Key challenges with Manual Document Management in Pharma, CDMO, Biotech and CRO Industries
Time consuming:
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.
Chances of losing document:
In manual SOP Management/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.
Version tracking:
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.
Training challenges:
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
No Auto alerts/reminders:
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.
Inter-department Analysis:
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.
Loss of Documents:
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 Retrieval:
Document issuance, print tracking, Retrieval of the issued document are major challenges in manual document management system
They key features of AmpleLogic DMS are as below:
A. Document Template Management:
A user of AmpleLogic DMS can develop templates for any document kinds. The process of creating a template is one-time, and then you can use the saved template to produce new papers. It is up to the user to decide whether to develop a new template or make changes to an existing one before submitting it for approval. The workflow can be set following the SOP.
B. Document Creation
End users can upload a previously created document, which is automatically converted to PDF, and use AmpleLogic Electronic Document Management Software to create a new document from it. The process flow differs depending on the type of document it is dealing with.
Search Feature:
- AmpleLogic Digital Document Management System (DMS) acts as a central store for all kinds of documents. Dynamic and advanced search functions are built into the system, allowing users to conduct custom searches based on their preferences.
Document Numbering Format:
- The numbering format can be specified on a different screen in the DMS. With the combination of SOP and Type, the system provides a unique numerical format.
Page Controls:
- The Pharma DMS Software System lets the user configure the controls that will appear on the header, footer, and final page. When the format is used, the header and footer are automatically printed. The controls can be the same on all pages or they can be different for each one of them. The creation of the numbering format and controls is a one-time task. Duplication will be restricted as a result of a validation fault in the system.
Levels in Document Types:
- AmpleLogic’s EDMS software features a unique function that categorizes documents into four levels based on their importance. Each document type can have its procedure and set of approvals. It is dependent on the document type’s complexity when it comes to the workflow and approval.
The following are the several levels of the standard documents:
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 Annexure’s
The end-user can add Annexure’s, Formats, or both if the SOP includes accompanying child papers while producing a new SOP or revising an existing SOP. This simplifies the process as compared to manual procedures where this is not practicable. Creating an SOP with child forms can be confusing if you are not using the AmpleLogic Digital Document Management System, which requires users to finish the child activity first (Annexure’s and Formats) before moving on to the parent document.
C. Document Review:
The AmpleLogic Online Document Management System features an inherent function that allows the reviewer to add comments about the document while it is open online. You can do this by dragging and dropping the application’s tools.
The comment summary area in the software allows you to keep track of all of the comments.
D. Document Requisition and Print Control
Document Tracking Software from AmpleLogic gives us access to a separate screen where we can specify how many copies we want to be printed, as well as which pages we want to be printed for what purpose. As a result, each document type print demand has its flow. If a reprint is required, then a reprint request should be submitted by authorized personnel only after seeking and approval.
E. PDF Conversion
The PDF Version feature in AmpleLogic Digital Document Control Software / EDMS Software allows users to create a PDF version of file formats like Word document, Excel, CSV, and Txt with only a single click. It preserves the version history of both the source document and the converted PDF version.
F. Watermark Printing
The training copy, controlled copy, and uncontrolled copy options in the AmpleLogic EDMS System allow you to print different watermarks depending on the type of request.
G. Document Issuance
AmpleLogic Electronic Document Management Software is defined with a specific issuance flow where the issuance of BMR, BPR copies, and other documents can be tracked along with the number of copies issued, the number of prints taken, and the number of reprints requested. Document issuance and retrieval is a major challenge in manual document management.
For the user to directly reprint the papers, he must first ask for reprinting with a specified cause for doing so and then follow an approval process that has been set up following the requirement.
Many organizations struggle with document retrieval. The predefined retrieval mechanism in the AmpleLogic EDMS system enables for tracking of documents being retrieved and returned to the system.
H. Automatic Version Control:
The Pharmaceutical DMS System keeps track of the most recent version of every document that is created and makes it easy to access that version. The version number is updated in accordance with the SOP each time the document is modified. It is not possible to access an older version of a document after it has been updated; only the most recent version is available.
I. Document Comparison
AmpleLogic Document Control Software provides a unique function that enables the user to compare two papers and determine which modifications were made between the two documents. This feature enables the user to keep track of document changes.
J. Revision History
Automatic version control prevents users from relying on outdated or unapproved versions of files. You may see the history of revisions, including the reasons for each modification in the comments history, when and who approved it, and the approver’s signature in the audit trail, all of which include time and date stamps.
