Challenges like lack of proper document escalation flow, improper document revision and getting document signatures made AmpleLogic to design and develop Electronic document management system.
In Pharmaceutical companies each and every activity within a GMP (Good Manufacturing Practice) regulated environment such as US FDA, MHRA, 21 CFR part 11 and EU Annexure 11 is based upon controlled documents and revision control. Therefore Document Control, Management and Issuance is core to the functioning of the Life Sciences companies and exhibiting Compliance and Quality.
AmpleLogic improves document access, achieve assured regulatory compliance and resolve all the major challenges related to Document Management.
Imagine there is a fire accident due to manmade or natural disaster and storage where all the important documents are stored caught fire, all the documents are burnt into ashes this may lead to loss of important Documents.
The company’s massive scope of operations and its geographical spread meant that large volumes of data of varied genres are being created at dispersed locations. It is essential that the content is centralized and organized in a way that optimizes its usefulness to multiple users across the organization. Document data transparency is the key factor.
Whenever an SOP (Standard operating procedure) is updated or any changes are made, this has to be done with raise in change request, each and every process is done manually and there is no track of versioning. SOP tracking and Document Versioning is being critical.
There is an example of unplanned audit, a new machine is installed in the plant with no information about the SOP of the instrument, this reduces the confidence of the auditor on the organization.
There is an important and critical update (Document Review and Updations) in the existing document by documenter without being aware of the absence of reviewer and approver for the document, this delays the entire process which incurs in huge cost for operation and maintaining.
Few common document handling Challenges:
- Lot of time is lost in document search. Incorrectly handled or loss of paperwork causes damage.
- Filing of documents requires space at the individual work places as well as in the registry. Up to 30 % of document access are unsuccessful, because the documents are incorrectly filed, lost or being processed.
- On average, every document gets copied two to three times.
- The actual amount of time it takes from processing a document until the final filing.
- Change control and version control of office documents is very difficult.
Features of AmpleLogic DMS:
- Word Based Editor-where you can edit the document on the go and re upload at one click of a button.
- Word is directly converted to pdf with no alterations/editing on uploaded document.
- Robust search feature for all records with flexible and transparent retrieval at any point of time.
- Separate workflow for template, annexure and SOP’s can be defined for each document type.
- Font style, size and numbering format selection allows to fetch controls print as specified.
- Document comments can be given by the reviewer on allowing specific controls dragging for document comments.
- Document comparison within various versions of any two revisions to identify applicable changes on the document.
- Auto printing of selected controls with exact positioning which helps to define and configure document format according to requirement.
- Auto supersede the old version, once new version is approved. Revision control and smooth document archival can be achieved.
- Graphical reports, Summary, Traceability, Audit trail and Documents for Revisions.
Reduced storage Space:
Physical space is required to store the organization documents, this can be eliminated by useing an electronic document management system.
AmpleLogic DMS allows to store documents like SOP’s, Protocol’s, Batch Master Copies, Templates and Annexures.
Simplified Document Creation:
There are various different document types, such as SOP’s, Protocol’s, Batch Master Copies, Templates and Annexures and each type of document must be treated differently. These document types may consist of separate approvers, managers and workflows. The automated document control system addresses each document by type and assigns the appropriate workflow to it. Each workflow will be treated differently and will be assigned for its own unique routing.
Print Management is different for Training copy, Issuance copy and Uncontrolled copy. Print access can be defined for each and every individual document based on the role access.
Whenever the print got stopped due to some external issue, we can have an option of Additional page printing to start printing from where it has been terminated.
Every document has its own unique number defined by the system according to standard Document SOP (Standard Operating Procedures) mentioned numbering format, which should be pre-approved. We can maintain separate numbering formats for SOP’s, Batch Master Copies, and Annexures.This helps to keep track of each document.
Integration with Learning Management System:
When there are changes made to any document, employees need to be informed of new procedures and specifications and trained on any new revisions that are released. A document control system integrated with a Learning Management system easily helps to define who needs training on each document.
It also automatically updates training records for each employee, allows for self-training, and automatically updates each employee status upon training completion.
Makes Audit Easy:
Pharma manufacturing companies are subject to compliance mandates and audits, record keeping is a huge responsibility. When your documents are tracked and accessible 24/7, aggregate information is easier to compile and due dates are managed, this makes audits easy.
Standard template can be created for each and every individual SOP, or process which can stored and used for further reference.
Whenever there is an update in the previous created document, we sometimes need to compare both the versions in this case document comparison feature is useful.