| Sherman, who is in India to address a Confederation of Indian Industry's seminar on Innovative Technologies for business excellence in the pharmaceutical industry, said, "The pharma industry is driven by regulations, leading to a stronger focus on compliance, e-common technical document (eCTD) requirements and general considerations." |
| Sharing that over the last few years, the pharma industry in the US and Japan have been moving towards e-submission following the guidance issued by USFDA, Sherman informed that Impact is a select partner for leading content management solution, Documentum, which is already aligned for compliance with the 21 CFR Part 11 Guidance-Electronic Records and Electronic Signatures (electronic records and signatures as valid as paper records and handwritten signatures). |
| In the US, over 65-75 per cent of pharma companies use Documentum. "India currently has the highest number of USFDA approved plants at 75, followed by Italy with 55, while China has 27," said Saroj Kumar Tiwary. |
| The Indian pharma industry, which is currently driven by generics, is slated to emerge as a source of global drug candidates over the next five to seven years and proprietary products will drive long-term growth. |
| Explaining the need for content management solution, as digital information grows at over 200 per cent per annum, Dhananjay Datar, CEO, Impact Systems said, "Indian companies are exploring different solutions and it is only a question of time for them to make a change." |
| Affirming Datar's views that the need for digitalisation and archival of information for future use is becoming a priority for most organisations, S Sivaram, director, National Chemical Laboratory (NCL) said, "We, at NCL are developing a library, Single Molecule Repository as we alone generate over 3,000 molecules in a year. The library will contain the chemical structure of the molecules stored systematically for future use and reference as it will be indexed." |
Top Section
Explore Business Standard