Unlock eSignature Licitness for Quality Assurance in India with airSlate SignNow

How to eSign a document: e-signature licitness for Quality Assurance in India

[Music] hello I'm Wally Baker from openex and today I'm going to talk to you about computerized system validation also known as CSV so let's get started the healthcare and life science Industry is entering a digital age where Innovations happens at a very fast pace with so many opportunities in front of you don't let inefficient computerized system validation activities drag you down Main retain or even gain momentum with application life cycle management processes or Alm where digital processes helps you stay compliant so what is computerized system validation in healthcare and Life Sciences CSV is a systematic process that involves a number of critical and important activities in a product life cycle verifying that the final product quality complies ing to regulatory requirements and will produce information and data that meets those defined requirements in this business you must maintain meticulous records for development and Manufacturing to QA and across supply chain processes you may need to comply with regulations such as Hippa US Food and Drug Administration title 21 cfr1 part 820 part 210 and 211 cgmp eurolex volume 4 and next 11 and even others failing to to comply may lead to Hefty penalties a damaged reputation but more importantly lost lives GM or gam five also known as good automated manufacturing practice the guideline adopted worldwide for CSV helps you to stay compliant it defines four life cycle phases for computerized systems conception project operation and retirement which matches well with Opex application life cycle management solution approach of continuous quality throughout the life cycle openex has these solutions to help you solve and securely scale your compliance requirements for regulated Industries our Solutions are available on your choice of platform either through value Edge Alm quality Center and Alm octane suiting your preferred method of operation which can in turn be combined with our electronic signature solution also known as EIG for Alm to accelerate and Empower your specific Regulatory Compliance needs our Solutions provide you with requirement and risk-based life cycle approach complete traceability and audit logs solid processes aligned to regulatory requirements data transparency and real-time insights integrated records management from all sources and collaborative platforms with flexible deployment options solve your Regulatory Compliance challenges with open taex move fast and let your distributed Workforce collaborate productively and embrace a new digitized way to achieve high efficiency in computerized system validation