Electronic Document Management and Tracking Software for Life Sciences
Adopting Automation, is a very important step for every Pharmaceutical, Biotechnology, Lifesciences and Medical devices organization to meet the pace, and compete for the race in a an extremely dynamic industry . Enormous growth in document content and procedures makes the manual document handling task critical. Document Issuance will be done against manual request. AmpleLogic Electronic Document Management System (eDMS) ensures the best experience to handle all documents and helps organizations manage them on the go from anywhere.
Managing documents from several sources becomes challenging and time-consuming. AmpleLogic eDMS a power-packed electronic document management system exclusively designed for Pharmaceutical and Biotech companies, developed and implemented exclusively to meet the cGMP needs of Pharma domain with 21CFR Part 11 compliance, EU Annex 11 compliance can easily eliminate all the challenges faced by different companies
AmpleLogic eDMS paperless document management system enables you to experience the effortless handling of all the documents and information.
Various activities like document creation, review, approval, editing, document comparison, version control, parallel reviews are part of AmpleLogic Document Management System.
AmpleLogic DMS helps to streamline the entire organization’s documents with full control and traceability. It ensures that the latest published document is used and eliminates the risk of using obsolete documentation.
AmpleLogic Electronic Document Management and Issuance Software has been developed on the highly configurable LOW CODE APPLICATION DEVELOPMENT PLATFORM. EDMS can be accessed from any devices.
Challenges with manual SOP Management Process in Pharmaceutical & Biotech Industries
- One of the major challenges in the Document management System is the process of manual document preparation. It is a time-intensive process because collaboration between teams may not be streamlined and can lead to extension in time frames.
- In manual document management process, there is always a danger of losing the document as the entire procedure is manual. The user can misplace the document. As a result, it might not be available when it is required.
- A major and gruesome challenge in the manual document management process which leads to lots of regulatory observations for many companies is to maintain a track of versions. There is always a danger of unavailability of the latest version of the document because the entire process of document updating is manual and there is no track of activities.
- As the manual document management procedure is not integrated with the Learning Management System there is always a challenge in training the people for the updated documents. AmpleLogic integrated Document Management System is linked with the Learning Management System and whenever the Document is updated there is training need generated in Learning Management System automatically.
- In manual document management system, there is always a possibility to miss the next revision date as there is no provision to remind the user about the next revision date. AmpleLogic eDMS has automatic reminders, notification and escalation mechanism which intimates the users so that they will never miss the next revision date.
- While preparing or updating a document parallel collaboration between departments like production, engineering, quality assurance might be required which is not possible in manual document management.
- As all the documents are stored in a physical storage there is always a danger of damage of documents due to natural calamities, fire accidents or any other specific reason.
- Document issuance, print tracking, Retrieval of the issued document are major challenges in manual document management system
Pharmaceutical Document Management and Tracking Software Features
Document Template Management:
AmpleLogic DMS allows the user to create a template for all the document types. Template creation is a one-time activity, the created and saved template can be used to create the documents. The user can either create a new template or update the existing template, if there are any changes, and get it approved. The workflow can be defined according the SOP.
AmpleLogic Electronic Document Management Software will allow the end user to create the document by uploading the already created document which is by default converted to PDF. There is a separate flow defined for each document type.
- Search Feature: AmpleLogic DMS serves as a repository for the all the types of documents created. The solution has a dynamic and advanced search feature which will allow the users to search using different search criteria.
- Document Numbering Format: AmpleLogic DMS has a separate screen to define the numbering format. The system generates unique numbering format according to the combination of SOP and SOP Type.
- Page Controls: The system also enables the user to define the controls to be printed on the header, footer and the last page. These are directly printed on the header and footer when the user is using the format. The controls can be common for all pages or can differ. Creation of Numbering format and controls is also a one-time activity. The system will restrict duplication by validation error.
- Levels in Document Types: AmpleLogic DMS has a special feature which has divided the types of documents in to four levels. Separate workflow and approvals can be defined to each document type. The workflow and approval depends on the complexity of the document type.
The Standard Document types level wise are as follow
Level 1 : Apex Documents (Site Masters, Validation Master Plans, QM, QP, APQR)
Level 2: SOP,Protocols, Specifications and STP
Level 3: BMR, BPR
Level 4: Formats and Annexures
While preparing a new SOP or updating an existing SOP, the end user can add Annexures, Formats or both if the SOP has the child documents to be accompanied. This reduces the complexity when compared to manual procedure where it is not possible to do so.
The AmpleLogic Digital Document Management System mandates the user to complete the child activity first (Annexures and Formats) and then complete the parent document, this feature eliminates confusion while creating a SOP accompanied by child forms.
AmpleLogic Online Document Management System has an inbuilt feature where the reviewer can review the document online by entering appropriate comments in the document. This can be done by dragging and dropping the tools given in the application.
All the comments can be tracked in the comment summary section
Document Requisition and Print Control:
AmpleLogic DMS has a separate screen where we can request for print along with number of the copies, and specific page request with purpose. So, there is a separate flow for each document type print requisition. Only authorized personnel can take the print after requesting and approval, if a reprint is required, then request for reprint should be made.
