Validation

Validation

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If you operate in a regulated industry, such as pharmaceuticals or food and beverage production, we ensure that every aspect of your system is fully compliant with all regulations. We minimize your risk through every stage of our work and use a proven validation process to meet all validation requirements.

Computer System Validation (CSV) is mandatory for industries required to meet FDA regulatory compliance for manufacturing. Comprehensive CSV requires detailed and complete documentation of the manufacturing automation system; from the field devices, networks, controllers, graphic displays through to the data archiving and reporting platforms. Information integrity and security are absolutes in an automation system meeting FDA compliance. Additionally topics such as SOP’s, technical training, periodic reviews, document retention and Change Control procedures must be addressed.

Malisko delivers highly successful and cost effective CSV. We follow GAMP5. Our writers, subject matter experts and testers all have extensive automation system experience. Malisko knows how to seamlessly combine system documents with validation documents so both are complimentary. Malisko can provide comprehensive CSV documentation and execution, or collaborate with a Client’s Compliance Group to provide support as needed. Either way, Malisko’s CSV deliverables meet FDA regulatory compliance and pass audits.

Malisko has experience with designing, implementing, deploying and validating electronic records and signatures – Title 21 CFR Part 11 – for manufacturing automation.

Malisko provides services for both CSV and automation system integration; including and not limited to:

    • Validation Master Plans
    • Test Plans
    • User Requirement Specifications (URS)
    • Functional Requirement Specifications (FRS)
    • Drawing Data Sheet (DDS)
    • Comprehensive Design Specification (DS)
    • Descriptions of Operation including Normal, Challenge, Recovery, and Alarm Operations
    • Standard Operating Procedures (SOPs)
    • Traceability Matrix
    • Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
    • Deviation Reports during Qualification Execution
    • Test Reports
    • Validation Summary Reports

Malisko Engineering helps Clients in the FDA regulated industries with CSV that is complete, detailed and meets the stringent demand of auditors.

Computer System Validation (CSV) is a must in FDA regulated industries. We design and implement your system to deliver consistent, efficient production that also meets CSV for FDA. And we prove it too. If you operate in a regulated industry, we take care of the paperwork related to CSV and reduce your Regulatory risk. We can provide a Validation Master Plan (VMP) and use it to guide our work. We document requirement specs, design specs, functional specs, test plans, installation and operational protocols, trace matrices, and summary reports. We execute the protocols as well. We assist with keeping your records up-to-date via change control and help keep your system in compliance. Minimizing risk is ingrained in our company because we are committed to delivering you ROI.

During this phase we can provide you with:

Click the links above to learn more about each one.

If you operate in a regulated industry, such as pharmaceuticals or food and beverage production, we ensure that every aspect of your system is fully compliant with all regulations. We minimize your risk through every stage of our work and use a proven validation process to meet all validation requirements.

Computer System Validation (CSV) is mandatory for industries required to meet FDA regulatory compliance for manufacturing. Comprehensive CSV requires detailed and complete documentation of the manufacturing automation system; from the field devices, networks, controllers, graphic displays through to the data archiving and reporting platforms. Information integrity and security are absolutes in an automation system meeting FDA compliance. Additionally topics such as SOP’s, technical training, periodic reviews, document retention and Change Control procedures must be addressed.

Malisko delivers highly successful and cost effective CSV. We follow GAMP5. Our writers, subject matter experts and testers all have extensive automation system experience. Malisko knows how to seamlessly combine system documents with validation documents so both are complimentary. Malisko can provide comprehensive CSV documentation and execution, or collaborate with a Client’s Compliance Group to provide support as needed. Either way, Malisko’s CSV deliverables meet FDA regulatory compliance and pass audits.

Malisko has experience with designing, implementing, deploying and validating electronic records and signatures – Title 21 CFR Part 11 – for manufacturing automation.

