validation activities should begin after design transfer to production specifications, design validation planning can start as soon as user needs and intended uses are specified. Typical validation activities include:

Analysis of relevant scientific literature

• Comparisons to similar devices on the market

• Usability testing (e.g., effectiveness of user interfaces and labeling)

• Simulated use of the device by users

• Clinical trials (e.g., actual use of device per IDE regulations).

When performing design validation, it is important to specify:

• Environment and operating conditions

• Types of users (abilities, skills, and knowledge)

• Type of use (actual or simulated)

• Use of initial production units (or their equivalent).

Validation is a process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in production or testing maintains the desired level of compliance at all stages.

In Pharma Industry it is very important apart from final testing and compliance of product with standard that the process adapted to produce itself must assure that process will consistently produce the expected results

Here the desired results are established in terms of specifications for out come of the process. Qualification of systems and equipment is therefore a part of process of validation.

It is a requirement of food and drug, pharmaceutical regulating agencies like FDA's good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:

Clean Room and HVAC/AHU Validation/Qualification

Compressed Air/Nitrogen Gas Testing or Validation

Pure steam Quality test

Documentation services

Equipment validation

Facilities validation

HVAC system validation

Cleaning validation

Process Validation

Analytical method validation

Computer system validation

Packaging validation

Cold chain validation

Compressed Air Validation

HVAC Validation

Clean Room Validation

Cold chain Validation

PLC Validation

Thermal Validation

Steam Quality Test

Design validation services

Pharma Validation Services

Data-verification validation services

Clean Room AHU Area Validation Services

Calibration validation

Equipment Validation Services

Flow Calibration

IAQ - Indoor Air Quality

Isolator Validation

Biosafety, LAF Validation

The validation scope, boundaries and responsibilities for each process or groups of similar processes or similar equipment's must be documented and approved in a validation plan. These documents, terms and references for the protocol authors are for use in setting the scope of their protocols. It must be based on a Validation Risk Assessment (VRA) to ensure that the scope of validation being authorised is appropriate for the complexity and importance of the equipment or process under validation. Within the references given in the VP the protocol authors must ensure that all aspects of the process or equipment under qualification; that may affect the efficacy, quality and or records of the product are properly qualified. Qualification includes the following steps:

Demonstrates that the proposed design (or the existing design for an off-the-shelf item) will satisfy all the requirements that are defined and detailed in the User Requirements Specification (URS). Satisfactory execution of the DQ is a mandatory requirement before construction (or procurement) of the new design can be authorised.

Demonstrates that the process or equipment meets all specifications, is installed correctly, and all required components and documentation needed for continued operation are installed and in place.

Demonstrates that all facets of the process or equipment are operating correctly.

Demonstrates that the process or equipment performs as intended in a consistent manner over time.

This term refers to the manufacturing of auxiliary components to ensure that they are manufactured to the correct design criteria. This could include packaging components such as folding cartons, shipping cases, labels or even phase change material. All of these components must have some type of random inspection to ensure that the third party manufacturer's process is consistently producing components that are used in the world of GMP at drug or biologic manufacturer.

