Electronic document management system for pharmaceutical industry
The documents are not created for auditors and inspectors but for the company to follow a process and procedure for control and traceability. There are numerous documents in pharmaceutical industry which defines which document to follow, what to be done, how it has to be done, who has to do it and who has to review and approve it. This is gives rise to numerous documents which have organized and managed efficiently as per GMP norms.
Good document management is an essential part of the quality assurance system in the GMP requirements. Caliber DMS, is a Document management system for pharmaceutical industry ,which adheres to regulations and standards to ensure GMP compliance. It will help in reducing the overall compliance cost and managing your documentation needs effectively.
Choose the Electronic Document Management system for pharmaceutical industry process
CaliberDMS, the document management system is designed and developed by industry professionals and domain experts who know the challenges of document management, unique to pharma industry. CaliberDMS is implemented and validated in numerous pharmaceutical companies in various countries.
|Document Control Challenges||Automation with Compliance
|Manual and hybrid systems are time consuming and increase redundancy of work and information at various levels and are inefficient. Creation of documents, review, approvals and issue and retrieving of documents take lot of time.||CaliberDMS for document management for pharmaceutical industry automates the document life cycle from initiating, review, approval, controlled distribution of documents. The DMS repository helps in storing and retrieving all version of the documents and make it a apt document management system for pharmaceutical industry.|
|To ensure on maintaining current version of various SOPs, formats, templates and all document types is big challenge in manual process. This requires lot of man days and effort. The cost of working on older version of document is very expensive and has serious business implications.||Every document has version number and when the document is updated the system provides, automatic revision of the number, on review and approval the new version is available to users and the older version is not available to users.|
|In a manual process document preparation and review is using emails results many versions of document and is time consuming and not efficient.||Online document creation and review:Using CaiberDMS Document Management system, documents can be prepared online, it can be reviewed in track change mode with complete audit trail of the changes. The cross functional team review can happen parallelly. This collaborative methodology is efficient and significantly reduces the time to make a document effective.|
|Stake holders need to depend on the excel sheet reporting to get to the details of document types and may not have alert systems on document revisions.The quality process, training process, ERP and documents are different systems and are not integrated to have seamless flow of information in case of deviation or change control.||Caliber DMS reporting, escalation and alert system helps the stake holders to make decisions on documents at various stages
CaliberDMS can be integrated with QAMS and Training management, ERP to make an integrated document management solution for pharmaceutical industry
Features of Caliber DMS a Control Document management system
21CFR Part 11 compliance
- CaliberDMS a document management system for pharmaceutical industry satisfies FDA’s 21 CFR part 11 requirements where all transactions are audit trailed; creation, review, approvals can be configured for electronic signatures.
- The system has password security policies viz password, user name encryption, pass word strengths and expiration and account lockouts.
- To ensure data integrity no transaction can be deleted from the system, unwanted record can be made inactive after approvals.
Manage Different Document Types with different Templates
- Different types of process can be configured in CaliberDMS like SOP, Specifications and Protocol templates and handle all types of electronic documents regardless created outside the system.
- Different templates for each document type with different header footer for a single template can also be configured through the system.
- The system also provides different sequential number for each document type and each department type.
CaliberDMS provides automatic document control for revisions to ensure that only the current version of document is available to users and approval ,previous versions of the document are available in the system to print a obsolete document
Storage and Retrieval
Caliber DMS helps you keep all the documents in a secured network for ease of searching the document for any internal needs or audits.
Caliber Document Management System is built to track documents by status of the document, status of print, status of the reprint, etc.
- CaliberDMS enables electronic documents as documents can be signed and approved by digital signature.
- Digital signature includes the person’s name, date and time stamp.
- The electronic signature can be binded to any document and on any page,this saves a lot time for reviewer and approver, who otherwise need to sign on all pages of the document.
Web-Based Solution and Easy Access
The system being a web application provides a centralized system for easy access, search, and retrieval of electronic documents by all authorized users. Web based system reduces the validation effort as the application is loaded an centralized server not in client systems.
Issuance and Retrieval Tracking
- Caliber DMS enables to have track of each document for issuance and retrieval.
- The system provides the document flow with issuance, retrieval, reference document issuance and document destruction. It has the reports and audit trails for each issuance and retrieval of the document.
- All the printed documents are available under Issuance for logging the details of Issuance.
- In case of multiple plants the system enables Document Transfer from one site to other site.
- The effective documents can be transferred to other sites and after the training, the transferred document can be made effective as per the second plant.
- The second plant users will not be editing the document and it will be available for the print usage.
Online collaborative system for creation, review and approve documents
- Creating and revising documents as a team using our system for document control is easier because Caliber DMS has inbuilt editor which by default has track change mode which allows the user to see other users reviews and inputs.
- The documents can be upload and use for the issuance with issuance code details printed over the document and tracked under Issuance Log. It is also helpful in preparing major form processes or checklists which are unique for each department.
- Creating and revising documents as a team is easier because Caliber’s document management system for pharmaceutical industry provides a collaboration workspace that allows a user to see other people’s input.
- On the same lines, once a user is working on any document, the other users cannot view or alter the document. This helps in avoiding duplication and issues with version control.
Easy Review through Sticky Notes
- Caliber DMS helps the user for easy review of the documents using Sticky notes functionality over any page of the document.
- A reviewer or approver cannot edit the document but the can give the comments through sticky notes ,ensure the over writing of the content.
- Reviewer can view comments given by other users along with different cycles of documents with the remarks and reasons.
Escalations & Alerts
- Majority of the tasks in a company are delayed because they are not escalated on a timely basis. This causes inefficiency and waste of valuable resources for the company.
- Company-wide policies, SOPs and other electronic documents that require inter-departmental collaboration move along a pre-defined workflow, from one department to the next department are saved in the document management system for review. Overdue tasks automatically escalate to a manager.
Cross Functional Team(CFT) Review
Caliber DMS enables the feature called CFT Review or Silent Review. CFT Review is assigning the review of the document to any user or group through the system. CFT Review can be assigned to any number of users or user groups available in the system. The provision of CFT review makes CaliberDMS, a good document management system for pharmaceutical industry.
- Completion of a task can be made dependent on another task to give managers more control and reduce cycle time by prompting users immediately to their next task.
- The role wise review approval workflow and sequentially configured workflow for particular document type will have more control and the dependency between the role level users.
- In order to manage business in a controlled environment, top level management makes important decisions on the basis of several factors. It is imperative to derive parameters that accurately state the condition of the document revision.
- Using filters, reports are also helpful for easy access of multiple documents department-wise and section-wise. The system enables to download the reports into pdf or exporting to excel sheet for the usage.
Integrates with Other Applications
- Seamless integration between different applications for an holistic process. Caliber’s electronic document management system can integrate with other caliber applications such as QAMS and TRIMS applications to accommodate departmental needs.