Softsign Document Mangement System
Sruta’s SOFTSIGN, paperless document management system, enables you to endure the effortless management of all the GxP document lifecycle all with “The Elevens” (21 CFR Part 11 and EU Annex 11) compliance.
Diverse exercises like document creation, review, approval, revision issuance, retrieval, archiving, are version control, are part of the SOFTSIGN Document Management System. Altogether with presented controls, e-signature, audit trails, and role-based access controls are additional features that can achieve compliance as needed in Computer System Validation
Softsign also helps to organize the entire company’s documents with complete control and traceability. It also confirms the usability of the latest published versioning of the document and eliminates the chance of practicing old documentation. Also, minor and major versioning control enable you to keep track of the editability of distributed documents.
Besides, document issue and retrieval is the pain point that we understand and support you in taking care of. For an instance, the system ensures the issuance and on-time retrieval of the documents. Also, a reprint of the same is easily traceable by the date and time on which it has been retrieved.
All in all, Sruta’s SOFTSIGN is all that you need to actively manage GxP documentation.
CHALLENGES WITH TRADITIONAL DOCUMENT MANAGEMENT PRACTICE
Non-compliant Storage and Archiving – Unavailability of the document when needed and difficulty in retrieving data for new indications
Missing Revision Dates – Forgetting to revise documents
Damage to Documents – Losing data back off natural calamities or fire accidents
Financial & Environmental Damage – A time-intensive & expensive paper-based process
BENEFITS OF SOFTSIGN - ELECTRONIC DMS
Efficiency through automation – SOFTSIGN lessens document cycle time and streamlines document management by automated routing, notification and follow-up, escalation, and approval of a pharmaceutical’s documents.
Robust tracking and history – Identifies bottlenecks by indicating when a document was sent and to whom. Also, it presents the document’s history mentioning details of approver and time of approval.
Web-based Platform – Providing easy access to documents from different locations and time zones based on the extent of people’s roles in any document-based process.
Fostering Efficiency – Electronic approval enables the capability to review and approve documents electronically, resulting in an accelerated approval process.
The Elevens – Electronic signature manifestation appended to each document as required by 21 CFR Part 11.
Defeat Compliance Burden – Risk-based validation of Configurable system, category-4, proffering to minimize the time, trouble, and cost associated with validation.
FEATURES OF SOFTSIGN
Improved User Experience
A smart user interface and web-based platform enable seamless accessibility for the users.
Fit-for-Purpose
Configurable workflow that reduces implementation time and enables you to use the system just the day after it is installed.
Compliance
Ensure compliance with The Elevens and GAMP5. A system that is developed by pharmaceutical experts for the pharmaceutical industry.
Automated Versioning
An automated minor and major versioning for revised documents specifically to avoid duplication of documents.
Metadata
Configurable forms and screens to capture necessary metadata and enable users to quicken the implementation process.
Lifecycle
Creation to printing, retrieval, and any other GxP document process operation in one place.
E-signature
Electronic signature inclusive of date and time helps you keep track of edits, approval, intended action, and many other functions available for documentations.
Reminders and escalations
Never miss the revision dates as real-time tracking, email notifications, reminders and escalations allow you to be on track with revisions and versioning.
Security
Challenges of remote working are resolved with controlled access that restricts individuals from copying, recording, or printing the shared documentation.