Malisko provides services for both CSV and automation system integration; including and not limited to:

    • Validation Master Plans
    • Test Plans
    • User Requirement Specifications (URS)
    • Functional Requirement Specifications (FRS)
    • Drawing Data Sheet (DDS)
    • Comprehensive Design Specification (DS)
    • Descriptions of Operation including Normal, Challenge, Recovery, and Alarm Operations
    • Standard Operating Procedures (SOPs)
    • Traceability Matrix
    • Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
    • Deviation Reports during Qualification Execution
    • Test Reports
    • Validation Summary Reports

Malisko Engineering helps Clients in the FDA regulated industries with CSV that is complete, detailed and meets the stringent demand of auditors.

Computer System Validation (CSV) is a must in FDA regulated industries. We design and implement your system to deliver consistent, efficient production that also meets CSV for FDA. And we prove it too. If you operate in a regulated industry, we take care of the paperwork related to CSV and reduce your Regulatory risk. We can provide a Validation Master Plan (VMP) and use it to guide our work. We document requirement specs, design specs, functional specs, test plans, installation and operational protocols, trace matrices, and summary reports. We execute the protocols as well. We assist with keeping your records up-to-date via change control and help keep your system in compliance. Minimizing risk is ingrained in our company because we are committed to delivering you ROI.

During this phase we can provide you with:

Click the links above to learn more about each one.

Case Study: Pharmaceutical Company Begins Manufacturing New Generic Therapeutic Drug with The Help Of Advanced Process Automation System

A pharmaceutical manufacturer needed to finalize production of a new generic therapeutic drug. As part of their initiative, they wanted to include a state-of-the-art, robust, expandable, and supportable automation system to control, data archive and report on their world-class process.

Case Study: Infant Formula Manufacturer Enhances Its Ability to Capture and Retain Secure Historical Data

A historian collecting manufacturing data on highly critical infant formula is extremely vital for the safe and healthy future of our most prized possessions: babies.

Case Study: Emergency Callout Service (ECS) at Christmas Time Quickly Resolves Problems in Plant’s Critical Operations

A client contacted Malisko to assist with getting a critical system back up and running; a system that Malisko had nothing to do with.

Why Hire a Systems Integrator?

Can’t decide between a systems integrator and a general contractor for plant automation? Learn how systems integrators save you money, add value and ensure quality. Simply provide your information below to download our White Paper.

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COMPUTER SYSTEM VALIDATION DOCUMENTATION

Our documentation services are a crucial step in validating your manufacturing automation systems and reducing those risks. Through validation documentation, we meticulously document how your system works under normal, upset and recovery conditions, list functional requirements, provide detailed design documentation, help you generate relevant standard operating procedures and create execution protocols. This highly detailed process mitigates risks and greatly enhances your compliance with regulatory requirements.

VALIDATION MASTER PLAN

We start our documentation process by creating a Validation Master Plan (VMP) that guides every aspect of the validation process. The VMP defines your facility’s areas and systems that will be validated and provides a written roadmap for your facility to achieve and maintain validation. The VMP will include computer system validation, facility and utility qualification and validation, stakeholders and participants, equipment identification and summary of documents. This document shows auditors and inspectors a well-planned validation strategy with logical reasoning based on a risk assessment.


FUNCTIONAL REQUIREMENTS SPECIFICATION (FRS) DEFINITION

When you work with us at Malisko Engineering, you don’t just get an automation system. You get a team of committed experts who become an extension of your team. After system commissioning, we can provide 24/7, on-site support for your system. We work side-by-side with your operators, and technical support team to ensure the system does what we said it would do. We also understand how important it is to get your manufacturing line producing as quickly as possible. That’s why we finish the jobs on time.


ON-THE-JOB OPERATOR AND ENGINEER TRAINING

When we define the functional requirements of your system, we document what your process control system should do and specify its required behavior. We provide you, your team and auditors with a comprehensive written description of your system’s operation and planned performance. The FRS becomes one of the foundational pieces we use to create an operational protocol necessary to validate your process operation.

Detailed Design Specification The Detailed Design Specification (DDS) describes the hardware and software platforms of your automation system to be validated. The DDS also quantifies the how each system component is to be configured as well as how each component factors into making a completed automation system.


DETAILED DESIGN SPECIFICATION

The Detailed Design Specification (DDS) describes the hardware and software platforms of your automation system to be validated. The DDS also quantifies how each system component is to be configured as well as how each component factors into making a completed automation system.


