Computer System Validation

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Companies operating in regulated industries, including the food and beverage and pharmaceutical industries, must comply with numerous regulations. Malisko uses a proven validation process to ensure your company meets Good Automated Manufacturing Practices (GAMP 5) guidelines and follows Title 21 CFR Part 11. Over the past three decades, we’ve helped hundreds of companies achieve regulatory compliance and increase their return on investment.

We perform Computer System Validation (CSV), which confirms that software specifications conform to intended uses and user needs and that the requirements implemented through the software will be consistently met.

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Validation Services for FDA-Regulated Industries

Companies in industries that must comply with FDA regulations for manufacturing must use CSV, which involves complete documentation of the manufacturing automation system. CSV must also address document retention, periodic reviews, technical training, Change Control procedures and standard operating procedures (SOPs).

We provide cost-effective and successful CSV, following GAMP 5 for compliance with Title 21 CFR Part 11. Our testers, writers and subject matter experts all have ample experience with automation systems and can seamlessly merge system documents with validation documents. Our CSV deliverables meet FDA regulatory compliance and pass audits.

We’re experienced in the design, implementation, deployment and validation of electronic records and signatures.

Our validation services for FDA-regulated industries include the following:

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

What You Get From a Fully Tailored Validation Master Plan (VMP)

If your company operates in an FDA-regulated industry, you need CSV. A Validation Master Plan (VMP) from Malisko helps you get there. When you partner with us, we design and implement a system that delivers consistent, efficient production while meeting the FDA’s CSV requirements. We call that a win-win.

When creating a VMP, we outline a master plan that guides our work. The plan documents requirement, design and functional specs; tests plans, institutional and operational protocols; traces matrices and produces summary reports. We also take charge of executing protocols and assist with up-to-date recordkeeping.

We want to deliver a return on investment for you, so we do everything possible to minimize risk and reduce penalties and costs for non-compliance.

While developing your VMP, we provide you with:

Computer System Validation Documentation
Executed Validation Protocols
Electronic Records

Who Needs to Comply With FDA Title 21 CFR Part 11?

FDA-regulated industries need to comply with Title 21 CFR Part 11. Typically, the following types of companies are subject to this rule:

Medical device manufacturers
Biologics developers
Pharmaceutical makers
Biotech companies

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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.

Companies operating in regulated industries, including the food and beverage and pharmaceutical industries, must comply with numerous regulations. Malisko uses a proven validation process to ensure your company meets Good Automated Manufacturing Practices (GAMP 5) guidelines and follows Title 21 CFR Part 11. Over the past three decades, we’ve helped hundreds of companies achieve regulatory compliance and increase their return on investment.

We perform Computer System Validation (CSV), which confirms that software specifications conform to intended uses and user needs and that the requirements implemented through the software will be consistently met.

Validation Services for FDA-Regulated Industries

Companies in industries that must comply with FDA regulations for manufacturing must use CSV, which involves complete documentation of the manufacturing automation system. CSV must also address document retention, periodic reviews, technical training, Change Control procedures and standard operating procedures (SOPs).

We provide cost-effective and successful CSV, following GAMP 5 for compliance with Title 21 CFR Part 11. Our testers, writers and subject matter experts all have ample experience with automation systems and can seamlessly merge system documents with validation documents. Our CSV deliverables meet FDA regulatory compliance and pass audits.

We’re experienced in the design, implementation, deployment and validation of electronic records and signatures.

Our validation services for FDA-regulated industries include the following:

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

What You Get From a Fully Tailored Validation Master Plan (VMP)

If your company operates in an FDA-regulated industry, you need CSV. A Validation Master Plan (VMP) from Malisko helps you get there. When you partner with us, we design and implement a system that delivers consistent, efficient production while meeting the FDA’s CSV requirements. We call that a win-win.

When creating a VMP, we outline a master plan that guides our work. The plan documents requirement, design and functional specs; tests plans, institutional and operational protocols; traces matrices and produces summary reports. We also take charge of executing protocols and assist with up-to-date recordkeeping.

We want to deliver a return on investment for you, so we do everything possible to minimize risk and reduce penalties and costs for non-compliance.

While developing your VMP, we provide you with:

Computer System Validation Documentation
Executed Validation Protocols
Electronic Records

Who Needs to Comply With FDA Title 21 CFR Part 11?