H. Child Documents
A distinct flow and approval are available for child documents when they are submitted along with the parent document. This reduces the risk of document loss and complexity when the process is done manually.
I. Document Collaboration
Document creation includes an option to transmit for parallel review if collaboration is necessary while using the system.
J. Content Search
The Document Control Software System has a capability and feature for content search, which enables the end-user to search within the repository of documents using key phrases.
K. Integration
Most businesses use separate systems to handle CAPA, audit training, and other related tasks. Because of this, the entire Document Preparation process is slowed to a crawl.
AmpleLogic DMS can be combined with other systems, such as Quality Management Systems (QMS), Learning Management Systems (LMS), and so on, to make document preparation and handling simpler.
Many companies are on the lookout for an all-in-one Document Management System.
L. Integration with Change Control
To update an SOP the system requires the user to initiate a change control and give the necessary information to initiate the document’s update. This can be problematic in manual documentation because it is easy to overlook important information.
It is possible to auto-populate the details in the AmpleLogic Document Management System with Change Control, and the system will not let users go any further without those details.
M. Dashboard:
The dashboard of the AmpleLogic Document Management Software shows all of the tasks that the end-user has left to complete. As soon as the end-user logs in, he can see the dashboards. The end-user will benefit greatly from not missing any pending tasks as a result of this.
N. Reports:
With the help of the AmpleLogic Pharma DMS System, the management can use a variety of reports and visual representations in various review sessions. Different types of reports include:
- Traceability Report
- Documents for revision report
- Summary Report
O. Data Archival
We can define an archiving mechanism in AmpleLogic Electronic Document Management System so that data can be archived at a predetermined frequency of time based on the company’s SOP. Only roles specified by the organization have access to archived data.
P. Regulatory Compliance
AmpleLogic SOP Management Software complies with all applicable requirements, including 21 CFR Part 11, EU Annex 11, WHO, MHRA, and ISO. By default, features such as an audit trail, electronic signature, form report, and second-level authentication are provided.
Again, access to archived data is role-based, so not everyone will have full access to it.
Q. Role-based Access:
The user’s role in the organization determines access to the document and archives. Even access to different screens is restricted based on the user’s position.
Next Release:
Amplelogic EDMS System will be powered by ML and AI
- It will auto-detect CFT requirements and route tasks using machine learning and artificial intelligence algorithms
- There will be automatic reviews triggered for the impacted document
Benefits of Electronic Document Management and Issuance Software in cGMP Environments
- The customer’s SOP can be used to design the document process
- AmpleLogic’s Pharmaceutical Document Management Software includes automated email triggers, reminders, and escalation
- It lowers the difficulty associated with conducting document-related tasks manually and ensures data integrity.
- It makes easier for co-workers who are involved in document preparation to work together.
- Because all documents are stored digitally in a repository, users can access them at any time by logging into the system with their unique login ID and Password
- All documents are saved on a secure server with defined backup and recovery procedures, so there is no risk or worry of losing data by using SOP Document Management Software
- Using an automated Digital Document Management System decreases the risk of non-conformance by automating the entire process and eliminating manual errors
- It is easier to spot missing documents when documents are issued under strict control and total prints are reconciled
- As document retrieval is difficult in a manual process, it becomes simple with an automated DMS
- The Document Issuance staff does not have to be available 24/7 because the system is automated
- Since documents prepared manually are saved in a physical storage, a lot of space is used up and there is always the risk of physical damage and data loss. If a DMS is in place, all data is stored on a secure server with recovery and backup capabilities
- Automated DMS System have real-time tracking, email notifications, reminders, and escalations so that end users never miss TCD deadlines or TCDs. This eliminates the need for manual processes
- There is no mechanism in place to track the most recent document, and versions are not updated effectively in the manual process. When using an automated DMS, the system automatically creates version numbers whenever a document is updated
- Teams can have much easier and improved access to one another with this Pharmaceutical Document Control Software
AmpleLogic Electronic Document Management Software complies with TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH Electronic Record Standards.
Our On-Premise and Cloud-Based Document Management Software can also be used in the following fields:
- Biologics
- Medical Devices
- Contract Development and Manufacturing Organization (CDMO)
- Chemical Industry
- Contract Manufacturing
- Generics
- General Manufacturing
- Contract Research Organization (CRO)
- Food & Beverages
To learn more about how AmpleLogic Pharma DMS Software or an Electronic Document Management System can benefit your company, please get in touch with us.
