at a facility. 7 pages |
$99.00 |
| Procedure Title | Description | Price |
| MIS001 IT Policy (RiskValSM) | Part 11 requires certain IT policies regarding electronic records and electronic signatures. This policy document includes the IT policies needed in most companies, including those needed to meet Part 11 requirements and to protect validated computer systems from unauthorized intentional and unintentional change. This policy covers the practices for the procurement, support, and use of computer systems needed to ensure their efficacy, reliability, and security. 10 pages | $99.00 |
| Procedure Title | Description | Price |
| RISK001 Risk Management (RiskValSM) |
ISO 14971 requires a policy for the management of risk. This policy document meets this requirement; it defines risk principles and establishes a policy for when formal risk management is required. This policy is the basic corporate policy for the management of risk associated with products (under development and in the market), manufacturing processes, equipment, computer systems, product distribution, etc. Requirements are defined for what needs to be included in the risk management process. 5 pages |
$99.00 |
RISK002 Risk Management Procedure |
This procedure defines a method for risk management that is applicable to formal risk management efforts. The procedure closely follows ISO 14971, and includes risk management planning, risk analysis, risk evaluation, risk control, overall residual risk evaluation, and post-production risk management. This is a generic risk management procedure. For risk management of computer systems, see RISK006. 16 pages |
$99.00 |
RISK003 Failure Mode and Effect Analysis (FMEA) |
The FMEA procedure defines a process for conducting a Failure Mode and Effect Analysis and a form for recording the risk evaluation. This is a general procedure that can be used to perform FMEA analysis on a wide range of items. 8 pages |
$99.00 |
RISK004 Fault-Tree Analysis (FTA) |
This procedure defines a process for conducting a Fault-tree analysis. 7 pages |
$99.00 |
RISK005 Hazard Analysis and Critical Control Point Assessment (HACCP) |
This procedure defines a process for conducting a Hazard Analysis and Critical Control Point assessment (HACCP). 9 pages |
$99.00 |
RISK006 Computer System Risk Evaluation for Determining Risk Mitigations, Validation Activities, and the Extent of Testing (RiskValSM) |
This procedure defines a method for determining the system risk level and the risk levels associated with failures of a computer system to meet requirements. These analyses are the basis for risk based adjustments to the validation of computer systems. This procedure adapts the risk management standard (ISO 14971) to computer systems. A methodology for a high-level risk analysis is used to determine the risk level of a computer system. The system risk level is used to determine the validation activities and the rigor and intensity of those activities. A detailed risk evaluation is also presented for determining the risks associated with the failure of the computer system to meet specific requirements. The results of the detailed analysis are used to mitigate risks, and to determine the level of testing that ought to be done on the ability of the system to meet each requirement. This analysis can result in a large reduction in the testing that needs to be done for a validation. |
$150.00 |
| Procedure Title | Description | Price |
| TEMP001 Validation Master Plan Template | Companies who have a number of computer systems and are just starting to validate them need to determine what really needs to be validated and the priorities for the validation. Everything cannot be done at the same time; a plan for validation and achieving Part 11 compliance is needed. This template describes the information that needs to be presented in a validation master plan and provides examples. 9 pages | $99.00 |
| TEMP002 Validation Plan Template for Single System Validations (RiskValSM) | The validation plan for a system is the definitive document on what will be done for the validation of that system. It provides the logic and justification for the validation approach. It also establishes acceptance criteria for evaluating if the system is suitable for use. It identifies, based on the system risk level, the validation activities that will be performed and the level of rigor and intensity to be applied. This template provides extensive instructions for and examples of each section of a validation plan. 20 pages | $99.00 |
| TEMP008 Computer System Technical Requirements Template (RiskValSM) | The technical requirements template provides extensive instructions and examples for creating technical requirements for a computer system. The example requirements given for 9 types of items can easily be modified, making the preparation of the technical requirements for your system quick and easy. The technical requirements are used in the selection of the system and the system specification. 7 pages | $99.00 |
