A Network of Vetted & Trusted Clinical Support Vendors Help Validate Your Claims
Our partners help support our clinical research by providing industry leading solutions for compliance, marketing, and branding opportunities. We’re proud to partner with some of the best in the industry.
DocuSign CFR 21 Part 11 Compliant Signatures
In 21 CFR Part 11, the Food and Drug Administration (FDA) establishes its requirements for electronic records and signatures. These regulations, which apply to all FDA program areas, were intended to permit the widest possible use of electronic technology, compatible with FDA’s responsibility to protect the public health.
DocuSign solutions are used by pharmaceutical and medical device companies to meet a range of compliance requirements, including those set forth in the Code of Federal Regulations Title 21 Part 11.
We have a complete guide to CFR Part 11 and electronic signatures with examples of how DocuSign solutions satisfy requirements.
Here we’ll summarize subpart C of CFR Title 21 Part 11, which outlines requirements related to the use of electronic signatures.
What is 21 CFR Part 11?
Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration regulations on electronic records and electronic signatures.
The term “Part 11” applies to records in electronic form that are created, modified, maintained, archived, retrieved, transmitted or submitted, under any records requirements set forth by the FDA regulations/predicate rules.
Life science organizations and device manufacturers regulated by the FDA are required to follow the Code of Federal Regulations Title 21 Part 11.
The FDA also issued a guidance paper “Part 11, Electronic Records; Electronic Signatures — Scope and Application” to provide further clarification on electronic records and electronic signatures.
What Does 21 CFR Part 11 Require Related to Electronic Signatures?
The FDA allows electronic signatures to be used in place of pen and ink signatures on paper documents so that business can be conducted digitally. In order to be compliant electronic signatures must include:
- The printed name of the signer
- The date and time the signature was executed
- What are the other requirements for electronic signatures?
- Digital adopted signature
- The meaning of the signature (labeled “signing reason”)
- A unique user ID
Each electronic signature must be unique to one individual and not reused by, or reassigned to, anyone else. Subsection 11.100(a)
The identity of the individual must be verified before establishing, assigning, certifying or otherwise sanctioning the individual’s electronic signature, or any element of such electronic signature. Subsection 11.100(b)
Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be legally binding equivalent of traditional handwritten signatures. Subsection 11.100(c)
Persons using electronic signatures must, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer’s handwritten signature. Subsection 11.100(c.2)
Electronic signatures that are not based upon biometrics must employ at least two distinct identification components such as an identification code and password. Subsection 11.200 (a)(1)
When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing must be executed using all electronic signature components. Subsequent signings must be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual. Subsection 11.200 (a)(1)(i)
When an individual executes one or more signings not performed during a single period of controlled system access, each signing must be executed using all of the electronic signature components. Subsection 11.200 (a)(1)(ii)
The uniqueness of each combined identification code and password must be maintained such that no two individuals have the same combination of identification code and password. Subsection 11.300(a)
Identification code and password issuances must be periodically checked, recalled or revised (e.g., to cover such events as password aging). Subsection 11.300(b)
Loss management procedures must be followed to electronically deauthorize lost, stolen, missing or otherwise potentially compromised tokens, cards and other devices that bear or generate identification code or password information. The system must issue temporary or permanent replacements using suitable, rigorous controls. Subsection 11.300(c)
The system must use transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use. Subsection 11.300(d)
A procedure must be in place for initial and periodic testing of devices such as tokens or cards that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner. Subsection 11.300(e)
DocuSign’s Life Sciences Modules for Part 11
The good news is that modern cloud technologies are not only easier to use and implement but can be far simpler to validate. Life sciences leaders can make technology investments that support their current workflow and set them up for future growth—while choosing tools that meet requirements for regulatory compliance.
The DocuSign Part 11 module is a product enhancement available for DocuSign’s life science customers. It includes additional security and controls, resulting in a different signing experience relative to non regulated use cases.
The DocuSign Life Sciences Modules contains capabilities designed for documents and approvals regulated by 21 CFR Part 11, including:
- Prepackaged account configuration
- Signature-level credentialing
- Signature-level meaning (signing reason)
- Signature manifestation (printed name, date/time and signing reason)
RealTime CTMS for Managing Cosmetic Testing Subject and Participant Database
Realtime provides a cloud based Panelist Database management system that is HIPAA compliant and fully custom tailored to different types of clinical studies. Protected Health Information (PHI) is stored securely behind a 2 factor authenticated system and restricted by user access level to ensure compliance across all levels of data protection.
