Dr. Anand Anandkumar serves as the Managing Director and Chairman of the BOD of the India operations of Cellworks. Anandkumar received his MS and PhD in Biomedical & Electrical Engineering from George Washington University, Washington DC. He is a veteran of the Semiconductor Industry with more than 18 years of experience, specializing in Electronic Design Automation (EDA) Software products, IC design and in setting up and running global operations in Emerging markets India and China. Before joining Cellworks, Anandkumar was the founding Managing Director of the India operations of Magma Design Automation, where he was responsible for setting up and driving many aspects of the Operations including RD, Product Engineering, Business Development and links to Government/Academia. The India operation of Magma which Anandkumar founded in 2003 is Magma's largest subsidiary with roughly 25% of the worldwide headcount. Dr. Santanu Datta, Head of Science, BugWorks Before joining Cellworks in 2009 he was the Principal Research Scientist in AstraZeneca India, where he spent more than 2 decades working in Infectious diseases, with a focus on Malaria and MTB. His current interest is in anti-infective drug discovery and recombininat DNA technology and its application in Industrial Biotechnology. He has published widely and has over ten international patents. Dr. Santanu, received his PhD from Calcutta University in Biophysics in 1981 and was trained as a molecular biologist during his post doctoral stint in Baylor College of Medicine USA and Karolinska Institute Sweden.
Dr. Taslimarif Saiyed is Director and COOat the Centre for Cellular and Molecular Platforms (C-CAMP), a Dept of Biotechnology initiative. His initial training has been in neuroscience where he received his PhD from Max-Planck Institute for Brain Research, Germany and followed up by postdoctoral training as a Scientist at University of California San Francisco (UCSF). At the same time, he also took training in management for Biotech and Innovation from UCSF. In his role as Director and COO, Dr. Taslimarif Saiyed manages C-CAMP's strategies, operations, and business worldwide. This includes establishment, management, and promotion of technology facilities, education and training programmes, and innovation accelerator unit. Additionally, he also oversees the Intellectual Property Management Office (IPMO) and Technology Transfer Office (TTO) at C-CAMP.
Dr. Binay Panda has a Ph.D. from University of Oxford, UK and was an American Cancer Society postdoctoral fellow at the Scripps Research Institute, La Jolla, USA. Before returning to India to set up Ganit Labs, he co-founded a molecular diagnostics startup company in the San Francisco bay area with focus on early detection of cancer. Prior to that, he worked at Affymetrix's Santa Clara, California and Tokyo, Japan offices where he was instrumental in building the company's operations in Japan. Binay was a visiting researcher at the University of Tokyo and teaches molecular diagnostics at the University of California, Santa Cruz extension. He has research and commercialization interests in genomics, molecular diagnostics and personalized medicine.
Bharathi Sriram is a professional with experience in preclinical research and development of bio-therapeutics and working in the Indian Biotech industry environment. She is Vice President R & D, at Gangagen Biotechnologies Pvt. Ltd, Bangalore, India which focuses on development of novel therapies for bacterial indications relevant locally and globally. Previously she worked at Dr.Reddy's laboratories, Hyderabad in the areas of Diagnostics and recombinant human protein therapeutics. Her previous associations include AstraZeneca, formerly Astra Research Centre India.
In 1997 the United States Food and Drug Administration (FDA) issued a regulation that provides criteria for acceptance by the FDA of electronic records, electronic signatures and handwritten signatures. With the introduction of this regulation, titled Rule 21 CFR Part 11, electronic records can be considered, under certain circumstances, as equivalent to paper records and handwritten signatures.
The rule applies to all industry segments regulated by the FDA including Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP) and has an impact on all FDA regulated industries that use computers for regulated activities.
Requirements of Part 11 include:
21 CFR Part 11 has high visibility and is the subject of discussion not only in the United States but also in many other countries for two main reasons:
1. Many pharmaceutical companies located outside the US export drugs to the US market, and as such they have to follow US regulations. The FDA can inspect these companies according to US regulations. In case of non-compliance, the company is not allowed to export pertinent drugs to the United States, which can have a tremendous business impact.2. Other countries have similar issues with electronic submissions and may use the US rule as a guideline for their local regulation. For example, in Japan a regulation on electronic signatures and records was released in April 2005.