FDA-regulated industries need to comply with Title 21 CFR Part 11. Typically, the following types of companies are subject to this rule:

Medical device manufacturers
Biologics developers
Pharmaceutical makers
Biotech companies

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

by Lauren | September 9, 2020 | Analytics/Reporting, Batch, Case Study, Pharmaceutical, Process Automation, Process Automation Solutions, Reporting, Validation | 0 Comments

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: Optics Healthcare Manufacturer Upgrades Critical Automation in Record Time to Meet Regulatory Compliance

by Lauren | April 29, 2020 | Analytics/Reporting, Case Study, FactoryTalk, HMI, Operations, Pharmaceutical, Physical Network Infrastructure, PLC, Process Automation Solutions, Reporting, System Upgrade, Validation | 0 Comments

Client had systems critical to their manufacturing process that desperately needed replacement.

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

by Lauren | March 4, 2020 | Analytics/Reporting, Case Study, Consumer Packaged Goods, Process Automation Solutions, System Upgrade, Validation | 0 Comments

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

by Lauren | February 20, 2020 | Analytics/Reporting, Case Study, Customer Service, FactoryTalk, HMI, PlantPAx, Process Automation, Reporting, Validation | 0 Comments

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

Reduce Risk and Ensure Compliance With CSV

Malisko offers validation services for the pharmaceutical industry and other FDA-regulated sectors. We’ll maximize your success while minimizing costs and reducing your risk. Contact us today to learn more.

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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. Download our White Paper to learn more.

Corporate Office

500 N Broadway
Suite 1600
St. Louis, MO 63102
314.621.2921

Western Regional Office

4600 S Ulster Street
Suite 1020
Denver, CO 80237

Northern Regional Office

3610 Oakwood Hills Parkway
Suite 2
Eau Claire, WI 54701

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Questions?

info@malisko.com

	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.

	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.

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.

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.

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.

Computer System Validation

Validation Services for FDA-Regulated Industries

What You Get From a Fully Tailored Validation Master Plan (VMP)

Who Needs to Comply With FDA Title 21 CFR Part 11?

Validation Services for FDA-Regulated Industries

What You Get From a Fully Tailored Validation Master Plan (VMP)

Who Needs to Comply With FDA Title 21 CFR Part 11?

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

Case Study: Optics Healthcare Manufacturer Upgrades Critical Automation in Record Time to Meet Regulatory Compliance

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

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

Reduce Risk and Ensure Compliance With CSV

Why Hire a Systems Integrator?

Corporate Office

Western Regional Office

Northern Regional Office

Connect

Questions?

COMPUTER SYSTEM VALIDATION DOCUMENTATION

VALIDATION MASTER PLAN

FUNCTIONAL REQUIREMENTS SPECIFICATION (FRS) DEFINITION

ON-THE-JOB OPERATOR AND ENGINEER TRAINING

DETAILED DESIGN SPECIFICATION

TEST PLAN

TRACEABILITY MATRIX

GENERATE STANDARD OPERATING PROCEDURES (SOPs)

GENERATE INSTALLATION QUALIFICATION PROTOCOLS

GENERATE OPERATIONAL QUALIFICATION PROTOCOLS

EXECUTED VALIDATION PROTOCOLS

PERFORM PROTOCOL EXECUTION

PERFORM VALIDATION SUPPORT

RETROSPECTIVE VALIDATION

21 CFR PART 11 COMPLIANCE AND VALIDATION

GENERATE SUMMARY REPORTS

ELECTRONIC RECORDS

WHAT PART 11 REQUIRES

HOW WE SUCCESSFULLY ENSURE FULL COMPLIANCE

HOW WE MEET SECURITY REQUIREMENTS

HOW WE MEET COMPLIANCE FOR ELECTRONIC RECORDS AND ELECTRONIC SIGNATURES

HOW WE MEET COMPLIANCE FOR STANDARD OPERATING PROCEDURES (SOPs)

HOW WE MEET COMPLIANCE FOR SYSTEM INTEGRITY AND TRACEABILITY

HOW WE MEET VALIDATION & DOCUMENTATION COMPLIANCE

MORE ABOUT OUR COMPLIANCE METHODS