Why Validate?

Software validation is a requirement of regulatory agencies, including, but not limited to, the United State Food and Drug Administration (FDA).  All blood establishment computer software, including SafeTrace Tx, must be validated for its intended use.

Completion of a successful validation will serve as testimony that the system is compliant with needs and expectations of the organization. 

In the realm of blood establishment computer software, validation determines whether the system and its setup meet the needs of the organization. 

Software may not meet needs of users which it was not required to support.  Validation can identify gaps between user needs and software requirements where external process may need to be implemented.

What Validation is Not

What Should My Validation Objectives Be?

What is Validation?
Validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes.  FDA considers software validation to be confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses and that requirements implemented through software can be consistently fulfilled.  Validation is also confirmation by examination and provision of objective evidence that particular requirements for the software intended uses can be consistently fulfilled.  Validation of blood establishment computer software in the user facility assures that the software is suitable for user specific operations and workload, and that it can accurately and repeatedly meet user needs as defined in requirements documentation.

What is Process Validation?
Process validation consists of three elements, installation qualification, operational qualification and performance qualification.  Installation qualification is accomplished when the software is installed on hardware according to specifications defined in the user labeling documentation.  Installation qualification is further challenged as operational and performance qualification tests are performed to validation the system in the user environment.

What is a Test Procedure?
A test procedure, also known as a test case, is a discrete set of steps which challenge a particular area of the system.  Test procedures include documentation of the objective to be accomplished, data setup requirements, the scenario or steps to execute the test, the anticipated or expected outcome, and the actual outcome of the test.

What is Risk Analysis?
Risk analysis is a systematic evaluation of functions and features of the software and SOPs which have potential to cause harm if they were to malfunction, fail, or otherwise not perform as expected.  Risk analysis consists of three elements, risk assessment (identifying sources of potential harm, assessing the likelihood that harm will occur), risk management (evaluating which risks from the risk assessment require management and selecting/implementing plans or actions to ensure that those risks are controlled), and risk communication (documenting and informing stakeholders).

Risk assessment is performed as part of the software design lifecycle process.  Validation testing is one component of risk management and this validation plan is the risk communication for validation risk management activities.

What is a Test Objective?
Each test procedure will contain a discrete objective, or goal for the outcome to be accomplished by exercising the test case.  Test cases which exercise features and functions with potential risk will have their objective cross-referenced as part of risk analysis.

What is 21CFR210 and 21CFR211?
21CFR210 = Code of Federal Regulations, Title 21 - Food and Drugs. Part 210 - - Current Good Manufacturing Practice In Manufacturing, Processing, Packing, Or Holding Of Drugs; General
21CFR211 = Code of Federal Regulations, Title 21 - Food and Drugs. Part 211 -  - Current Good Manufacturing Practice For Finished Pharmaceuticals

How Long Does Validation Take?
System validation testing will be conducted at the time defined in the implementation project plan.  Generally, validation commences after most of the implementation steps are complete but immediately prior to go-live use of the system in production. 

The amount of time required to complete end user system validation varies greatly, but depends primarily on the complexity of the system configuration, the quality and detail of the Standard Operating Policies and Procedures (SOPs) and the number of resources dedicated to the validation effort.  In general validation requires a minimum of eight person weeks of effort.  Some validations may require twelve weeks of activity and a few may require longer than twelve weeks to complete.

Is Validation Cost-Effective?
Despite the initial costs of hiring a validation company, return on investment may be greater than attempting a validation process in-house.   If existing staff are not proficient in the validation process, steps may be missed, causing ineffective use of the software later; staff hours may be better utilized on other tasks; an inexperienced staff may take longer to validate than a validation consultant, causing a longer implementation.

Is Validation done on-site or remotely?
Validation can be done on-site or remotely.

Is it permissible to use third party validation vendors?
Although the responsibility for validating software ultimately rests on the user, the FDA has no regulations against using third party vendors for software validation.

What are the advantages of using a third party vendor?
Third party validation specialists are specially trained in the software and in validation processes, in most cases completing the validation in less time with more accuracy than inside staff . 

Validation consultants can save time in the planning and training stages because they are aware of the many intricacies and limitations of the system they are validating.

Using a third party validation vendor assures a quality validation process and frees internal staff to continue with daily operations. 

Third party validation specialists may be more neutral and less invested in the internal politics, personalities, and budget issues than in-house staff, allowing them to address issues without fear of reprisals.

Are all validation vendors alike?
No, all validation vendors are not alike. Many validation companies offer “off-the-shelf” packages which are generic at best.  Although the core processes in these ready-made packages are generally sound, they may miss specific process requirements of individual facilities.

PeopleMed takes into consideration the myriad of differences between organizations and offers blood centers and hospitals individual solutions for their validation needs, ensuring that the system and its setup meet the needs of the organization.