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Quality Auditing Services
The ISO 9001 Standard mandates internal audits of a company’s Quality Systems and requires that organizations exhibit the capability to consistently manufacture products that meet regulatory standards. Our Quality Auditing services encompass an in-depth evaluation of your organization’s validation and manufacturing processes, Quality Systems, and Quality Control processes to ensure alignment with regulatory standards. The outcomes of our Quality Auditing process, along with our recommended remedial actions, ensure your organization’s Quality Systems operate in accordance with compliance standards while fostering a culture of continuous improvement.
Quality Assurance Services
Quality Assurance (QA) holds crucial significance across all phases of the manufacturing process, from incoming raw materials to the final production stages, ensuring products are consistently manufactured meeting stringent quality standards that are suitable for patient use in terms of efficacy, quality, and safety. CompliFirst recognizes the utmost importance of patient safety, serving as the core motivation behind our approach to Quality Assurance. Our range of QA services include client support in various areas such as GMP document review, risk assessments, on-the-floor QA oversight during operations, batch record review and batch disposition, change control, investigations, and CAPA implementation, among other vital services.
Microbiology Services
CompliFirst provides a variety of Microbiology services, such as validating test methods (e.g., sterility and microbial limits testing), generating protocols, designing EMPQs, establishing EM programs, designing disinfectant efficacy studies, performing microbial risk assessments, developing microbial control strategies, and more. Our Microbiology services are harmonized with relevant pharmacopeia and regulatory standards, ensuring the highest standards of industry compliance for our clients.
Laboratory Control Services
CFR Part 211.160 of the Code of Federal Regulations mandates pharmaceutical and biotech firms to set specifications, standards, sampling plans, test procedures, and laboratory controls that reflect scientifically sound practices. During FDA laboratory inspections, a key focus is on examining laboratory operations and raw data to evaluate your organization’s compliance with cGMP. Our laboratory control services include evaluating SOPs, analytical procedures, validated test methods, raw laboratory data, and laboratory records.
Quality Risk Management Services
Our Quality Risk Management (QRM) services involve the identification, analysis, and evaluation of risks within your company’s GMP processes and Quality Systems. After identifying potential risks, we conduct a thorough risk analysis and provide recommendations to mitigate those risks to acceptable levels by implementing effective control measures. Utilizing standard risk assessment tools such as Failure Mode and Effects Analysis (FMEA) and Hazard Analysis and Critical Control Points (HACCP), our QRM services align with ICH Guideline Q9, ensuring risk management solutions in line with industry standards for our clients.
Compliance Assessment and Remediation Services
CompliFirst’s services for compliance assessments and remediation involve assessing your company’s current procedures, validated processes, GMP processes, and Quality Systems against prevailing regulatory standards to gauge your organization’s compliance status. The findings from the compliance assessment drive the development of remediation strategies to resolve any compliance gaps identified during the assessment.
Quality Investigation Services
We offer expertise in conducting comprehensive investigations of non-conformance deviations, ensuring the application of a robust level of root cause analysis (RCA) throughout the investigative process. Our Quality Investigation Services employ a methodical approach using standard RCA tools such as Ishikawa Diagrams (Fishbone Diagram) and 5 Whys Analysis, coupled with a Corrective Action and Preventative Action (CAPA) methodology, leading to process improvements for our clients.
Technical Writing Services
CompliFirst provides an array of technical writing services tailored for GMP documents. Our expertise includes developing or revising your company’s Standard Operating Procedures (SOPs), training materials, validation protocols and reports, logbooks, laboratory protocols and reports, test method documents, batch records, and other document types upon your request.