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PLC VALIDATION
 
 
 
PLC Based Computerized System And Validation Procedure
 
  • PLC is a computer that can develop programs that are equivalent to relay circuits which control processes. PLC consists of the common part that is fully in accordance with the integrated regulations, and parts that are individually different depending on each manufacturer. Each part is an independent computer called a unit, and each of the parts is interactively connected with other units or networks. The common part is written in the programming language
  • * Identify which computerised systems are subject to validation.
  • * Provide brief descriptions of the validation strategies for different categories of computerised systems as well as other validation activities.
  • * Outline protocols and related test procedures for all validation activities including computer systems.
  • * Define reporting requirements to document validation exercises and related results.
  • * Identify key personnel and their responsibilities as part of the Validation Program.
  •  
    PLC Validation Tests and Interpretations.
     
  • 1) Dynamic Testing.
  • 2) Static Analysis.
  • 3) Abstract Interpretation Verification.
  • 4) Revalidation Scheduled.
  • 5) Revalidation on Relocation.
  • 6) Revalidation Justification.
  • 7) Procurement and PLC Validation.
  •  
    What is validation?
     
  • 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:
  •  
    Validation Services
     
  • 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 Process:
     
  • 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:
  •  
    Design qualification (DQ)
     
  • 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.
  •  
    Installation qualification (IQ)
     
  • 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.
  •  
    Operational qualification (OQ)
     
  • Demonstrates that all facets of the process or equipment are operating correctly.
  •  
    Performance qualification (PQ)
     
  • Demonstrates that the process or equipment performs as intended in a consistent manner over time.
  •  
    Component qualification (CQ)
     
  • 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.
  •  
    Validation List
     
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    Validation Services List
     
    Clean Room validation Services in bilaspur , HVAC validation Services in bilaspur , AHU Validation Services in bilaspur , Qualification validation Services in bilaspur , Mep validation Services in bilaspur , Heating ventilation and air conditioning validation Services in bilaspur , Validation and qualification of HVAC system , Heating, ventilation and air conditioning Validation Services in bilaspur , Validation, Qualification and Calibration , Validation tests for hvac system Services in bilaspur ,, Validation Qualification Services in bilaspur , Qualification and Validation Services in bilaspur , Compressed Air Validation Services in bilaspur , Nitrogen Gas Testing or Validation Services in bilaspur , Pure steam Quality test Validation Services in bilaspur , Documentation services Validation Services in bilaspur , Equipment validation Services in bilaspur , Facilities validation Services in bilaspur , HVAC system validation Services in bilaspur , Cleaning validation Services in bilaspur , process Validation Services in bilaspur , Analytical method validation Services in bilaspur , Computer system validation Services in bilaspur , Packaging validation Services in bilaspur , Cold chain validation Services in bilaspur , compressed Air Validation Services in bilaspur , HVAC Validation Services in bilaspur , Clean Room Validation Services in bilaspur , cold chain Validation Services in bilaspur , PLC Validation Services in bilaspur , Thermal Validation Services in bilaspur , Steam Quality Test Services in bilaspur , Design validation Services in bilaspur , Pharma Validation Services in bilaspur , Data verification validation Services in bilaspur , Clean Room AHU Area Validation Services in bilaspur , Calibration validation Services in bilaspur , Equipment Validation Services in bilaspur , Flow Calibration Validation Services in bilaspur , IAQ Indoor Air Quality Validation Services in bilaspur , Equipment validation Services in bilaspur , Facilities validation Services in bilaspur , HVAC system validation Services in bilaspur , Cleaning validation Services in bilaspur , Process Validation Services in bilaspur , Analytical method validation Services in bilaspur , Computer system validation Services in bilaspur , Design qualification (DQ) Services in bilaspur , Component qualification (CQ) Services in bilaspur , Installation qualification (IQ) Services in bilaspur , Operational qualification (OQ) Services in bilaspur , Performance qualification (PQ) Services in bilaspur , Pharmaceutical Process Validation Services in bilaspur , Prospective Validation Services in bilaspur , Concurrent Validation Services in bilaspur , Retrospective Validation Services in bilaspur , Revalidation Periodic and After Change validation Services in bilaspur , Compressed Air Validation Services in bilaspur , HVAC Validation Services in bilaspur , Clean Room Validation Services in bilaspur , PLC Validation Services in bilaspur , thermal validation Services in bilaspur , Steam Quality Test Services in bilaspur, design validation Services in bilaspur , pharmaceutical validation Services in bilaspur , data verification validation Services in bilaspur , Clean Room AHU Area Validation Services in bilaspur , Calibration validation Services in bilaspur , Equipment Validation Services in bilaspur , IAQ Indoor Air Quality Validation Services in bilaspur , IAQ Indoor Air Quality Validation Services in bilaspur ...
     
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    list of our services following states
     
    andaman and nicobar islands | andhra pradesh | arunachal pradesh | assam | bihar | chandigarh | chhattisgarh | delhi | goa | gujarat | haryana | himachal pradesh | jbilaspur and kashmir | jharkhand | karnataka | kerala | ladakh | lakshadweep | madhya pradesh | maharashtra | manipur | meghalaya | mizoram | nagaland | odisha | puducherry | punjab | rajasthan | sikkim | tamil nadu | telangana | the dadra and nagar haveli and daman and diu | tripura | uttarakhand | uttar pradesh | west bengal ...
     
    list of our services following districts
     
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    list of our services following districts
     
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