TEST PLAN

The Test Plan specifies precisely how we perform off-site system integration testing and on-site validation testing on your hardware, software and networking components after completing code development and then after completing on-site process commissioning and system installation. Before your system handles any live runs, we test it in both a simulated environment and on-site at your facility. Through rigorous testing, we reduce your operational risks, and make validation protocol execution much smoother and more efficient.


TRACEABILITY MATRIX

In the Traceability Matrix, we define the relationship between the Requirements Specification Documents, Design and Functional Documents, and Validation Protocol Test Scripts. We use the Traceability Matrix to ensure that system validation addresses all requirements, specifications, and functions that were noted in the system specifications. The Traceability Matrix provides you evidence and a documented cross-reference to show that your automation system meets the stated requirements and specifications.


GENERATE STANDARD OPERATING PROCEDURES (SOPs)

SOPs relating to a validated manufacturing automation system are essential for the proper sustainability of the system throughout its life cycle. Topics covered by SOPs include document storage, change control, disaster recovery, training, audit trail, system updates, periodic reviews and system retirement.

With proper SOPs, you have repeatable, unchanged processes, procedures, and documentation that allow you to identify the causes and effects of any system issues through ongoing system performance tracking. We don’t just meet regulations. We help you use SOPs to stay compliant with regulatory regulations while keeping your production at maximum efficiency and achieve uniformity throughout your production process.


GENERATE INSTALLATION QUALIFICATION PROTOCOLS

The Installation Qualification (IQ) verifies the proper installation and configuration of your system. Your IQ ensures that necessary software modules have been loaded, equipment has been installed, configured and calibrated, the necessary procedures have been approved, and the appropriate personnel have received the appropriate training. The IQ follows the installation requirements that we define in the Detail Design Specification. IQ must be performed before completing the Operational Qualification or Performance Qualification. Through the IQ, we validate the installation and configuration of your system and keep you in compliance.


GENERATE OPERATIONAL QUALIFICATION PROTOCOLS

The Operational Qualification (OQ) is a collection of test scripts we use to verify that your system functions properly under normal, stress, upset, recovery and abort conditions. Through the OQ, we validate that your system will work and make it straightforward for auditors and inspectors to verify your system’s repeatable operation as designed through documented evidence. We perform the OQ before the system is released for production use.

EXECUTED VALIDATION PROTOCOLS

Through CSV documentation, we set you on the right course to ensure your system complies with FDA regulations. When we integrate your system, we also document every step of our work consistent with CSV. If you prefer to have your in-house team document and execute validation protocols, we can be right there with you, supporting your team to ensure a thorough and accurate validation. When your system is in place, we can help you place your automation system in full compliance with FDA regulations.

PERFORM PROTOCOL EXECUTION

To validate your automation system, you are required to execute protocols for Installation Qualification (IQ), Operational Qualification (OQ) and, potentially, Performance Qualification (PQ). When we execute the IQ, OQ, and PQ, we go through every document and execute the test scripts while following the test plan to validate every portion of your automation system. We ensure that your system is completely tested, that you have documented evidence of the tests and that the CSV meets regulatory standards.


PERFORM VALIDATION SUPPORT

In some instances, we find that our customers employ a validation staff who are responsible for CSV within their facilities. We know how to support that sta. If your compliance team creates and executes the validation documents, we’re there to help assist them in any manner they need. Whether it’s our team or your team executing the protocols, we assist to assure that your system is thoroughly and accurately validated.


RETROSPECTIVE VALIDATION

We can perform a gap analysis followed by a retrospective validation for existing manufacturing automation systems that are already in operation but might not meet current FDA regulations for CSV. We might be able to use existing system documentation as a starting point for creating the other needed CSV documents. When we perform a retrospective validation we are very conscience of being fiscally responsible while helping you bring your automation system up to current regulatory compliance.


21 CFR PART 11 COMPLIANCE AND VALIDATION

Manufacturing automation systems that store data used to assess product quality and/or product integrity decisions within a facility under FDA compliance must meet Title 21 CFR Part 11 requirements for Electronic Records and Electronic Signatures. To comply with CFR Part 11, you need CSV documentation that clearly defines system operations and maintenance for unadulterated data integrity, data access and storage, physical and system security as well as audit trails and traceability.

