Claim Substantiation Quality Management

Consumer Product Testing Focused Quality

With our focus on transparency and ethical practices, it was necessary to develop a completely custom tailored Quality Management System (QMS) from the ground up. Our QMS is a hybrid of Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), and Good Laboratory Practices (GLP) where applicable, which effectively allows us to straddle the realm in between manufacturing and product compliance.

GMP, GCP, GLP Hybrid Quality Management

Our studies are focused primarily on ICH GCP Guidelines, with a secondary lens on FDA GMP (as a result of our Registration), and tertiary GLP applications that focus on sample handling and environmental control.

Our Claim Substantiation Quality Policy

Providing accurate and transparent clinical support for the personal care sector while:

• Maintaining a relevant current understanding and implementation of respective regulatory requirements and industry practices
• Continuously reviewing and improving our workflow based on internal/external audits and sponsor and regulatory feedback

FDA Registered, and Inspected

VCS registered with the FDA as an Analytical Testing laboratory prior to opening our doors in July 2019. We completed our first multi-day site inspection August 24th, 2020 and we’re proud to note that we had no major findings of any kind.

In the competitive laboratory space, it is actually a choice to register with the FDA in the cosmetic/skincare area. . . Due to our commitment to excellence we don’t believe it was an option.

As a registered laboratory, we are capable of handling drug related claims and clinical studies alongside basic skincare, haircare, and beauty products. Our site is officially listed as a Current Drug Establishments Current Registration Site on the FDA’s database, which is accessible here:
https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm

Training in Skincare Clinical Research

Our continuous improvement policy relies heavily on employee and management training. Of primary concern are Good Clinical Practices certifications, HIPAA training, and data protection/privacy training for all employees across the organization.

Our training records are available upon request, and we strive to ensure that we meet and exceed client facing expectations.

Quality Control in Claim Support

Because VCS was developed from the ground up, we were able to take a unique approach to our quality system. All of our current documentation is digitally controlled in a secure, 2 factor protected cloud based system controlled through Microsoft’s security suite.

Accordingly, all of our Standard Operating Procedures (SOPs) are available digitally through encrypted email transmission upon sponsor request.

Our SOPs are reviewed annually or more frequently as needed, and all of our controlled versions are restricted based on user level access.

Ethical and Accurate Quality Assurance. . . Every Time

Our Quality Team is involved with the study design process from concept through completion. Aside from standard documentation control, pre-study meetings include quality management team members, and secondary controls are implemented spot checking data collection of study processes such as Informed Consent and Protocol Development.

Consumer Product Safety and Privacy Protection

Quality Management goes hand in hand with Data Protection and Privacy. Our Panelists are instrumental to our ability to operate in the clinical realm, and our training ensures that their personal information is private and confidential.

With the help of our RealTime Clinical Trial Management System and our training repertoire, you can rest assured that your data and our panelists are well guarded, safe, and secure.

Clinical Studies Quality during COVID-19

2020 brought with it a very unique set of challenges, and our management team got to work developing a new set of SOPs to deal with some of the added difficulties along with implementing lengthy secondary revisions and improvements. Our COVID-19 SOPs are extensive, and they have been audited and reviewed by third party sponsors and professional quality control personnel.

For a detailed list of our Standard Operating Procedures or to request review of any specific documentation, please contact us directly.