Qualification and Validation

Qualifications and Validation ensure that all processes, equipment and systems function effectively and meet regulatory standards in the life sciences industry. We assist life sciences companies with their Qualification & Validation throughout the product life cycle.

Why Choose BioBoston Consulting for Qualification & Validation?

Industry-Specific Expertise

Our team of experts has extensive experience in qualifications and validations across pharmaceuticals, biotech and medical device manufacturing. We understand the regulatory requirements and we offer custom-tailored services so that both your processes and equipment meet all required standards.

End-to-end Validation Solutions

Our services cover the entire validation process, from initial planning and protocol development through execution and final reportage. We ensure that your equipment, systems and processes are completely validated to regulatory requirements, reduce risks and guarantee product quality.

Regulatory Compliance Focus

Our validation and qualification activities are always in full compliance with relevant FDA, EMEA, cGMP, ISO and ICH standards. Our approach also ensures that one hundred percent of your processes and systems are compliant, reducing the risk of any issues or product recalls.

Customized Validation Plans

We tailor qualification and validation plans according to the special requirements of your facility, equipment or process–whether it be to validate a new piece of equipment or requalifying an existing system. Those solutions are custom crafted by our team to align with both your business needs and all relevant regulatory requirements.

Comprehensive Risk Management

This includes rigorous risk assessments to identify and contain potential problems before they turn into compliance issues. We aid you in implementing Corrective and Preventive Actions (CAPA) so that your quality and compliance are assured over time.

Our Qualification and Validation Services Include:

Equipment Qualification (IQ/OQ/PQ)

Our experts provide Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) services to make sure your equipment is installed, working and functioning according to regulatory and operational requirements.

Process Validation

Conducting comprehensive process validation to confirm that your manufacturing processes consistently produce products that meet predefined quality standards.

Cleaning Validation

Ensuring that your cleaning processes effectively remove contaminants, ensuring product safety and compliance with cGMP guidelines.

Computer System Validation (CSV)

Performing Computer System Validation (CSV) to ensure that your electronic systems and software meet FDA 21 CFR Part 11 and other relevant regulatory requirements for data integrity, security, and accuracy.

Facility and Utility Qualification

Qualifying your facilities and utilities (HVAC, water systems, compressed air) to ensure they support your production environment and comply with regulatory standards.

Validation Protocol Development

Developing detailed validation protocols for equipment, processes, and systems, outlining the steps needed to achieve successful qualification and compliance.

Requalification and Periodic Review

Conducting requalification and periodic reviews to ensure that your equipment, systems, and processes continue to perform in compliance with regulatory standards over time.

Ensure Compliance with BioBoston Consulting’s Qualification and Validation Services

BioBoston Consulting’s Qualification and Validation Services provide life sciences companies with the expertise in critical areas necessary to achieve compliance, reduce risk as well as maintaining operational excellence. Let us help you achieve regulatory approval and ensure that your systems, equipment, and processes are fully validated and compliant.

Contact Us Today

Schedule a consultation to learn how BioBoston Consulting can support your qualification and validation needs and ensure the compliance and quality of your operations.