At Malisko Engineering, we have the experience to help you create and execute a CSV plan that produces a comprehensive set of documented evidence demonstrating that your system meets 21 CFR Part 11.


GENERATE SUMMARY REPORTS

Validation Summary Reports provide an overview of your entire validation process. These reports include a description of your validation approach, a test definition, a record of tests, test results, test deviations and resolutions of those deviations, and a summary statement declaring that your system meets the defined requirements.

Once the system owner and other stakeholders identified in the Validation Master Plan review and sign the summary report, your validation project is complete. The finished package of validation documents is a CSV portfolio where we align every document to fit together so that the methods, details, execution steps and results flow in a logical fashion. Once our validation project is complete, you’ll have all validation packages stored according to your site document control procedures.

ELECTRONIC RECORDS

For manufacturers operating in FDA-regulated industries, such as life sciences and pharmaceutical, Title 21 CFR Part 11 mandates the requirements of automation systems for electronic records and electronic signatures. We have implemented numerous automated production systems over the years meeting Part 11 and can help you with completing your journey to Part 11 compliance of your manufacturing automation systems.

WHAT PART 11 REQUIRES

Title 21 CFR Part 11 places data integrity, security and audit trail requirements on open and closed systems. A closed system is an environment where system access is controlled by the persons responsible for the content of electronic records on the system. An open system is an environment where it’s not. Most computer-based Control, Data Acquisition and Reporting Systems used in manufacturing are closed systems.

Unsure about CFR Part 11 Requirements and Guidance? Download them now.

HOW WE SUCCESSFULLY ENSURE FULL COMPLIANCE

We leverage our extensive experience and automation expertise to ensure that your system meets Part 11 requirements for:

 
We provide related SCV documentation. When we complete our work, you have a system that complies with.

HOW WE MEET SECURITY REQUIREMENTS

REQUIREMENT: Employ procedures and controls designed to ensure the authenticity, integrity, and confidentiality of electronic records.
   
SOLUTION: We develop Standard Operating Procedures (SOPs) to support the use of electronic records in the regulated environment. We validate the procedures and system. The validation follows an established System Life Cycle (SLC) methodology; such as GAMP V (ISPE).

REQUIREMENT: Limit system access to authorized individuals only.
   
SOLUTION: We specify limited physical access to the servers and data storage devices. We also specify robust Windows Security. We ensure user account policies implement password aging, minimum password length, password uniqueness, and account lockout after a reasonable number (typically 5) of unsuccessful login attempts. And we configure each Operator Node to use ‘User Login’ Timeout.

HOW WE MEET COMPLIANCE FOR ELECTRONIC RECORDS AND ELECTRONIC SIGNATURES

REQUIREMENT: Generate accurate and complete copies of records in both human-readable and electronic format. Protect records to enable their accurate and are ready-retrieval throughout the records retention period.
   
SOLUTION: We help develop SOPs to ensure that records are securely retained for an appropriate duration of time.

REQUIREMENT: Implement secure, computer-generated, time-stamped audit trails.
   
SOLUTION: We specify Microsoft Windows Clock Synchronization among all computers and servers in the application.

REQUIREMENT: Ensure that signed Electronic Records (ER) contain the following:

  • Printed name of the signer
  • Date and time when the signature was executed
  • Meaning of signature – i.e. review, approval, responsibility, authorship. Ensure these requirements also apply to ANY human-readable form of the ER – both the hard-copy printout and electronic display.
   
SOLUTION: We make sure the audit trails includes:

  • Date and time stamp
  • Node of origination
  • Operator's User Name
  • Action Taken
  • What Parameter (Tag Name) Acted Upon
  • Message Type

REQUIREMENT: Ensure Electronic Signatures (ES) and Hand-Written Signatures executed to ERs are linked to their respective ERs in such a way as to ensure that signatures cannot be excised, copied, or otherwise transferred to falsify an ER by ordinary means
   
SOLUTION: We help develop SOPs to prevent unauthorized access to the Relational Database containing the Audit Trail File. We also validate the procedures and system.

