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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.

 

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.

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

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.

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.

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.

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