Pharmaceutical Validation Services

Comprehensive Validation Support Across the Product and System Lifecycle

Validation is the cornerstone of product safety and regulatory compliance in the pharmaceutical industry. At MCS Associates, we deliver science-driven validation services that meet global GMP expectations while supporting operational efficiency and product quality. From protocol design to final report, we ensure every phase is documented, defensible, and audit ready.

MCS Associates offers end-to-end validation services tailored to the evolving needs of pharmaceutical, biologics, natural health product, and medical device manufacturers. Our team delivers expert support in all major areas of validation, including:

• Cleaning Validation
• Analytical Method Validation
• USP Microbiological Suitability Studies
• Process Validation (Stages 1–3)
• Computer System Validation (CSV)

With a lifecycle-based, risk-managed approach grounded in ICH, FDA, Health Canada, and EU guidelines, we help clients establish and maintain robust validation programs that ensure product quality and regulatory compliance.

Whether you’re qualifying a new process, validating critical software, or remediating post-inspection gaps, our validation solutions are pragmatic, structured, and defensible.

We develop and execute cleaning validation protocols in compliance with FDA, EU Annex 15, Health Canada GUI-0028, and PIC/S PI 006. Our services are designed to mitigate contamination risk and demonstrate cleaning effectiveness across manufacturing operations.

Our cleaning validation services focus on minimizing product cross-contamination and ensuring reproducible cleaning results. Key criteria include:

• MACO (Maximum Allowable Carryover) calculations
• Worst-case product selection strategies
• Swab and rinse recovery testing
• Visual inspection limit establishment
• Hold time studies and cleaning cycle development
• Globally aligned documentation packages

Applicable Regulations: FDA (Guide to Inspections: Validation of Cleaning Processes (7/93), EU Annex 15 and Guideline on setting health-based exposure limits, Health Canada Cleaning Validation Guide GUI-0028, PIC/S PI 006 (Recommendation on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, and Cleaning Validation)

Aligned with ICH Q2(R1) and USP <1225>, we validate analytical methods for raw materials, intermediates, and finished products across different dosage forms.

Our abilities include:

• Full validation for accuracy, precision, linearity, range, LOD/LOQ
• System suitability, robustness, and reproducibility assessments
• Support for both compendial and non-compendial methods
• Stability-indicating method validation

When using USP microbiological methods (e.g., <61>, <62>, <85>, <621>), regulators require confirmation that the method works with your specific matrix and conditions.

We provide:

• Matrix interference and specificity studies
• Microbial recovery and sterility assessments
• System suitability verification
• Justification and documentation for method modifications

Following FDA, EMA, and ICH Q8–Q11 guidance, MCS Associates supports all three stages of the process validation lifecycle:

• Stage 1: Process Design – Defining QTPP, CQAs, CPPs, and control strategies
• Stage 2: Process Qualification – IQ/OQ/PQ execution and validation batch oversight
• Stage 3: Continued Process Verification (CPV) – Ongoing monitoring of process parameters and product trends

We also assist with technology transfers, scale-up validation, and remediation strategies following regulatory inspection.

As digital platforms become essential in pharmaceutical manufacturing and quality systems, validating computerized systems is critical for regulatory compliance and data integrity.

We apply GAMP 5 methodologies in alignment with 21 CFR Part 11, EU Annex 11, and ALCOA+ principles to validate:

• Laboratory Information Management Systems (LIMS)
• Quality Management Systems (QMS)
• Manufacturing Execution Systems (MES)
• ERP platforms and cloud-based/SaaS applications
• AI-assisted and custom software tools

Integrated Quality Systems Support

CSV doesn’t live in a silo. That is why we integrate our computer system validation strategies directly into your pharmaceutical quality management system (QMS).

We embed validation activities directly into your Pharmaceutical Quality Management System (QMS), ensuring compliance is sustainable, repeatable, and audit-friendly.

Our team helps you:

• Align validation SOPs with internal QMS workflows
• Train staff in GAMP 5 and GMP validation best practices
• Centralize validation deliverables for traceability and inspection readiness
• Manage validated change control processes and deviation investigations

Future-Proof Your CSV Strategy with MCS Associates

Validation is evolving. With the rise of cloud-based platforms, AI/ML integration, and digital transformation in pharma, it’s no longer enough to validate static systems. You need a partner who understands how to validate innovation.

MCS Associates supports CSV for:

• SaaS and IaaS-based systems
• Custom software and in-house builds
• Data migration and digital transformation projects
• AI-assisted diagnostics, digital therapeutics, and eCTD systems

Our approach is not just to validate your technology but to future-proof your compliance.

• Specialists in FDA, ICH, EU, and Health Canada regulatory frameworks
• Experience across oral, injectable, topical, biologic, and natural health products
• Practical and cost-effective validation strategies tailored to client needs
• Proven performance in new product launches, regulatory remediations, and digital modernization
• Flexible delivery models: on-site, remote, or hybrid

Whether you’re launching a new product, upgrading your facility, or remediating after an audit, MCS Associates provides validation solutions that reduce risk, satisfy regulators, and support long-term quality.

Contact us today to book your next cleaning, analytical, or process validation consultation.

Let’s Build Validation That Works

Whether you’re facing your first validation effort or overhauling enterprise systems across global sites, MCS Associates brings the technical depth, regulatory fluency, and GAMP 5 discipline you need.

Get in touch to learn how our computer system validation services can streamline compliance, mitigate risk, and keep your systems audit-ready from day one.

Ready to Validate with Confidence?

Whether you’re validating a new product, implementing a digital platform, or responding to Health Canada or FDA findings, MCS Associates delivers expert, inspection-ready validation services that reduce risk and improve quality outcomes.

Contact us today to discuss your next validation project.