Life Sciences Quality Assurance
Vitale Scientific Associates’ (VSA’s) Life Sciences Quality Assurance group is the premier provider of expert solutions for a wide range of quality assurance needs. Obtaining reliable, microbial, biochemical, chemical, and toxicological data on which to base critical decisions is a serious, but often elusive objective for regulated entities, firms involved in or potentially affected by litigation, and businesses concerned with process integrity, product purity, product safety, and product stewardship. Ensuring that you receive reliable, valid, and compliant biological and chemical data from your contract or in-house laboratory is best achieved by a quality assurance 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 Life Sciences Quality Assurance services in a comprehensive program that defines the systems necessary to obtain reliable data.
Quality Assurance Planning
A comprehensive Quality Assurance Plan provides for the appropriate levels of quality in sampling efforts and laboratory conduct of reliable chemical, microbiological and biochemical studies. VSA has prepared program-wide and project-specific QAPs by carefully documenting the sampling, test material handling, and testing quality assurance and quality control procedures necessary to achieve project data quality objectives. We avoid the pitfalls – such as delays, excessive costs, and damage to your firm’s public image and relationship with regulators – that can result from insufficient quality planning.
Corporate Laboratory Programs
A well-developed corporate laboratory management program improves technical quality, customer service, laboratory consistency, and cost efficiency while providing a mechanism to simplify contracting and in-house management practices. VSA developed and currently maintains laboratory programs for numerous clients, many of whom realize a 20 – 30% annual savings in testing costs as a result of implementation. Our professionals evaluate and assess client needs, including in-house laboratory capabilities and practices. We also identify candidate external laboratories where appropriate, perform on-site laboratory audits, oversee performance evaluation studies (e.g., proficiency testing schemes), and develop comprehensive technical specifications so that all of your laboratories are adhering to a unified approach for planning and implementing data defensibility and traceability. We provide independent evaluation of proposals and provide help-desk and on-site coaching for your in-house and contract laboratories needing assistance in meeting the technical specifications.
Our Life Sciences 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 17025 requirements. Laboratory audits are an important tool for assessing liabilities that may arise from using in-house and commercial laboratories.
Test 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 sample collection, handling, and testing data are usable for their intended purpose and will withstand rigorous litigation proceedings or agency scrutiny.
Methods Evaluation and Development
Test materials, modes of exposure, mechanisms of toxicity, factors affecting sterility, and emerging biochemical studies often cannot be evaluated by standardized methods and may require special handling and test protocols to establish validity and reliability. Our scientists evaluate and develop protocols to provide solutions for non-routine testing often altering the design or implementation of standardized methods to achieve a project-specific requirement or by developing a new protocol for a specific scientific need. Given VSA’s focus on quality assurance and quality control, we develop protocols of well documented validity, accuracy, precision, sensitivity, and specificity.
Litigation Support Services
VSA’s scientists have provided scientific quality assurance litigation support 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 provide third-party damage claims review, including cost recovery claims analysis, and help clients develop a technical basis to address unrealistic damage claims.