eSHARE: A Non-Intrusive Solution for File Sharing and Content Collaboration in Life Sciences
Modern Software in Regulated Environments
In Life Sciences, computer systems that could affect product quality, safety, or efficacy come under intense regulatory scrutiny. But applying the same level of validation rigor to every system and piece of software unnecessarily increases cost and decreases efficiency. Good Automation Manufacturing Practice (GAMP 5) proposes a risk-based approach: validation effort should be proportionate to a system's criticality, assessed by risk identification, risk impact, and risk probability, and classified as high, medium, or low based on impact to data integrity, patient safety, or product quality.
The eSHARE Secure Collaboration Solution in the Regulated Enterprise
Any system operating cooperatively with a validated environment must itself meet a level of quality and integrity — whether COTS software or SaaS. eSHARE's Secure Collaboration Platform is designed to work cooperatively with high-assurance operating environments by leveraging existing systems in a non-intrusive manner, fully preserving the integrity of the validated environment. eSHARE solutions use only existing customer infrastructure, data rules, and policies, delivering the full value of secure collaboration with zero intrusion or disruption to qualified and validated configurations — robust collaboration without ever moving data from its secure, version-controlled resting place. eSHARE interoperates with whatever storage solution the customer already uses, including Box, Google, AWS, Azure, or internal systems.