Luit Infotech Announces A New Release Of LuitBiz DMS For FDA 21 CFR Part 11 Compliance For Pharmaceutical Companies

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23 September 2019
Luit Infotech today announced the latest round of upgrades for LuitBiz DMS, with features for FDA 21 CFR Part 11 Electronic Records Compliance for Pharmaceutical Companies

Luit Infotech, a Bangalore based SaaS Software Company, which develops and licenses business applications software “LuitBiz” that helps businesses manage their entire processes over the Internet, today announced the release of the enhancements in the document management module "LuitBiz DMS" to meet the electronic records management compliance requirements of FDA 21 CFR Part 11 for Pharmaceutical Companies.

LuitBiz DMS is a completely responsive document management system that helps companies of all verticals streamline their document management processes and access / approve documents from anywhere in the world using any device connected to the Internet. LuitBiz DMS is completely customizable to meet the requirements of its customers. It has now been customized to completely meet the compliance requirements of Pharmaceutical companies for FDA 21 CFR Part 11 compliance for electronic records management.

Key features of the new upgrade include enhanced audit trail with timestamp for each and every activity done on the document, access control for the documents based on the rights assigned to them and password protected electronic signature for signing documents with complete timestamp. This is applicable to all records in electronic form that are created, modified, maintained, archived, retrieved or transmitted via the software. The electronic signatures are secured and are linked to the respective electronic records to ensure that they cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means. This is in accordance to the compliance requirements of FDA 21 CFR Part 11 for electronic records management by Pharmaceutical companies.

Our new version of LuitBiz DMS also supports the workflow for the dossier and agreement management for the Regulatory Departments of Pharmaceutical companies. The built-in workflow which can be customized further to meet the regulatory dossier management process of Pharmaceutical companies helps in streamlining the complete dossier creation and submission process along with the related communication pertaining to the dossier.

Additionally, the existing features of LuitBiz DMS like built-in version control, automatic OCR, full text search and advanced search features along with the ability to email documents right from the software and maintain the email records make it an attractive document management solution for Pharmaceutical companies around the globe.

Luit Infotech will continue to upgrade the features of LuitBiz to include modules required by businesses to run their day-to-day affairs, throughout the lifespan of the product. Luit Infotech also provides services to implement LuitBiz and data entry services to help customers get started within the shortest possible time.

Pricing and Availability

LuitBiz DMS pricing is available here. Businesses are encouraged to sign up for a free trial of LuitBiz here

About Luit Infotech
Founded in 2004, Luit Infotech is an India based software company with its registered office in Bangalore. The company is a leading provider of web based SaaS business software. Luit Infotech has developed a SaaS Business Applications Suite "LuitBiz" that has has ERP, CRM (Sales, Marketing, Support, Contact Management & Customer Portal), Human Resource Management (HRM), Employee Self Service (ESS), Document Management (DMS), Business Process Management (BPM) and Corporate Communication modules. Since its inception, Luit Infotech has served a diverse range of customers from enterprise, education, research and manufacturing sectors and built a substantial market presence with many prestigious installations.

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For more information on Luitbiz visit or contact Luit Infotech at+91 80 42061217,


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