Validation Associates and NoteBookMaker, LLC Agree to Consulting Partnership
Validation Associates and NoteBookMaker LLC agree to consulting partnership to bring innovative Part 11-compliant laboratory solutions to life sciences companies.
Raleigh, North Carolina, July 10, 2002 -- Validation Associates Inc., a global provider of regulatory compliance services including 21 CFR Part 11 gap and remediation support, software and computer system validation, process validation, and vendors audits to life sciences companies, today announced that the company has reached a consulting agreement with NoteBookMaker LLC, a technology solution provider of laboratory data management technologies.
The agreement creates a formal partnership between the two companies. In the agreement, Validation Associates will use NoteBookMakers application to demonstrate to their clients how to comply with the FDAs 21 CFR Part 11 requirement for electronic records and electronic signatures for laboratory data management, and to advise on the future development of Part 11-compliance supporting technologies for the NoteBookMaker platform.
Software validation and 21 CFR Part 11 compliance are critical issues for FDA-regulated manufacturers," said Tuan Phan, President of Validation Associates. NoteBookMaker offers a unique and innovative solution for the management of laboratory data as life sciences industry continues to evolve into the realm of digital data management. This partnership allows NoteBookMaker customers to access a compliance service provider who is not only familiar with the application but also demonstrated a history of providing compliance services to life sciences companies. The partnership ensures that the customers implementation of NoteBookMaker is fully compliance with Part 11 requirements."
We look forward to this new partnership with Validation Associates," said Stephen Arpie, NoteBookMakers Founder and Technical Director. Our customers will benefit tremendously from the compliance services provided by Validation Associates for our NoteBookMaker solution, in particular, with the requirements of 21 CFR Part 11."
About Validation Associates
Validation Associates Inc. (VAI) provides regulatory compliance consulting services including 21 CFR Part 11 gap assessments, software and computer system validation, process validation, system and vendors audits, and strategic regulatory management to life sciences companies through its network of highly qualified consultants and industry experts. Validation Associates is headquartered in Raleigh, North Carolina.
On the Net: Validation Associates site: http://www.validationassociates.com
About NoteBookMaker, LLC.
NoteBookMaker, LLC. strives to lead in the creation of the industry's most advanced paperless notebook systems, for use in the scientific, legal, engineering, medical and manufacturing communities. The companys focus is on simple, elegant and legally defensible software.
On the Net: NoteBookMaker site: http://www.notebookmaker.com
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