Chemistry Quality Assurance
Obtaining reliable analytical data on which to base critical decisions is the ultimate goal for regulated entities, parties involved in or potentially affected by litigation, and businesses concerned with process integrity, product purity, product safety and product stewardship. Vitale Scientific Associates’ (VSA’s) Chemistry Quality Assurance group is the premier provider of expert solutions developed to meet a wide range of chemistry quality assurance needs.
Ensuring that you receive compliant and usable analytical data from your contract or in-house laboratory is best achieved by a process that is put in place over time. While you will see improvements by implementing parts of the process, the greatest benefits are realized by integrating all of VSA’s Chemistry Quality Assurance services in a comprehensive program that defines the systems necessary to obtain reliable data.
Corporate Laboratory Programs
A well-developed Corporate Laboratory Program improves technical quality, customer service, laboratory consistency, and cost efficiency while providing a mechanism to simplify contracting practices. We have developed (and are currently maintaining) laboratory programs for numerous clients, many of whom realize a 20 to 30 percent annual savings in analytical costs. Our professionals assess your needs, identify candidate laboratories, perform on-site laboratory audits, oversee performance evaluation studies, and develop comprehensive technical requests for proposals and evaluate laboratory responses.
Quality Assurance Planning
A comprehensive Quality Assurance Plan leads to consistent quality of sampling efforts and generation of reliable analytical data. VSA has prepared project-specific QAPs by carefully documenting the sampling and analysis quality assurance and quality control procedures necessary to achieve project data quality objectives. We avoid the pitfalls – such as delays, excessive costs, and jeopardizing an industry’s relationship with regulators – of submitting a deficient quality assurance plan.
Our Chemistry Quality Assurance Department has performed hundreds of audits of laboratories in North America, South America, and Europe on behalf of industrial and governmental clients, industry groups, and law firms. These rigorous audits may exceed GLP, OECD, regulatory-based and ISO Standard 17025 requirements. Laboratory audits are an important tool for assessing liabilities that may arise from using in-house and commercial laboratories.
Analytical results that are generated from sampling events become the basis for assessments and process improvement, product release, recall and retain decision-making processes. The degree to which data are valid can make the difference between a correct assessment and an unnecessary recall or product contamination event. We examine the sample collection records and the laboratory raw data to determine if a particular analysis conforms to client, method, regulatory agency specifications and to the rigors required for scientific validity. Our data validation offers justification and reassurance that analytical data are usable for their intended purpose and will withstand rigorous litigation proceedings or agency scrutiny.
Methods Evaluation and Development
Unique chemicals of concern in many processes often cannot be analyzed for by standardized methods or may require special preparation and analysis procedures, low detection limits, or modifications to reduce interferences. Our chemists evaluate and develop analytical methods to provide solutions for non-routine chemical analysis by altering the design of standardized methods to achieve a project-specific requirement or by developing a new analytical method for a specific chemical or matrix. Because of our focus on quality assurance and quality control, we develop analytical methods of well documented validity, accuracy, precision sensitivity and selectivity.
Litigation Support Services
VSA scientists have provided chemistry and quality assurance litigation support services to private industry, insurance companies, and legal firms. Our technical review of investigation and project documents provides litigation strategies for questioning opposing witnesses on critical technical issues. We have provided third-party damage claims review, including cost recovery claims analysis, to help clients develop a technical basis for addressing unrealistic damage claims.
Regardless of your business, vendors and suppliers play a key role in your success. However, managing and administering the supply chain quality of vendors’ products and services can be an expensive, time consuming, and highly technical task. Let VSA scientists support you in your role by providing third party supplier management services.
Our consultative approach results in an accurately budgeted, organization-specific solution. The services we offer include:
- Vendor Technical Specifications Manual development
- Vendor Selection Support
- On Site Audits
- Product Specifications
- Quality Systems
- Control of Test Equipment
- Quality and Source of Raw Materials
- Control of Non-Conforming Product
- Corrective Actions
- Certification/Accreditation Review
- Reporting and Trend Analysis
- Licenses and Permits
- Validation Certificates of Analyses for Finished Products
- Record Maintenance
- Handling, Storage, Packaging, and Delivery