AmpleLogic eDMS has a provision to print the watermarks based on the type of request like training copy, Controlled copy, Uncontrolled copy etc.
Document issuance and retrieval is one of the major challenges in manual document management, AmpleLogic Document Management Software is defined with a specific issuance flow where issuance of BMR, BPR copies, and other documents can be tracked along with the number of copies issued, number of prints taken, and number of reprints requested.
User cannot directly reprint the documents, if he wants a reprint, he should request for reprint with defined reason for reprint request which has an approval flow defined according to requirement.
Retrieval of documents,being the major challenge for many companies AmpleLogic eDMS software also has predefined retrieval mechanism in the system which allows to track retrieval of the documents back into system.
Automatic Version Control:
System automatically updates the version of each document created and maintains the latest version for access. Whenever the document is updated the version is incremented according to the SOP. When a new version of a document becomes effective, access to the previous version is not allowed and only the current version will be available.
AmpleLogic DMS has a unique feature which helps the user to make comparison between the two documents and identify what are the changes which were made in the current document from the previous document. This feature helps the user to track the changes in the document.
Automatic version control ensures that users will not make the mistake of using obsolete or unapproved documents. It provides revision history, including reasons for every change in comments history, when it was approved, who approved it, and the approver’s signature in the audit trail with date and time stamp.
While creating a document, the system has a provision to send for parallel review if there is a collaboration required.
Child Documents :
There is a separate flow and approval for child documents if they are accompanied with the parent document, eliminating the complexity and loss of document while doing it manually.
The system has a feature and feasibility for content search which helps the end user to search from the repository of the documents with the key words
Most of the companies have different systems for managing the CAPA, Audit Training and other processes which are not connected. This creates a huge confusion and delays the entire procedure of Document Preparation.
AmpleLogic DMS can be integrated with Quality Management System, Learning Management System and other processes to reduce the complexity of handling and preparation of documents.
Many companies look for an integrated Document Management System.
Integration with Change Control:
To update an SOP the system mandates the user to initiate a Change control and provide the details to initiate the update of the document. In manual documentation, this can be confusing and there is always a possibility to miss crucial details.
AmpleLogic Audit ready Document Management System is integrated with Change Control, where the details can be auto populated, and the system will not allow users to go further ahead without Change control details.
AmpleLogic Document Management System has a dashboard which shows the end user all the pending tasks from his end. The end user can see the dash boards as soon as he logs in. This will help the end user not to miss any pending task
AmpleLogic DMS generates several reports and graphical representations that will help the management in different review meetings. Different types of reports include
- Traceability Report
- Documents for revision report
- Summary Report
Data Archival :
In AmpleLogic Electronic Document Management system we can define an archiving mechanism where archiving of the data can be done on specified frequency of time depending upon the SOP of the company. Access to the archived data can be given to specific roles only defined according to the organization.
Regulatory Compliance :
AmpleLogic eDMS is compliant with 21 CFR Part 11, EU Annex 11, WHO, MHRA and ISO regulations. Features like audit trail, e-signature, form report, second level authentication, are by default available.
Access to archived data is again role defined, not all people will have access to archived data.
Role based access :
Access to the document and archives is defined according to the user’s role in the organization. Even access to different screens is dependent on the user’s role.
- Document workflow can be defined according to the SOP of the customer.
- Automated email triggers, reminders and escalation are a part of AmpleLogic’s default DMS.
Benefits of Electronic Document Management and Issuance Software in cGMP Environments
- Reduces the complexity involved in performing the document related activities manually and Data Integrity will be maintained
- Enhanced collaboration between peers who are involved in the document preparation.
- As all the documents are digitally available in a repository, system enables users to access the documents anytime by logging in to the system with their specific login ID and Password.
- No data is lost as all the documents are stored in a secure server with defined backup and recovery.
- Having automated Document Management System reduces the risk of non-conformance as the entire process is automated and manual errors are eliminated.
- Controlled issuance of the documents and reconciliation of total Prints helps in observations related to missing documents
- As retrieval of documents is a big challenge in manual process the retrieval becomes easy in an automated DMS.
- As the system is automated, Document Issuance team is not required 24×7.
- As all the documents which are created manually are stored in a physical storage there is a huge space occupied and there is always a danger of physical damage and loss of data, if there is a DMS in place the entire data is stored in a secure server with recovery and backup.
- End users always miss the deadlines or TCD as there is no proper mechanism for reminders and escalations in manual processes, this is eliminated because the automated DMS system features real time tracking, email notifications, reminders and escalations.
- There is no proper mechanism to track the latest document and versions are not updated properly as the entire process is manual. With automated DMS the system generates the version numbers automatically whenever the document is updated.
- Easy and improved communication between the teams.
- Track of printing, who has taken the print, printed document has the e-signature date and time of the print
AmpleLogic Electronic Document Management Software complies with Electronic Record Standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA and MoH
Next Release :
Amplelogic EDMS is going to be ML and AI driven
- with the Machine learning and Artificial Intelligence Algorithms to auto detect the CFT Requirements and Route the Tasks
- Impacted document will be auto reviews triggered