Verification activities

Have adequate resources been provided for management, performance of work, and verification activities ... 

Have the personnel assigned to management, operational, and verification activities been properly trained ... 

The standard requires the supplier to provide appropriate technical resources for tool and gage design, fabrication, and verification activities, establish a system for tooling management, and implement a system to tack and follow-up tooling management activities if any work is subcontracted. 

The standard requires that the design and verification activities he assigned to qualified personnel equipped with adequate resources. 

A schedule of design reviews should be established for each product/service being developed. In some cases there will need to be only one design review after completion of all design verification activities. However, depending on the complexity of the design... 

The standard creates a distinction between design verification and design validation. There are two types of verification those verification activities performed during design and on the component parts to verify conformance to specification and those verification activities performed on the completed design to verify performance but more on this later. 

Definition of the verification activities that are to be performed to qualify or validate the design and those which need to be performed on every product in production as a means of ensuring that the qualified design standard has been maintained. 

Definition of the test equipment, support equipment, and facilities needed to carry out the verification activities. 

Definition of the time-scales for the verification activities in the sequence in which the activities are to be carried out. 

Identification of the organization responsible for conducting each of the verification activities. 

The verification plan should be approved by the designers and those performing the verification activities. Following approval the document should be brought under document control. Design verification is often a very costly activity and so any changes in the... 

Prepare procedures for the conduct of design verification activities. 

Do provide a means of tracing the results of verification activities to the characteristics specified in the product specification. 

Do schedule verification activities so as to detect nonconformities as early as possible. 

The total number of declared sites (5947) which are to be regularly or randomly inspected shows the high burden of expected verification activities. At this stage of implementation, the verification activities have been obviously concentrated on storage and destruction, and in industry on facilities producing scheduled chemicals. The number of inspections totalled 1936 at 784 sites in 67 countries till December 10, 2004. 

Guidances recommend an integration of software life-cycle management and risk management activities. Software validation and verification activities must be conducted throughout the software life cycle [12,14]. Software verification and validation are terms frequently confused. Software verification is defined as the process that provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase... 

Software verification consists of tasks performed to evaluate if the software is performing desired tasks and providing desirable results. Software verification is part of software validation. Software testing is one of the many verification activities intended to confirm that software development output meets its input requirements. Other verification activities include various static and dynamic analyses, code and document inspections, walkthroughs, and other techniques [14]. 

For verification activities, the organization critically follows the requirements specified for the competence, awareness, and training for personnel performing quality-related work who may affect the end results. The actions taken are reviewed for their effectiveness. 

Design, development, and system build is normally a period of intense activity, in which a supplier will be involved in life-cycle activities and will need to provide a set of auditable design and development documentation to support the validation program. For this, the entire design and development process should be carried out to written and approved procedures, and all design, development, testing, and verification activities should be documented and approved in order to provide a level of computer system documentation that can be used to support the pharmaceutical manufacturer s life-cycle qualification activities. 

Computer systems validation is an element of the SLC. In addition to the software and hardware testing, other verification activities include code walkthroughs, dynamic analysis, and trace analysis. 

Each phase of the SLC must be controlled to maximize the probability that a finished system meets all quality, regulatory, safety, and specification requirements. If an SLC approach is applied properly, no additional work will be required to validate a system. For each SLC period and event, computer systems validation requires that the development processes are documented work products. As explained in Chapter 2, phase gate verification activities performed during each event may be a perfect place to review and quantify the quality of all products needed to support the next phase. 

Project validation plans should be started during the early stages of a project. Initial project concepts and planning estimates should be elements in the creation of a project validation plans. The initial project verification activities will assess the project team s capability to produce a validated system and provide input for defining the level of testing effort expected. Project verification will identify any critical deviations to the expected project timing and quality levels, as well as other issues affecting the timely approval of the validation report. 

Validation plans and associated schedules are live documents that should be reviewed periodically. Phase gate verification activities, performed during each event, may be a perfect place to review the project plan and schedule. 

All installation qualification activities and resulting data must be verified by a second (independent) person. Evidence of verification activities may be confirmed by signing of the corresponding data collection form verification activities must include the date on which the activity was performed. The reviewer s signature indicates that the test was completed as expected, that the acceptance criteria were met, and that the appropriate documentation/ evidence (if applicable) was collected. 

All computer systems performing regulated operations must be validated. To support computer systems validation, operating systems and system software components are installed according to the manufacturer s instructions. The installation verification includes documentation gathered during the verification activities. 

While it is not essential that the verification check be performed by a supervisor, it is essential that production personnel be absolutely clear regarding FDA s expectations with respect to verification activities. The FDA expects that a verification of calculation and weighing steps be performed concurrently. Additionally, verification does not simply mean initialing the box it requires a review of the work performed for accuracy and completeness. Operators should be made aware of this during GMP training as well as training specific to the batch record. 

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