Egnyte, the unified content security, compliance, and collaboration solution for multicloud businesses, today announced a new product for emerging life sciences companies to manage regulated documentation.
Egnyte for Life Sciences Quality is an easy-to-use, GxP-compliant product that digitizes the lifecycle of regulated documents, like standard operating procedures (SOPs) and training records.
Egnyte for Life Sciences Quality is the third product in a growing lineup of offerings, following the release of Egnyte for Life Sciences in November 2020 and new review and approval workflows. This enables Quality personnel to streamline review and approval workflows and automate the handling of effective documentation while meeting FDA 21 CFR Part 11 requirements for e-signatures.
‘Quality is a requirement for any Life Sciences company to be successful,’ said Dr Nimita Limaye, Research vice president, life sciences research and development strategy and technology, IDC. ‘High-growth companies, like biotechs, medical device, and diagnostics companies, however, have difficulty scaling paper-based processes, meeting GxP guidelines, and collaborating with their outsourced partners. Cloud-based software solves this: easy-to-use products that automate workflows become a necessity to meet FDA and EMA regulations without sacrificing the speed of innovation.’
‘This product launch is a demonstration of Egnyte’s commitment to serving the needs of life sciences companies that require enhanced collaboration, compliance, and data privacy,’ said Alok Tayi, Ph.D., vice president of life sciences at Egnyte. ‘Companies struggle with managing regulated documents in a compliant manner for three reasons: FDA requirements, training, and the cost of conventional systems. Our Quality solution meets all components of FDA 21 CFR Part 11, including validation, is easy to use to minimize user onboarding, and fits within budgets of start-up companies.’
Egnyte for Life Sciences Quality enables Life Sciences companies to:
- Meet GxP & FDA 21 CFR Part 11: Egnyte’s product digitizes regulated documents and workflows within a compliant software platform reducing administrative burden and improving employee compliance.
- Perform e-Signatures: sign off on documents, like SOPs and clinical trial protocols, in a compliant manner, without needing third-party plugins.
- Manage effective documents: as new versions are approved, Quality teams can easily define version numbers for new drafts, set expiry dates, and ensure only effective copies are available.
- Scale compliance processes quickly: built with best practices gleaned from 17,000 global customers, Egnyte for Life Sciences Quality is easy to use, implement, and validate, as it integrates seamlessly with existing IT infrastructure.
- Support for multiple departments and use cases: designed with the ability to support training, continuity, and site readiness documentation.
Additional products are slated to be launched at Egnyte’s upcoming Life Sciences Virtual Summit on September 14, 2021.
