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