RealTime allows VCS to create customized digital studies and hand select panelists based on past history, demographics, and underlying conditions, collectively called their “Social History.” Database records include photos for visual qualification and assessment of underlying conditions as specified by individual sponsor clientele.
Communications with panelists are streamlined, and reminders for upcoming visits are automatically setup during digital study creation. RealTime dramatically improves efficiency through automation and clear organizational structure.
RealTime SitePAY for Secure, IRS Facing Transparent Subject Payment
RealTime also provides a custom tailored solution for panelist payout which is fully digital and IRS compliant. Panelist total compensation is automatically tracked throughout the year via unique Medical Record Number (MRN) and payout is completed through individualized and token secured debit cards.
SitePAY eliminates the need for cash and checks onsite, dramatically reducing the risk of theft and fraud. It also provides a secondary quality check to ensure panelists are not “double dipping” on clinical studies, and that all tax related compensation guidelines are abided by on a continuous basis.
Microbiome Claim Support Powered by Sequential Bio
Microbiome-Conscious Product Development and Clinical Testing
As the benefits of the microbiome become better understood, interest in developing microbiome-friendly personal care products has increased. As a result, the personal care industry is moving towards creating microbiome-conscious cosmetic and skincare products. In the past, skincare developers often focused on their product’s ability to kill the bacteria living on the skin’s surface, with little-to-no concern for the “good” bacteria also residing there. A growing body of research supports the benefits of the microbiome, including its role in skin barrier maintenance and wound healing. It is no longer sufficient to create skincare products that kill the “bad” bacteria; you must also create products that support the “good” bacteria.
Validated Claim Support has partnered with Sequential Bio to facilitate microbiome analysis and improve the development of cosmetic skin care products. By combining Validated Claim Support’s analytical expertise and Sequential's expertise in genomics, we provide a unique value proposition allowing for microbiome claim substantiation.
DNA Sample Collection for Skincare and Cosmetic Claims
A proprietary in vivo method for analyzing the effects of personal care products on the skin microbiome is used for sample collection via a noninvasive skin patch. Sequential Bio will extract/amplify the DNA, create a DNA library, and sequence the DNA using state-of-the-art genomic technologies. After the study, the data is compiled into a comprehensive, easy-to-read report, providing actionable insights for formulators and research scientists to incorporate into their product development pipeline.
The partnership between Sequential and VCS allows for custom research studies, tailored claim support, and analytics packages. Using cutting edge technologies, microbiome analysis can be accessible for any size organization.
Sequential Bio enables personal care product developers to validate claims regarding their product’s impact on the microbiome. Claim validation can enhance product development/marketability and help a brand stand out against the competition.
Claims include (but may not be limited to):
- “Certified to maintain the Microbiome”
- Microbiome-Friendly
- Eliminates the Root Cause of Odor
- Supports a Natural Skin Balance
- Will not upset Skin Homeostasis
- Will not disrupt the Microbiome
Claim Support Validation Techniques
- Shotgun sequencing
- 16s Sequencing
- Next Generation Sequencing
- qPCR analysis
More Information on Sequential Bio
TRI Princeton For Haircare Analytical Claims Partnership
The Textile Research Institute (TRI) Princeton is an independent, non-profit, scientific research and education organization. Over the years, TRI has provided research solutions to a wide variety of domestic and international industrial companies, governmental organizations, and academic institutions.
TRI was created by the American government in 1930 to support the country’s textiles industry. The institute founded the Textile Research Journal and was a leader and innovator in the textiles area for many years, forging close links with Princeton University.
In the 1980’s, TRI gradually moved its focus from textile fibers to hair fibers. Today, TRI is a leading-edge, global center for cosmetic science research, focused mainly on the hair care and skin care categories, although we do still do some work on textiles. As well as publishing original research, TRI organizes many conferences and educational courses. TRI also provides high-quality contract testing services to companies. TRI’s test reports are held in high regard by scientists and regulators around the world.
TRI has a Board of Trustees, which is responsible for senior appointments and checking the finances. The Trustees also use their considerable business and scientific experience to help guide TRI in the right direction and to keep the institute focused on the needs of industry.
