Web Document Management and a cGMP-Compliant Quality System: Management Responsibilities
Marci L. Crane
January 03, 2009
The underlying foundation of any quality system is its associated documentation. Quality system documentation includes policies, procedures and written processes (e.g., quality assurance documentation, SOPs, etc.) and provides the proof that a quality system does or does not meet documented expectations.
Because documentation is the foundation and assurance of an accurately applied quality system it is probably safe to assume that those companies that manage and manipulate their documentation faster and more effectively at the enterprise level have an increased ability to more effectively manage their overall quality system.
Enterprise Level Web Document Management
Depending on the industry in question, a quality system will generally require a variety of documented policies and procedures that must be approved, stored, and/or presented to remain in a state of compliance. The life science industries, for example--especially the pharmaceutical industry--are very highly regulated (by the FDA and other regulatory agencies or standards organizations) and require the strict management of quality system documentation, product lifecycle documentation and those documented forms required for formal submissions (these can equal hundreds of thousands or millions of documents in the pharma industry).
Modern Quality System Elements
The FDA's guidance for the pharmaceutical industry, Quality Systems Approach to Pharmaceutical cGMP Regulations1 presents the necessary elements of a modern quality system (includes harmonized international standards, ISO 9000 elements, etc.) and connects those elements with cGMP standards required since the 70s by the FDA. The guidance provides a modern quality systems model2 that includes the following categories:
Each of these quality system categories can be managed and controlled more effectively with the use of an enterprise-level web document management system. This article, however, will focus primarily on management responsibilities and how web document management software can greatly amplify and executive's ability to keep a quality system in check.
Management Responsibilities
According to the FDA's guidance, Quality Systems Approach to Pharmaceutical cGMP Regulations, a "Modern robust quality systems models call for management to play a key role in the design, implementation, and management of the quality system."
Even from the initial stages of quality system creation, management is presented with the required responsibility of participating in the design of a company's quality system. This documentation, according to the guidance may include the following:
When these and other forms of documentation need to be created and presented, management is called to task. To create these documents in a manner efficient enough for even the busiest of executives, a web document management solution should be implemented so that document collaboration can take place and so that documents can be automatically routed to users of all departments for collaboration and review. Audit trails will also make it easy to see when, where and by whom a document has been modified.
System Review
Another "must" for management is to review the company quality system on a regular basis. According to the guidance, Quality Systems Approach to Pharmaceutical cGMP Regulations, "Under a quality systems approach, a review should consider at least the following:"
All of these requirements can be conducted with electronic web-based process management software and with the following capabilities:
The Trick
The trick for managing all of these requirements electronically is to find the software provider that can provide all of the solutions mentioned above on one web-based platform.
References
1-3. http://www.fda.gov/CDER/guidance/7260fnl.htm
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regard to web document management solutions, please feel free to contact a MasterControl representative.
Because documentation is the foundation and assurance of an accurately applied quality system it is probably safe to assume that those companies that manage and manipulate their documentation faster and more effectively at the enterprise level have an increased ability to more effectively manage their overall quality system.
Enterprise Level Web Document Management
Depending on the industry in question, a quality system will generally require a variety of documented policies and procedures that must be approved, stored, and/or presented to remain in a state of compliance. The life science industries, for example--especially the pharmaceutical industry--are very highly regulated (by the FDA and other regulatory agencies or standards organizations) and require the strict management of quality system documentation, product lifecycle documentation and those documented forms required for formal submissions (these can equal hundreds of thousands or millions of documents in the pharma industry).
Modern Quality System Elements
The FDA's guidance for the pharmaceutical industry, Quality Systems Approach to Pharmaceutical cGMP Regulations1 presents the necessary elements of a modern quality system (includes harmonized international standards, ISO 9000 elements, etc.) and connects those elements with cGMP standards required since the 70s by the FDA. The guidance provides a modern quality systems model2 that includes the following categories:
- Management Responsibilities
- Resources
- Manufacturing Operations
- Evaluation Activities
Each of these quality system categories can be managed and controlled more effectively with the use of an enterprise-level web document management system. This article, however, will focus primarily on management responsibilities and how web document management software can greatly amplify and executive's ability to keep a quality system in check.
Management Responsibilities
According to the FDA's guidance, Quality Systems Approach to Pharmaceutical cGMP Regulations, a "Modern robust quality systems models call for management to play a key role in the design, implementation, and management of the quality system."
Even from the initial stages of quality system creation, management is presented with the required responsibility of participating in the design of a company's quality system. This documentation, according to the guidance may include the following:
- "The scope of the quality system, including any outsourcing (see IV.B.4.)"
- "The quality standard that will be followed"
- "The manufacturer´s policies to implement the quality systems criteria and the supporting objectives (see IV.A.4.)"
- "The procedures needed to establish and maintain the quality system"3
When these and other forms of documentation need to be created and presented, management is called to task. To create these documents in a manner efficient enough for even the busiest of executives, a web document management solution should be implemented so that document collaboration can take place and so that documents can be automatically routed to users of all departments for collaboration and review. Audit trails will also make it easy to see when, where and by whom a document has been modified.
System Review
Another "must" for management is to review the company quality system on a regular basis. According to the guidance, Quality Systems Approach to Pharmaceutical cGMP Regulations, "Under a quality systems approach, a review should consider at least the following:"
- "The appropriateness of the quality policy and objectives"
- "The results of audits and other assessments"
- "Customer feedback, including complaints"
- "The analysis of data trending results"
- "The status of actions to prevent a potential problem or a recurrence"
- "Any follow-up actions from previous management reviews"
- "Any changes in business practices or environment that may affect the quality system (such as the volume or type of operations)"
- "Product characteristics meeting the customer´s needs"
All of these requirements can be conducted with electronic web-based process management software and with the following capabilities:
- Document Collaboration
- Audit Management Software
- Customer Complaints Management Software
- Nonconformance, Deviations and other Trend Solutions
- CAPA Software
- Change Control Software
- Easy Search and Retrieval Capabilities for all Documentation and Forms
The Trick
The trick for managing all of these requirements electronically is to find the software provider that can provide all of the solutions mentioned above on one web-based platform.
References
1-3. http://www.fda.gov/CDER/guidance/7260fnl.htm
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regard to web document management solutions, please feel free to contact a MasterControl representative.
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