- â21 CFR Part 11 contracts capability key to the win
- Enterprise integration of advanced E Signature and Digital Document Compliance
- Showcases Make in India Make for the World credentials
MSB Docs, the leading global disrupter in enterprise-grade customised eSignature and Smart Document Compliance solutions, today announced the successful implementation of its solutions at a California CRO organisation. The organisation is a contract research organization (CRO) providing Biostatistics, Data Management and SAS Programming to pharmaceutical, biotechnology and medical device industries worldwide. With these customer wins, MSB Docs further strengthens its dominance of the pharma and CRO sector for eSignatures & Digital Smart Document compliance solutions. MSB Docs already works with 8 out of the leading 10 Pharma organisations globally.
Highlighting the business differentiation, Srini Dokka, Global Sales Head, MSB Docs, said, “MSB Docs’ robust 21 CFR Part 11 contracts compliance capability was key to winning the mandate. Life Sciences manufacturers need to adhere to strict guidelines laid out by governing bodies, including the Food and Drug Administration (FDA) since pharmaceutical products and medical devices directly influence the health and safety of the customer.”
The FDA set up 21 CFR Part 11 compliance as a more comprehensive code of regulations to govern the Pharmaceuticals and Life Sciences industry. 21 CFR Part 11 describes Part 11 of Title 21 of the Code of Federal Regulations on electronic records and electronic signatures as stated by the United States FDA. The term “Part 11” applies to documents in digital form that are created, customized, maintained, archived, recovered, transferred, or submitted under any record requirements stated by the FDA regulations/predicate policies.â¯Besides digital records, this code also incorporates images, audio files, source code, and videos. Eventually, 21 CFR Part 11 allows suppliers in the life sciences industry to avoid a lot of complex paperwork management.
FDA allows the use of electronic signatures in place of wet ink signatures on paper records to ensure that a business can be carried out electronically. eSignatures must consist of the following to be compliant:
- Every eSignature must be unique for an individual and shall not be reused or reassigned to another individual.
- The signer’s identity must be validated before establishing, assigning, certifying, or approving their electronic signature or any element of such eSignature.â¯
- Individuals using eSignatures must, upon company demand, provide additional certification or testimony that a particular electronic signature is the lawfully binding equivalent of the signer’s wet or handwritten signature.
- Electronic signatures must use a minimum of two unique IDs, such as an identification code and a password, if not based on biometrics.
- Uniqueness must be maintained for each combined identification code and password, and no two signers must have the same identification code and password combination.
- The system needs protection for every transaction to avoid unauthorized usage of passwords or ID codes and to promptly detect and report any attempts at their unauthorized use.
Included within MSB’s Digital Smart Document Solutions are hybrid signature solutions in the form of digital and electronic signatures. In addition, MSB provides region-specific signature modules. For instance, business entities in India can get an Aadhaar-based signature solution with MSB Docs. To ensure that all documentation processes are conducted in the most secure manner, the company offers services such as Tamper proof audit trail, document collaboration using Team Room and varied workflow & document templates. Furthermore, there is a proprietary search algorithm in place for seamless identity and background verification, which comes handy in functions such as onboarding a new client. Other offerings of the company include legally compliant stamping feature, frictionless on-demand web form submission, text tags, tax insurance and license validation, etc.
About MSB Docs
MSB Docs (msbdocs.com) is the leading disrupter in enterprise customised eSignature and Smart document solutions, helping large and small organisations innovate business processes by re-imagining the physical paper-constrained ecosystem. The company is a global leader with Make in India Make for the World credentials. MSB is trusted by more than 5 million users across more than 10,000 enterprises in 188 countries to create a competitive business advantage for them. These include 8 out of the leading 10 Pharma organisations in addition to customers from Automobile Insurance, Banking, Healthcare, Education and Real estate industries. MSB Docs has also been consecutively featured on Gartners eSignature vendor, Gartners Hype-Cycle, and Gartners Market Guide for 5 years. MSB Docs is built in accordance with both the Uniform Electronic Transactions Act (UETA) and the United States Electronic Signatures in Global and National Commerce Act (ESIGN). All data is subject to 256-bit SSL encryption in transit and at rest, with storage at ISO 27001 certified data centres in both the US and the European Union.