HOW WE MEET COMPLIANCE FOR STANDARD OPERATING PROCEDURES (SOPs)

REQUIREMENT: Establish and adhere to written policies that hold individuals accountable and responsible for actions initiated under their ESs to deter record and signature falsification.
   
SOLUTION: We help develop SOPs to support the use of ERs and ESs in your Regulated Environment. And we validate the policies and system.

REQUIREMENT: Establish and adhere to written policies that:

  • Maintain the uniqueness of each combined identification code and password
  • Periodically check, recall, or revise ID code and password issuances
  • Follow loss management procedures to electronically deauthorize stolen, missing, or compromised tokens, cards, or other devices
  • Use transaction safeguards to prevent unauthorized use of IDs and PWs Conduct initial and periodic device testing
   
SOLUTION: We employ one of two possible scenarios. Use current, robust SOPs already in place via our clients’ IT/IM departments; or develop new SOPs to control and properly maintain the identification names and passwords of individuals. And we validate the policies and systems with Qualification protocols.

HOW WE MEET COMPLIANCE FOR SYSTEM INTEGRITY AND TRACEABILITY

REQUIREMENT: Use operational system checks to enforce permitted sequencing of steps and events.
   
SOLUTION: We typically recommend logging all Parameter (Recipe) downloads, sequence events, and operator actions in a secure SQL database.

REQUIREMENT: Use device checks to determine the validity and integrity of the source of data input or operation instructions.
   
SOLUTION: We verify sources of data input, such as operator stations (thin clients) as part of the validation process, restrict access to program code only by authorized technical support personnel, and deploy recipe/formula/operational procedures to a secure server computer environment.

REQUIREMENT: Ensure revision and change control procedures to maintain an audit trail that documents time-sequenced developments and modifications of system documentation.
   
SOLUTION: We typically cover this requirement with the IQ and OQ Validation Protocols, Change Control procedures and existing IT/IM and Compliance SOPs.

HOW WE MEET VALIDATION & DOCUMENTATION COMPLIANCE

REQUIREMENT: Validate the system to ensure the accuracy, reliability, and consistency of intended performance while providing the ability to discern invalid or altered records.
   
SOLUTION: We develop and execute IQ and OQ Validation Protocols creating documented evidence of compliance with Title 21 CFR Part 11.

REQUIREMENT: Ensure adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.
   
SOLUTION: We help align SOPs to cover this requirement.

MORE ABOUT OUR COMPLIANCE METHODS

Our Validation efforts help ensure you establish and adhere to qualification criteria for persons who develop, maintain or use the ER/ES system and ensure teams have education, training, and experience to perform their assigned tasks.

We help ensure that your closed computer systems have a collection of technological and procedural controls to protect data within your system. We help make sure that safeguards are in place so your electronic records are authentic, incorruptible, and confidential.

We provide accurate record generation so that records entered into the system are completely retrievable without unexpected alteration or unrecorded changes. We test this during validation by verifying that records entered into your system are accurately displayed and accurately exported from your system with no adulteration.

And we provide the related validation documentation that you need as evidence that your manufacturing automation system meets Part 11 compliance.

COMPUTER SYSTEM VALIDATION DOCUMENTATION

Our documentation services are a crucial step in validating your manufacturing automation systems and reducing those risks. Through validation documentation, we meticulously document how your system works under normal, upset and recovery conditions, list functional requirements, provide detailed design documentation, help you generate relevant standard operating procedures and create execution protocols. This highly detailed process mitigates risks and greatly enhances your compliance with regulatory requirements.

VALIDATION MASTER PLAN

We start our documentation process by creating a Validation Master Plan (VMP) that guides every aspect of the validation process. The VMP defines your facility’s areas and systems that will be validated and provides a written roadmap for your facility to achieve and maintain validation. The VMP will include computer system validation, facility and utility qualification and validation, stakeholders and participants, equipment identification and summary of documents. This document shows auditors and inspectors a well-planned validation strategy with logical reasoning based on a risk assessment.