| TEMP009 Computer System Specification Template (RiskValSM) | The system specification documents the technical requirements for the system and its configuration prior to installation in the test environment and conducting the IQ. This template provides instructions and examples on how to document the existing hardware and software platform and the configuration of a computer system. The system specification is used as the basis for the IQ, for detailed documentation of the system as validated, and as the blueprint for rebuilding the system in case of a need to replicate or restore the system as validated. 9 pages | $99.00 |
| TEMP004 Computer System IQ Template (RiskValSM) | This IQ template provides extensive instructions on how to create an Installation Qualification (IQ) protocol for a computer system. It includes examples of items to verify for 15 different types of hardware and software. The general format for the IQ protocol is also applicable for IQs for other types of items, such as equipment, facilities and utilities. 27 pages | $99.00 |
| TEMP005 Computer System OQ Template (RiskVal) | This OQ template provides extensive examples and instructions on how to create an Operational Qualification (OQ) for a computer system. The general format for the OQ protocol is also applicable for OQs for other types of items, such as equipment, facilities and utilities. 27 pages | $99.00 |
| TEMP006 Computer System PQ Template (RiskValSM) | This PQ template provides extensive examples and instructions on how to create a Performance Qualification (PQ) protocol for the validation of a specific computer system. The general format for the PQ protocol is also applicable for PQs for other types of items, such as equipment, facilities and utilities. 29 pages | $99.00 |
| TEMP007 Validation Final Report Template (RiskValSM) | This template provides extensive instructions and examples for creating a validation report for a specific computer system or piece of equipment. The final report reviews the results of the validation activities and draws conclusions as to (1) whether or not the risks associated with system failure have been reduced to an acceptable level and (2) if the system functions reliably to requirements. 14 pages | $99.00 |
Special Packages
Packages have a 10% discount off the individual prices of these documents
Computer System Validation Based on Risk – Gain Efficiencies
A risk-based approach to computer system validation will save time and money. These three documents provide what is needed to implement a risk-based approach. The package includes a validation procedure, a method for determining risk levels for the system and requirements, and guidelines on how to modify the validation process based on risk.
The package price is $265 compared to the list price total of $298. Buy Now!
| Validation Based on Risk | |
| VAL003b | Life Cycle for the Selection, Implementation, Validation and Use of Off-the-Shelf Computer Systems |
| RISK006 | Computer System Risk Evaluation for Determining Risk Mitigations, Validation Activities, and the Extent of Testing |
| VAL019 | Guidance on Validation Activities for Systems at the Low-, Moderate-, and High-Risk Levels |
Computer System Validation Basic Procedures and Templates
This package of 17 documents provides the procedures needed for computer system validation, and templates that provide examples and detailed instructions on how to create the deliverables. This package defines what you need to do, how to do it, and provides time saving templates for consistent, compliant validations. The package includes the three items in the “Computer System Validation Based on Risk” package.
The package price is $1,600 compared to the list price total of $1,787. Buy Now!
| Computer System Validation Basics | |
| VAL001 | Validation Policy |
| VAL003b | Life Cycle for the Selection, Implementation, Validation and Use of Off-the-Shelf Computer Systems |
| VAL004 | Requirements for Computer System Requirements, Validation Plans, Protocols and Reports |
| VAL005 | Change Control for Validated Systems |
| VAL006 | Computer System Project Proposal |
| VAL007 | Computer System Vendor Qualification and Management |
| VAL015 | Guidance - Items to Evaluate in an IQ, OQ, and PQ for a Computer System |
| VAL019 | Guidance - Validation Activities for Systems at the Low-, Moderate-, and High-Risk Levels |
| TEMP002 | Validation Plan Template for Single Validations |
| TEMP004 | Computer System IQ Template |
| TEMP005 | Computer System OQ Template |
| TEMP006 | Computer System PQ Template |
| TEMP007 | Validation Final Report Template |
| TEMP008 | Computer System Technical Requirements Template |
| TEMP009 | Computer System Specification Template |
| RISK006 | Computer System Risk Evaluation for Determining Risk Mitigations, Validation Activities, and the Extent of Testing |
| MIS001 | IT Policy |
| Procedure Title | Description | Price |
| BL Special License | BL Special License | $1286.90 |
Call Tim Stein at 408-366-0848