TRI is based in Princeton, New Jersey. Our facilities are set in the middle of 18 acres of woodland, 2 miles from the center of Princeton and overlooking Lake Carnegie. Our original laboratories, library and seminar rooms are based in a converted manor home built in 1913. More up to date facilities are provided in an adjacent laboratory building.
TRI's Research First Mentality for Haircare Claim Support
By specializing in a combination of fundamental and applied science, we are recognized leaders in the personal care industry and have pioneered new methods and techniques to drive innovation in the field, set new standards by which the industry can follow, and raise the scientific bar in our industry to help maintain industry regulations and formats for product development and launches.
From College Interns to Post-Doctoral Fellows and Industry Professionals, TRI is Committed to Educating Today's and the Next Generation of Scientists
Through their Professional Education Program, along various student employment opportunities, we provide the industry and the scientific community with a solid foundation of educated, motivated professionals. By contrast, our Scientific Conferences are renowned for their technical standing and for bringing together today’s scientists with tomorrow’s innovators to bridge the gap of learning and creativity.
Expert Clinical Grading
Trained graders score visible changeSupports claims like “Clinically proven to reduce the appearance of fine lines and wrinkles”
Learn more →Biomarkers and Microbiome
Tape strips, swabs and collectionsSupports claims like “Microbiome friendly” and “Won’t disrupt the skin’s natural microbiome”
Learn more →Biophysical Instrumentation
Hydration, TEWL, elasticity, colorSupports claims like “Hydrates by up to 87% in as little as one use”
Learn more →Peer-Reviewed Writing
Clinical and scientific publicationsScientifically validated study summaries for publication in peer-reviewed medical journals
Learn more →Before and After Photography
Controlled, reproducible clinical imagingSupports claims like “Up to a 44% reduction in redness in as little as 2 weeks”
Learn more →Consumer Perception
Panelist questionnaires and self-assessmentSupports claims such as “97% of women agreed their skin felt smoother and more supple”
Learn more →
Scientist.com for Cosmetic Testing Service Industry Listings
VCS is proud to be a Top Supplier on Scientist.com, the world’s largest AI-powered marketplace for medical and skincare research.
By providing turnkey service agreement review and management along with invoice purchasing to mitigate lengthy accounts receivable turnover, Scientist.com helps allow Validated Claim Support to compete with the largest multinational Clinical Research Organizations on the planet.
Partners include small and large pharmaceutical and biotechnology companies, crop science companies, cosmetic manufactures, Contract Research Organizations (CROs) like Validated Claim Support, government research institutes, university core facilities, academic researchers, and citizen scientists alike.
Visit Validated Claim Support’s Scientist.com profile here: https://app.scientist.com/providers/validated-claim-support
Skinobs: Clinical Testing Listings and Support Around the World
Skinobs.com provides an online listing for laboratory services as well as a means for multilingual publications about ongoing skincare happenings and clinical advances. Skinobs represents a platform dedicated to up-to-date information about current methodologies and international testing laboratories.
VCS is proud to be a member of the Skinobs team. You can review one of our most recent articles here:
Last Article Published: The Pandemic Paradigm for Claims
Summary:
As some businesses gear up to reopen with at least partial “on-site” attendance, it’s very important to look ahead and begin to assess what additional challenges the COVID-19 shutdown will have on the Personal Care industry throughout reopening. With all of the essential on-site only and distancing requirements, shipping delays, formulation setbacks, and awkward zoom meetings that have arisen from the stay at home orders, it is more important than ever to remain vigilant and proactive. In many cases this will lead to some compromises when it comes to claim support and consumer testing, and it’s extremely important to consider study designs that will be the best fit for the global consumer as well as the labs who help you support your claims.
As some businesses gear up to reopen with at least partial “on-site” attendance, it’s very important to look ahead and begin to assess what additional challenges the COVID-19 shutdown will have on the Personal Care industry throughout reopening. With all of the essential on-site only and distancing requirements, shipping delays, formulation setbacks, and awkward zoom meetings that have arisen from the stay at home orders, it is more important than ever to remain vigilant and proactive. In many cases this will lead to some compromises when it comes to claim support and consumer testing, and it’s extremely important to consider study designs that will be the best fit for the global consumer as well as the labs who help you support your claims.
Visit our profile on Skinobs here: https://skinobs.com/labo.php?id=222
Happi Magazine/Rodman Media for Personal Care Testing News
Happi Magazine is an industry staple in the personal care and beauty space, and their unique editorial style provides a breath of fresh air as developments occur throughout the industry.