FUNCTIONAL REQUIREMENTS SPECIFICATION (FRS) DEFINITION

When you work with us at Malisko Engineering, you don’t just get an automation system. You get a team of committed experts who become an extension of your team. After system commissioning, we can provide 24/7, on-site support for your system. We work side-by-side with your operators, and technical support team to ensure the system does what we said it would do. We also understand how important it is to get your manufacturing line producing as quickly as possible. That’s why we finish the jobs on time.


ON-THE-JOB OPERATOR AND ENGINEER TRAINING

When we define the functional requirements of your system, we document what your process control system should do and specify its required behavior. We provide you, your team and auditors with a comprehensive written description of your system’s operation and planned performance. The FRS becomes one of the foundational pieces we use to create an operational protocol necessary to validate your process operation.

Detailed Design Specification The Detailed Design Specification (DDS) describes the hardware and software platforms of your automation system to be validated. The DDS also quantifies the how each system component is to be configured as well as how each component factors into making a completed automation system.


DETAILED DESIGN SPECIFICATION

The Detailed Design Specification (DDS) describes the hardware and software platforms of your automation system to be validated. The DDS also quantifies how each system component is to be configured as well as how each component factors into making a completed automation system.


TEST PLAN

The Test Plan specifies precisely how we perform off-site system integration testing and on-site validation testing on your hardware, software and networking components after completing code development and then after completing on-site process commissioning and system installation. Before your system handles any live runs, we test it in both a simulated environment and on-site at your facility. Through rigorous testing, we reduce your operational risks, and make validation protocol execution much smoother and more efficient.


TRACEABILITY MATRIX

In the Traceability Matrix, we define the relationship between the Requirements Specification Documents, Design and Functional Documents, and Validation Protocol Test Scripts. We use the Traceability Matrix to ensure that system validation addresses all requirements, specifications, and functions that were noted in the system specifications. The Traceability Matrix provides you evidence and a documented cross-reference to show that your automation system meets the stated requirements and specifications.


GENERATE STANDARD OPERATING PROCEDURES (SOPs)

SOPs relating to a validated manufacturing automation system are essential for the proper sustainability of the system throughout its life cycle. Topics covered by SOPs include document storage, change control, disaster recovery, training, audit trail, system updates, periodic reviews and system retirement.

With proper SOPs, you have repeatable, unchanged processes, procedures, and documentation that allow you to identify the causes and effects of any system issues through ongoing system performance tracking. We don’t just meet regulations. We help you use SOPs to stay compliant with regulatory regulations while keeping your production at maximum efficiency and achieve uniformity throughout your production process.


GENERATE INSTALLATION QUALIFICATION PROTOCOLS

The Installation Qualification (IQ) verifies the proper installation and configuration of your system. Your IQ ensures that necessary software modules have been loaded, equipment has been installed, configured and calibrated, the necessary procedures have been approved, and the appropriate personnel have received the appropriate training. The IQ follows the installation requirements that we define in the Detail Design Specification. IQ must be performed before completing the Operational Qualification or Performance Qualification. Through the IQ, we validate the installation and configuration of your system and keep you in compliance.


GENERATE OPERATIONAL QUALIFICATION PROTOCOLS

The Operational Qualification (OQ) is a collection of test scripts we use to verify that your system functions properly under normal, stress, upset, recovery and abort conditions. Through the OQ, we validate that your system will work and make it straightforward for auditors and inspectors to verify your system’s repeatable operation as designed through documented evidence. We perform the OQ before the system is released for production use.

EXECUTED VALIDATION PROTOCOLS

Through CSV documentation, we set you on the right course to ensure your system complies with FDA regulations. When we integrate your system, we also document every step of our work consistent with CSV. If you prefer to have your in-house team document and execute validation protocols, we can be right there with you, supporting your team to ensure a thorough and accurate validation. When your system is in place, we can help you place your automation system in full compliance with FDA regulations.

PERFORM PROTOCOL EXECUTION

To validate your automation system, you are required to execute protocols for Installation Qualification (IQ), Operational Qualification (OQ) and, potentially, Performance Qualification (PQ). When we execute the IQ, OQ, and PQ, we go through every document and execute the test scripts while following the test plan to validate every portion of your automation system. We ensure that your system is completely tested, that you have documented evidence of the tests and that the CSV meets regulatory standards.


