Houston, TX, and Nottingham, UK - 31 May, 2004
ClinPhone, the world’s leading provider of Clinical Technology Services today announced that it has chosen CoSign, ARX’s ultimate electronic signature solution as its electronic signature solution to meet with stringent FDA 21 CFR part 11 regulations. CoSign will help ClinPhone ensure accountability and data integrity of sensitive internal documents. ARX’s electronic signature solution allows ClinPhone to easily migrate to a paperless office environment, significantly reducing the costs of paper, printing handling, faxing and mailing.
Pharmaceutical industries are governed by a number of regulations, primarily the FDA's 21 CFR part 11 which has specific requirements for electronic records, electronic signatures and digital signatures. These requirements mandate user authentication and accountability, data integrity as well as stating the time and reason for each signature. CoSign’s unique capabilities which include embedding electronic and electronic signatures within the document and password-based user authentication enable ClinPhone to comply with both the electronic and electronic signature FDA 21 CFR Part 11 stringent regulations.
CoSign is ARX’s non-forgeable and simple-to-use electronic signature solution that eliminates the need of handwritten signatures. CoSign delivers an innovative way to digitally sign documents and transactions within numerous applications anywhere anytime.
Currently, ClinPhone generates documents such as Requirement Specifications, Technical Specifications, Validation Reports and Standard Operating Procedures (SOP) that need to be signed by several authors, reviewers and approvers and which involves heavy printing, handling, faxing and archiving. Manually signing one document can take between several hours to several days due to ClinPhone’s global presence. CoSign enables ClinPhone to migrate to an electronic document system thereby saving paper expenses and significantly expediting ClinPhone’s procedures, while allowing ClinPhone to comply with the FDA’s regulations that require electronic-signatures for electronic documents
CoSign’s unique multiple signature capability addresses ClinPhone’s multiple approval requirements and allows for one document with multiple signatures. This feature eliminates the need for a long audit trail with separate forms documenting each individual’s signature.
In addition, the electronic signature and the graphical image of the handwritten signature that CoSign inserts in the Word document cannot be duplicated, altered or tampered with, ensuring a reliable and unique electronic signature solution.
ClinPhone undergoes continuous auditing by external organizations such as the FDA, whereby all the electronic signatures in the document must be validated. CoSign signatures are instantly verified by major applications anywhere anytime guaranteeing that the message content has not been altered.
CoSign has been successfully integrated with ClinPhone’s existing User Management System, offering a quick and easy deployment phase exclusive of any additional overhead costs.
“ClinPhone has evaluated a number of electronic and electronic signature products and CoSign provides an elegant solution for both our business and regulatory requirements,” said Dr Jonathan Engler, Joint Managing Director, ClinPhone Group Limited. “Our product selection process was assisted by the impressive technical knowledge, understanding and helpfulness of ARX's staff'.”
“ARX is pleased to provide ClinPhone with a trustworthy electronic signature solution that allows compliance with 21 CFR Part 11 signature requirements,” said Motty Alon, VP of Marketing, ARX. “The deployment of CoSign at ClinPhone continues our positioning as a leading electronic signature solution provider for the Life Sciences industry. ARX’s CoSign offers a cost-effective electronic signature solution that simplifies the automation of the clinical trial process.”
