CQV for Pharma, Biotech, Healthcare, and Life Science Industries

cGMP Validation Services

Validation is a systematic process of data collection and documentation to demonstrate that your business processes consistently work as intended and produce high-quality results. From process ideation to commercial production, validation is a necessary step at every stage of the product life cycle.

VaLogic specializes in validation services that adhere to current Good Manufacturing Practices (cGMP) for pharmaceuticals, biotechnology, and other life science disciplines. Our expert-led validation processes mitigate risks, certify compliance, and boost operational reliability to ensure your products meet the highest quality standards.

The Benefits of Validation Services

  • Ensure Compliance: Stay up-to-date with current regulatory standards, including FDA and EMA guidelines.
  • Maximize Efficiency: Streamline production by preventing downtime and process inefficiencies.
  • Reduce Errors: Minimize the risk of batch failures and production errors.
  • Protect Product Quality: Guarantee product integrity and patient safety.
  • Enhance Operational Control: Provide clear, actionable data for ongoing quality improvements.
Lab worker smiling wearing lab coat and goggles
Lab worker using equipment

Validation Master Planning

A Validation Master Plan (VMP) is the roadmap for all validation efforts. A sound validation plan should outline project objectives, methodologies, documentation standards, and timelines as well as each contributor’s role and responsibilities.

Why Choose VaLogic’s VMP Services?

  • Regulatory Alignment: Our plans ensure all validation activities meet the latest regulatory standards.
  • Risk Mitigation: Identify critical control points and minimize risks early to prevent quality issues.
  • Operational Clarity: Establish clear guidelines and SOPs to reduce procedural errors.
  • Cross-Disciplinary Collaboration: Align cross-functional teams with clear validation goals and criteria.
Lab workers inspection water bottle on production

Process Validation

Process validation confirms that your manufacturing process consistently produces the intended product according to predefined quality standards. This is not a one-time task but a lifecycle approach that affirms ongoing process reliability.

Stages of Process Validation

    1. Process Design: Using data from previous development and scale-up activities, we assist with the development and documentation of your manufacturing process.
    2. Process Qualification: Our experts verify whether the designed process can produce quality products at scale.
    3. Continued Process Verification (CPV): With real-time data monitoring, we ensure the process remains in a state of control, identifying trends before they escalate.
Scientist working in a laboratory

Cleaning Validation

Contamination is one of the biggest risks in pharmaceutical and biotech manufacturing. Cleaning validation confirms that critical equipment, facilities, and surfaces are free of residues, cleaning agents, and microorganisms that could compromise product quality.

VaLogic’s Approach to Cleaning Validation

  • Develop and execute robust cleaning protocols
  • Define acceptable cleanliness limits
  • Perform verification tests using validated analytical methods
  • Simulate worst-case contamination scenarios to ensure reliable cleaning processes

Our team also offers cleanroom certification services to test and demonstrate that your controlled environments meet GMP standards.

A focused technician operating advanced laboratory equipment

Equipment Validation

Properly validated equipment is essential to maintaining a consistent, compliant manufacturing process. Equipment validation ensures that machines are installed, operated, and performing as expected.

Phases of Equipment Validation

  1. Design Qualification (DQ): We check that all equipment designs align with project requirements and industry standards.
  2. Installation Qualification (IQ): We confirm that equipment is installed correctly, including documentation of maintenance and calibration plans.
  3. Operational Qualification (OQ): We test equipment performance under defined operating conditions.
  4. Performance Qualification (PQ): We validate that equipment consistently produces products within quality parameters.
Lab workers inspection water bottle on production

Process Validation

Process validation confirms that your manufacturing process consistently produces the intended product according to predefined quality standards. This is not a one-time task but a lifecycle approach that affirms ongoing process reliability.

Stages of Process Validation

    1. Process Design: Using data from previous development and scale-up activities, we assist with the development and documentation of your manufacturing process.
    2. Process Qualification: Our experts verify whether the designed process can produce quality products at scale.
    3. Continued Process Verification (CPV): With real-time data monitoring, we ensure the process remains in a state of control, identifying trends before they escalate.
Scientist working in a laboratory

Cleaning Validation

Contamination is one of the biggest risks in pharmaceutical and biotech manufacturing. Cleaning validation confirms that critical equipment, facilities, and surfaces are free of residues, cleaning agents, and microorganisms that could compromise product quality.

VaLogic’s Approach to Cleaning Validation

  • Develop and execute robust cleaning protocols
  • Define acceptable cleanliness limits
  • Perform verification tests using validated analytical methods
  • Simulate worst-case contamination scenarios to ensure reliable cleaning processes

Our team also offers cleanroom certification services to test and demonstrate that your controlled environments meet GMP standards.

A focused technician operating advanced laboratory equipment

Equipment Validation

Properly validated equipment is essential to maintaining a consistent, compliant manufacturing process. Equipment validation ensures that machines are installed, operated, and performing as expected.

Phases of Equipment Validation

  1. Design Qualification (DQ): We check that all equipment designs align with project requirements and industry standards.
  2. Installation Qualification (IQ): We confirm that equipment is installed correctly, including documentation of maintenance and calibration plans.
  3. Operational Qualification (OQ): We test equipment performance under defined operating conditions.
  4. Performance Qualification (PQ): We validate that equipment consistently produces products within quality parameters.

VaLogic also provides calibration services, maintenance, and temperature mapping to support your business’s equipment compliance and long-term performance.

Computer System Validation (CSV)

Whenever companies transition to paperless processes and integrate advanced software into their operations, these new systems must also be validated. Computer System Validation checks that your software systems are reliable, secure, and compliant with FDA regulations.

The Benefits of CSV

  • Maintain Data Integrity: Ensure the accuracy and reliability of electronic records.
  • Ensure System Security: Protect sensitive data from breaches or unauthorized access.
  • Support Regulatory Audits: Provide a clear audit trail with documented validation.
  • Enhance Operational Efficiency: Reduce human error and automate routine tasks.

Analytical Method Validation

Accurate testing is crucial in pharmaceutical and biotech manufacturing. Analytical Method Validation confirms that your testing methods are reliable, consistent, and suitable for their intended use.

Our Analytical Method Validation Services Cover:

  • Accuracy, precision, and specificity verification
  • Limit of detection (LOD) and limit of quantitation (LOQ)
  • Linearity, range, and robustness testing
  • Method transfer validation for global facilities

When you partner with VaLogic, you gain confidence in your analytical methods knowing that your data remains trustworthy across all applications.

Work With Experts in End-to-End Validation

Validation is a complex practice that requires specialized expertise across multiple disciplines. From understanding regulatory requirements to analyzing manufacturing processes and ensuring data integrity, VaLogic brings cross-disciplinary knowledge to every project.

Ensure compliance. Minimize risks. Optimize your operations.
Contact VaLogic today to learn how our validation services can support your success.

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