PERFORM VALIDATION SUPPORT

In some instances, we find that our customers employ a validation staff who are responsible for CSV within their facilities. We know how to support that sta. If your compliance team creates and executes the validation documents, we’re there to help assist them in any manner they need. Whether it’s our team or your team executing the protocols, we assist to assure that your system is thoroughly and accurately validated.


RETROSPECTIVE VALIDATION

We can perform a gap analysis followed by a retrospective validation for existing manufacturing automation systems that are already in operation but might not meet current FDA regulations for CSV. We might be able to use existing system documentation as a starting point for creating the other needed CSV documents. When we perform a retrospective validation we are very conscience of being fiscally responsible while helping you bring your automation system up to current regulatory compliance.


21 CFR PART 11 COMPLIANCE AND VALIDATION

Manufacturing automation systems that store data used to assess product quality and/or product integrity decisions within a facility under FDA compliance must meet Title 21 CFR Part 11 requirements for Electronic Records and Electronic Signatures. To comply with CFR Part 11, you need CSV documentation that clearly defines system operations and maintenance for unadulterated data integrity, data access and storage, physical and system security as well as audit trails and traceability.

At Malisko Engineering, we have the experience to help you create and execute a CSV plan that produces a comprehensive set of documented evidence demonstrating that your system meets 21 CFR Part 11.


GENERATE SUMMARY REPORTS

Validation Summary Reports provide an overview of your entire validation process. These reports include a description of your validation approach, a test definition, a record of tests, test results, test deviations and resolutions of those deviations, and a summary statement declaring that your system meets the defined requirements.

Once the system owner and other stakeholders identified in the Validation Master Plan review and sign the summary report, your validation project is complete. The finished package of validation documents is a CSV portfolio where we align every document to fit together so that the methods, details, execution steps and results flow in a logical fashion. Once our validation project is complete, you’ll have all validation packages stored according to your site document control procedures.

ELECTRONIC RECORDS

For manufacturers operating in FDA-regulated industries, such as life sciences and pharmaceutical, Title 21 CFR Part 11 mandates the requirements of automation systems for electronic records and electronic signatures. We have implemented numerous automated production systems over the years meeting Part 11 and can help you with completing your journey to Part 11 compliance of your manufacturing automation systems.

WHAT PART 11 REQUIRES

Title 21 CFR Part 11 places data integrity, security and audit trail requirements on open and closed systems. A closed system is an environment where system access is controlled by the persons responsible for the content of electronic records on the system. An open system is an environment where it’s not. Most computer-based Control, Data Acquisition and Reporting Systems used in manufacturing are closed systems.

Unsure about CFR Part 11 Requirements and Guidance? Download them now.

HOW WE SUCCESSFULLY ENSURE FULL COMPLIANCE

We leverage our extensive experience and automation expertise to ensure that your system meets Part 11 requirements for:

 
We provide related SCV documentation. When we complete our work, you have a system that complies with.

HOW WE MEET SECURITY REQUIREMENTS

REQUIREMENT: Employ procedures and controls designed to ensure the authenticity, integrity, and confidentiality of electronic records.
   
SOLUTION: We develop Standard Operating Procedures (SOPs) to support the use of electronic records in the regulated environment. We validate the procedures and system. The validation follows an established System Life Cycle (SLC) methodology; such as GAMP V (ISPE).

REQUIREMENT: Limit system access to authorized individuals only.
   
SOLUTION: We specify limited physical access to the servers and data storage devices. We also specify robust Windows Security. We ensure user account policies implement password aging, minimum password length, password uniqueness, and account lockout after a reasonable number (typically 5) of unsuccessful login attempts. And we configure each Operator Node to use ‘User Login’ Timeout.

HOW WE MEET COMPLIANCE FOR ELECTRONIC RECORDS AND ELECTRONIC SIGNATURES

REQUIREMENT: Generate accurate and complete copies of records in both human-readable and electronic format. Protect records to enable their accurate and are ready-retrieval throughout the records retention period.
   
SOLUTION: We help develop SOPs to ensure that records are securely retained for an appropriate duration of time.

REQUIREMENT: Implement secure, computer-generated, time-stamped audit trails.
   