Happi’s coverage of the global household and personal care products industry is the best in the business. For over 50 years, their editors, correspondents, and technical writers have ensured accurate and well documented articles hit the press in a timely fashion. In 2020, they dramatically expanded their online presence and maintain ongoing digital editions and the ever popular yearly Corporate Profiles [link]
Happi was kind enough to feature Validated Claim Support shortly after our opening [link]
In Cosmetics for Skincare and Personal Care Ingredient Tradeshows
In Cosmetics is the world’s largest tradeshow and exhibition supplier for the skincare, beauty, and personal care industries, and our team has been working with them for over 10 years. With events in New York, Europe, Thailand, Korea, Latin America, and China, In Cosmetics provides a truly global network and reach that allows exhibitors and visitors to connect with companies from all over the world.
VCS is proud to support and exhibit at many of the major international exhibitions that In Cosmetics hosts. Please check out some of our Exhibitor Details for In Cosmetics Barcelona below:
Society of Cosmetic Chemists for All Local Clinical Testing
Validated Claim Support staff maintain active memberships with the NYSCC and participates in numerous global Society of Cosmetic Chemists events annualy. The SCC is a great source of both educational programs and industry events that allow suppliers and manufacturers to connect and synergize.
The NYSCC was established in 1955, and as the Society of Cosmetic Chemist’s largest chapter world wide it has a very pronounced presence on the global scene. The NYSCC provides unparalled access to networking events and industry talks and seminars alike, and the Supplier’s Day show is one of the largest worldwide events in the industry. VCS is proud to be a multi-year exhibitor at the NYSCC Supplier’s day.
Institutional Review Boards for Drug Product Testing
Allendale IRB (Regulatory and Technical Associates)
Regulatory and Technical Associates, Inc. (RTA) is a toxicology, preclinical drug and medical device development, and regulatory affairs consulting company that specializes in a wide range of development activities. Our consultants are Board Certified in toxicology, regulatory affairs, and safety and have years of experience in toxicology, preclinical drug and medical device development, and regulatory affairs. We work with domestic and international clients and provide superior consulting services.
We focus our attention on the needs of our clients in the pharmaceutical, medical device, cosmetic, food, consumer product, chemical, and petroleum industries. We are recognized as a leading expert in women’s reproductive health and are registered as a US Agent with the FDA. Our toxicology, preclinical drug and medical device development, and regulatory activities focus on the safety evaluation of new and established products. RTA has the necessary experience in toxicology, preclinical drug development, and regulatory affairs to assist our clients’ address the product development safety and regulatory issues that directly impact their ability to bring their products to market.
RTA routinely prepares regulatory submissions for the FDA and other worldwide regulatory agencies. These include INDs, IND Annual Reports, NDAs, CTDs, IDEs, 510(k)s, and PMAs, Food Additive Petitions, and GRAS determinations.
Drug and medical device product development is a rigorous, labor-intensive, and time-consuming process. RTA provides you with the experience, support, and consultation in toxicology, preclinical drug and medical device development, and regulatory affairs necessary to bring your products to market.
Advarra (formerly IntegReview)
With Advarra’s One-Touch Collaboration, your research team benefits from an outstanding service experience, a single point of contact, and consistent reviews from our integrated, single IRB. It is our goal to proactively facilitate your study experience and deliver unmatched support. Benefits include:
- One central point of contact who knows you and your study(ies)
- One stream of clear, coordinated communications
- One study startup process for all sites, whether an institution or an independent research site
- One set of forms, processes, and document templates for clear document management
- Unlike other IRBs, Advarra offers a truly single IRB review and delivers white-glove service to our clients. We also guarantee an outstanding, streamlined process from submission to final documentation.
Typically, Advarra can perform a full board review of a new protocol and informed consent for a multisite trial within 4 business days. Expedited review of a new minimal risk protocol and informed consent can be completed within 2 business days or even less depending on the urgency of your need. Advarra also provides rush review services to help you meet demanding timelines. As your partner, Advarra is committed to getting your trial started on time and helping you reach critical study milestones quickly.
About Validated Claim Support
Validated Claim Support’s experienced clinical testing team has pooled their vast claim support knowledge in the skincare trials and cosmetic product efficacy space to develop a unique and highly personalized strategy. We provide a distinctive service category that is particularly hard to find: highly personalized efficient service and accountability at an affordable price.