Currently the use of electronic records as well as their submission is voluntary. Despite this voluntary character, pharmaceutical companies are already trying to implement the rule as quickly as possible because of three primary reasons:
1. In many situations using computers is a necessity, for example in analytical laboratories where instrument data systems are used for automated data acquisition and evaluation. In this case the laboratories must comply with Part 11.2. There may come a time when the FDA will no longer accept paper records 3. Electronic records have some significant advantages vs. paper records: tangibly lower space requirements and easier retrieval are just two of those advantages.
Implementing systems within the framework of Part 11 will have a significant impact on the instrumentation, the work processes and on the people in operations such as quality control laboratories and manufacturing operations.
The use of electronic records is expected to be more cost effective for both the industry and the FDA. The approval process is expected to be shorter and access to documentation will be faster and more efficient. Fully electronic data acquisition, evaluation, management and archiving promises to deliver major improvements in laboratory workflow.
What are the industry best practices for achieving this? What are the recommended systems?
First of all it is important to understand that no application can ensure regulatory compliance by itself. Compliance with the ruling requires that applications be run under the definition of a closed system. This is an environment where there is controlled access to the PCs upon which the applications are running and where there are procedures in place that define the activities of the users on those PCs. The PCs need to have controls and operating systems loaded that restrict access and identify the users of the systems.
Electronic Laboratory Notebooks are an example of systems that, when implemented in the proper environment, will help laboratories achieve 21 CFR Part 11 compliance while introducing significant benefits to laboratories across the spectrum from R&D through to QA/QC and manufacturing.
In R&D, an application like E-Notebook from PerkinElmer Informatics makes it possible for scientists to record and manage diverse types of data in an electronic format. The organization of the data can be customized to match scientists workflow, and maintaining the data in an electronic format provides many advantages over a paper format. For example, E-Notebook can be integrated with other computer systems, users can conduct searches over the E-Notebook database, and they can easily share data amongst multiple people.
In the QA/QC and manufacturing sectors, where organizations need to ensure that sample testing follows rigorous and repeatable processes, an ELN can provide a controlled and structured platform ensuring all standard operating procedure (SOP) requirements for testing are met every time. Nexxis ELN from PerkinElmer Informatics is an example of an ELN that can be integrated with other informatics systems to ensure and document that SOP requirements (instrument calibration, use of appropriate materials, analyst training, etc) are rigorously followed each and every time.
Laboratories that introduce Electronic Laboratory Notebooks can realize immediate reductions in costs by simply moving from paper to electronic documents.
For Indian laboratories, the decision to implement informatics applications that support compliance with 21 CFR Part 11 delivers multiple benefits. They are protecting their access to regulated markets in the US and other countries while implementing electronic processes and procedures that can reduce costs while enhancing their ability to deliver world class results.
David Gill is Managing Director of the St John's Innovation Centre in Cambridge. From 2005 to 2008, he served as a director of ETCapital Limited, a venture firm specialising in early-stage, technology-based investments. He previously set up and ran the Innovation & Technology Unit at HSBC Bank in London, during which time he was oversaw HSBC's funding of two professorial chairs of innovation and the creation of a national network of technology banking managers. Educated at Cambridge, he qualified as a barrister before working in corporate finance for US and UK banks. He was a Sloan Fellow at the Stanford Graduate School of Business in California (2005). David is the co-author of several country-based reviews of the commercialisation of innovation and a recent analysis of the impact of incubation on growth firms. He is an Official Visitor at the University of Cambridge Institute for Manufacturing, a non-executive director of UK Business Incubation Ltd and a member of the UK Government Department for Business Access to Finance Expert Group. He is also Treasurer of Westcott House theological college. He was made Master of the University by Brunel University in June 2002; and in March 2011 he won the UKBI award for Outstanding Contribution to Business Incubation.