SOLUTION: We specify Microsoft Windows Clock Synchronization among all computers and servers in the application.

REQUIREMENT: Ensure that signed Electronic Records (ER) contain the following:

  • Printed name of the signer
  • Date and time when the signature was executed
  • Meaning of signature – i.e. review, approval, responsibility, authorship. Ensure these requirements also apply to ANY human-readable form of the ER – both the hard-copy printout and electronic display.
   
SOLUTION: We make sure the audit trails includes:

  • Date and time stamp
  • Node of origination
  • Operator's User Name
  • Action Taken
  • What Parameter (Tag Name) Acted Upon
  • Message Type

REQUIREMENT: Ensure Electronic Signatures (ES) and Hand-Written Signatures executed to ERs are linked to their respective ERs in such a way as to ensure that signatures cannot be excised, copied, or otherwise transferred to falsify an ER by ordinary means
   
SOLUTION: We help develop SOPs to prevent unauthorized access to the Relational Database containing the Audit Trail File. We also validate the procedures and system.

HOW WE MEET COMPLIANCE FOR STANDARD OPERATING PROCEDURES (SOPs)

REQUIREMENT: Establish and adhere to written policies that hold individuals accountable and responsible for actions initiated under their ESs to deter record and signature falsification.
   
SOLUTION: We help develop SOPs to support the use of ERs and ESs in your Regulated Environment. And we validate the policies and system.

REQUIREMENT: Establish and adhere to written policies that:

  • Maintain the uniqueness of each combined identification code and password
  • Periodically check, recall, or revise ID code and password issuances
  • Follow loss management procedures to electronically deauthorize stolen, missing, or compromised tokens, cards, or other devices
  • Use transaction safeguards to prevent unauthorized use of IDs and PWs Conduct initial and periodic device testing
   
SOLUTION: We employ one of two possible scenarios. Use current, robust SOPs already in place via our clients’ IT/IM departments; or develop new SOPs to control and properly maintain the identification names and passwords of individuals. And we validate the policies and systems with Qualification protocols.

HOW WE MEET COMPLIANCE FOR SYSTEM INTEGRITY AND TRACEABILITY

REQUIREMENT: Use operational system checks to enforce permitted sequencing of steps and events.
   
SOLUTION: We typically recommend logging all Parameter (Recipe) downloads, sequence events, and operator actions in a secure SQL database.

REQUIREMENT: Use device checks to determine the validity and integrity of the source of data input or operation instructions.
   
SOLUTION: We verify sources of data input, such as operator stations (thin clients) as part of the validation process, restrict access to program code only by authorized technical support personnel, and deploy recipe/formula/operational procedures to a secure server computer environment.

REQUIREMENT: Ensure revision and change control procedures to maintain an audit trail that documents time-sequenced developments and modifications of system documentation.
   
SOLUTION: We typically cover this requirement with the IQ and OQ Validation Protocols, Change Control procedures and existing IT/IM and Compliance SOPs.

HOW WE MEET VALIDATION & DOCUMENTATION COMPLIANCE

REQUIREMENT: Validate the system to ensure the accuracy, reliability, and consistency of intended performance while providing the ability to discern invalid or altered records.
   
SOLUTION: We develop and execute IQ and OQ Validation Protocols creating documented evidence of compliance with Title 21 CFR Part 11.

REQUIREMENT: Ensure adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance.
   
SOLUTION: We help align SOPs to cover this requirement.

MORE ABOUT OUR COMPLIANCE METHODS

Our Validation efforts help ensure you establish and adhere to qualification criteria for persons who develop, maintain or use the ER/ES system and ensure teams have education, training, and experience to perform their assigned tasks.

We help ensure that your closed computer systems have a collection of technological and procedural controls to protect data within your system. We help make sure that safeguards are in place so your electronic records are authentic, incorruptible, and confidential.

We provide accurate record generation so that records entered into the system are completely retrievable without unexpected alteration or unrecorded changes. We test this during validation by verifying that records entered into your system are accurately displayed and accurately exported from your system with no adulteration.

And we provide the related validation documentation that you need as evidence that your manufacturing automation system meets Part 11 compliance.