A vast volume of highly regulated data is produced by a drug-producing company on a daily basis. Various documents, such as Standard Operating Procedures (SOPs), specifications, protocols, documents, forms, policies and log books must be maintained in a precise and timely manner ensuring their availability at all times.
Managing all of those documents using folders, spreadsheets and paper files becomes more complex as the business develops. This is the point where Document Management System (DMS) is needed to ensure that everything is done according to regulations concerning pharmaceutical products.
The DMS that deals with pharmaceutical documents is not just a virtual file directory. A good DMS can be defined as the system that successfully manages all phases of document lifecycle from creation, through validation, to issuance, adjustment, distribution, teaching, storing, retaining and destroying it.
The usefulness of using DMS can easily be seen during the inspection of the business. The inspector may ask about various SOPs and if the employees were trained in accordance with the current standards. The successful Document Management System will be able to answer all these questions easily.
Pharmaceutical documents that can be contained and controlled by DMS are:
Without proper document management, companies might face the following problems:
In general, the document undergoes the following processes:
Draft → Review → Approval → Effective → Revision → Obsolete → Archive
Control measures should be in place for every stage.
For example: during the drafting process, the authorized personnel creates a document in an approved format. Next, the document goes through a technical review and quality review, which results in its approval.
Once the document is approved, it comes into force. If there is a necessity to make any amendments, a new revision will be created instead of modifying the approved version of the document.
The previous version of the document will have to be marked as obsolete and this will be done according to the organization’s record-retention policy.
Every document has to have its own unique ID identifier and revision status, for instance:
SOP-QA-015, Revision 04
The software must preserve the connections between versions so that the following questions can be answered:
For example, changing the name of the file from “SOP Final” to “SOP Final Updated” is a poor way of managing the documents.
Depending on the document, the reviewer list can comprise representatives from:
Electronic approval processes ensure proper documentation by recording the identity, date and time of the approval.
Nevertheless, it is recommended that electronic signatures and approval processes are appropriately controlled and verified when necessary.
The distribution of paper documents should be controlled by using some of the following methods:
Whenever a new SOP is introduced, the company has to determine if trained/hired staff require training.
The efficient knowledge management software can work with learning management software allowing the training to start.
SOP Revision → Approval → Training → Implementation
This connection gives strong proof that the personnel is trained before the procedure is applied.
Access rights should depend on the job of each employee.
The system should regulate:
The modifications made unauthorizedly provide a major threat to the integrity of the document.
It must be ensured that periodic review doesn’t turn into routine administrative job of reviewer signing documents stating that the document is still valid without any proper evaluation.
The following aspects should be taken into consideration during the review:
In this connection, it is important that the Document Management System provides:
Different types of control with regard to:
Typical deficiencies are as follows:
The organization should first define:
The best systems link document control to change control, training, quality improvements and data authenticity, preventing embedded processes from use in the future and assuring protection of past records as well as effective evidence provision during inspections.
To evaluate and determine whether a DMS is helpful one can put just one question: Has the organization the ability to state, without relying on memories or informal records, which document has been approved, its authentic version, who approved it, what changes were made and whether the staff in charge was trained? If any organization is able to answer these questions quickly and precisely, it has DMS which supports Pharmaceutical Quality System rather than just storage of documents.
The DMS that deals with pharmaceutical documents is not just a virtual file directory. A good DMS can be defined as the system that successfully manages all phases of document lifecycle from creation, through validation, to issuance, adjustment, distribution, teaching, storing, retaining and destroying it.
The usefulness of using DMS can easily be seen during the inspection of the business. The inspector may ask about various SOPs and if the employees were trained in accordance with the current standards. The successful Document Management System will be able to answer all these questions easily.
What Is a Document Management System?
A Document Management System (DMS) allows the process of creating, reviewing, approving, issuing, distributing, maintaining, retrieving and archiving documents to take place within a controlled environment.Pharmaceutical documents that can be contained and controlled by DMS are:
- Standard operating procedures
- Specifications
- Policies
- Instructions for work
- Protocols
- Validation documentation
- Master manufacturing documentation
- Forms and templates
- Quality manuals
- Test methods
- Reports
- Documents in training
Why Pharmaceutical Corporations Require a Document Management System
The main aim is to establish document control, but an efficient DMS should also ensure compliance and improve operational effectiveness.Without proper document management, companies might face the following problems:
- Outdated Standard Operation Procedures (SOP) in place
- Improper documentation system
- Not providing record of approval
- Different versions of the document
- Distribution process not properly controlled
- Delayed document examination
- No training for the employees after the document is modified
- Problems obtaining historical document
Document Lifecycle Management
It is important to ascertain that the document lifecycle is described accurately.In general, the document undergoes the following processes:
Draft → Review → Approval → Effective → Revision → Obsolete → Archive
Control measures should be in place for every stage.