Clean Room Validation Validation in chennai , HVAC Validation Validation in chennai , AHU Validation Validation in chennai , Qualification Validation in chennai , Mep Validation in chennai , Heating ventilation and air conditioning Validation in chennai , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation in chennai , Validation, Qualification and Calibration , Validation tests for hvac system , Validation Qualification Services , Qualification and Validation in chennai , Compressed Air Validation in chennai , Nitrogen Gas Testing or Validation in chennai , Pure steam Quality test Validation in chennai , Documentation services Validation in chennai , Equipment Validation in chennai , Facilities Validation in chennai , HVAC system Validation in chennai , Cleaning Validation in chennai , process Validation in chennai , Analytical method Validation in chennai , Computer system Validation in chennai , Packaging Validation in chennai , Cold chain Validation in chennai , compressed Air Validation in chennai , HVAC Validation in chennai , Clean Room Validation in chennai , cold chain Validation in chennai , PLC Validation in chennai , Thermal Validation in chennai , Steam Quality Test , Design Validation in chennai , Pharma Validation in chennai , Data verification Validation in chennai , Clean Room AHU Area Validation in chennai , Calibration Validation in chennai , Equipment Validation in chennai , Flow Calibration Validation in chennai , IAQ Indoor Air Quality Validation in chennai , Equipment validation, Facilities Validation in chennai , HVAC system Validation in chennai , Cleaning Validation in chennai , Process Validation in chennai , Analytical method Validation in chennai , Computer system Validation in chennai , Design qualification (DQ) , Component qualification (CQ) , Installation qualification (IQ) , Operational qualification (OQ) , Performance qualification (PQ) , Pharmaceutical Process Validation in chennai , Prospective Validation in chennai , Concurrent Validation in chennai , Retrospective Validation in chennai , Revalidation Periodic and After Change Validation in chennai , Compressed Air Validation in chennai , HVAC Validation in chennai , Clean Room Validation in chennai , PLC Validation in chennai , thermal Validation in chennai , Steam Quality Test , design Validation in chennai , pharmaceutical Validation in chennai , data verification Validation in chennai , Clean Room AHU Area Validation in chennai , Calibration Validation in chennai , Equipment Validation in chennai , IAQ Indoor Air Quality Validation in chennai , IAQ Indoor Air Quality Validation in chennai ... Clean Room validation Services in chennai , HVAC validation Services in chennai , AHU Validation Services in chennai , Qualification validation Services in chennai , Mep validation Services in chennai , Heating ventilation and air conditioning validation Services in chennai , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation Services in chennai , Validation, Qualification and Calibration , Validation tests for hvac system Services in chennai ,, Validation Qualification Services in chennai , Qualification and Validation Services in chennai , Compressed Air Validation Services in chennai , Nitrogen Gas Testing or Validation Services in chennai , Pure steam Quality test Validation Services in chennai , Documentation services Validation Services in chennai , Equipment validation Services in chennai , Facilities validation Services in chennai , HVAC system validation Services in chennai , Cleaning validation Services in chennai , process Validation Services in chennai , Analytical method validation Services in chennai , Computer system validation Services in chennai , Packaging validation Services in chennai , Cold chain validation Services in chennai , compressed Air Validation Services in chennai , HVAC Validation Services in chennai , Clean Room Validation Services in chennai , cold chain Validation Services in chennai , PLC Validation Services in chennai , Thermal Validation Services in chennai , Steam Quality Test Services in chennai , Design validation Services in chennai , Pharma Validation Services in chennai , Data verification validation Services in chennai , Clean Room AHU Area Validation Services in chennai , Calibration validation Services in chennai , Equipment Validation Services in chennai , Flow Calibration Validation Services in chennai , IAQ Indoor Air Quality Validation Services in chennai , Equipment validation Services in chennai , Facilities validation Services in chennai , HVAC system validation Services in chennai , Cleaning validation Services in chennai , Process Validation Services in chennai , Analytical method validation Services in chennai , Computer system validation Services in chennai , Design qualification (DQ) Services in chennai , Component qualification (CQ) Services in chennai , Installation qualification (IQ) Services in chennai , Operational qualification (OQ) Services in chennai , Performance qualification (PQ) Services in chennai , Pharmaceutical Process Validation Services in chennai , Prospective Validation Services in chennai , Concurrent Validation Services in chennai , Retrospective Validation Services in chennai , Revalidation Periodic and After Change validation Services in chennai , Compressed Air Validation Services in chennai , HVAC Validation Services in chennai , Clean Room Validation Services in chennai , PLC Validation Services in chennai , thermal validation Services in chennai , Steam Quality Test Services in chennai, design validation Services in chennai , pharmaceutical validation Services in chennai , data verification validation Services in chennai , Clean Room AHU Area Validation Services in chennai , Calibration validation Services in chennai , Equipment Validation Services in chennai , IAQ Indoor Air Quality Validation Services in chennai , IAQ Indoor Air Quality Validation Services in chennai ...