For example: during the drafting process, the authorized personnel creates a document in an approved format. Next, the document goes through a technical review and quality review, which results in its approval.
Once the document is approved, it comes into force. If there is a necessity to make any amendments, a new revision will be created instead of modifying the approved version of the document.
The previous version of the document will have to be marked as obsolete and this will be done according to the organization’s record-retention policy.
Document Creation and Version Control
Version control is among the crucial functions of document management software.Every document has to have its own unique ID identifier and revision status, for instance:
SOP-QA-015, Revision 04
The software must preserve the connections between versions so that the following questions can be answered:
- What changed in this document?
- Why was it changed?
- Who checked it?
- Who approved it?
- When did it come into effect?
- Which version of the document was it before?
For example, changing the name of the file from “SOP Final” to “SOP Final Updated” is a poor way of managing the documents.
Review and Approval Workflow
A regulated DMS has to have predefined review and approval processes.Depending on the document, the reviewer list can comprise representatives from:
- Quality assurance
- Production
- Quality control
- Engineering
- Validation
- Regulatory Affairs
- Information technology
Electronic approval processes ensure proper documentation by recording the identity, date and time of the approval.
Nevertheless, it is recommended that electronic signatures and approval processes are appropriately controlled and verified when necessary.
Controlled Distribution
The distribution of a document requires it to be available for usage wherever needed. For electronic documents, this may include controlled-access systems with the provision for users to obtain only authorized copies of a document.The distribution of paper documents should be controlled by using some of the following methods:
- Identifying controlled copies
- Distribution list
- Records of distribution
- Collecting obsolete copies
Training Integration
The revision of manuals should correspond to the training of workers.Whenever a new SOP is introduced, the company has to determine if trained/hired staff require training.
The efficient knowledge management software can work with learning management software allowing the training to start.
SOP Revision → Approval → Training → Implementation
This connection gives strong proof that the personnel is trained before the procedure is applied.
Access Control
Not all employees should have unfettered access to controlled documents.Access rights should depend on the job of each employee.
The system should regulate:
- Who can create documents
- Who can modify drafts
- Who can review documents
- Who can authorize documents
- Who can issue documents
- Who can see archived documents
- Who can manage the system
The modifications made unauthorizedly provide a major threat to the integrity of the document.
Periodic Document Review
The documents should periodically go through the process of review specified in the organization.It must be ensured that periodic review doesn’t turn into routine administrative job of reviewer signing documents stating that the document is still valid without any proper evaluation.
The following aspects should be taken into consideration during the review:
- Changes taking place in the regulatory environment
- Changes relating to the process carried out
- Any deviations
- Corrective actions|
- Finidings of audit
- Changes in the equipment
- Changes in technology
- The history of performance of documents from the past
Document Retention and Archiving
There are specific time periods for which obsolete documents and GMP records may need to be retained.In this connection, it is important that the Document Management System provides:
Different types of control with regard to:
- Retention periods
- Archiving
- Retrieval of documents
- Protection of documents
- Making backups
- Recovering from disasters
- Controlled destruction
Common Document Management Issues
The presence of software does not guarantee that there is, in fact, a sound document management system.Typical deficiencies are as follows:
- Undefined workflows
- Users given too many permissions
- Poor change management
- Few audits
- Accessibility of outdated documents
- No tracking of training related to document revisions
- Weak validation
- Poor back-up plans
- Existence of duplicated documents not under management
Implementing an Effective Document Management System
A productive implementation must start with the business and GMP needs instead of software functionalities.The organization should first define:
- Types of documents and ownership.
- Approval process.
- Revision control.
- Requirements on access.
- Training needs.
- Retention requirements.
- Requirements for audit trail.
- Requirements for electronic signature.
- Security of backups and disaster recovery.
- Validation requirements.
The best systems link document control to change control, training, quality improvements and data authenticity, preventing embedded processes from use in the future and assuring protection of past records as well as effective evidence provision during inspections.
To evaluate and determine whether a DMS is helpful one can put just one question: Has the organization the ability to state, without relying on memories or informal records, which document has been approved, its authentic version, who approved it, what changes were made and whether the staff in charge was trained? If any organization is able to answer these questions quickly and precisely, it has DMS which supports Pharmaceutical Quality System rather than just storage of documents.
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