Required Roles: Editor, Reviewer
Required Permissions: View
Controlled Document List Report
The Controlled Documents report is pre-configured. Typically, SOP, work instructions, policies, quality manuals, forms and templates.
Controlled Documents fall under the following regulations: ICH Q10 and Current Good Manufacturing Practices (cGMP) from FDA.
Reports that use a subset of the Controlled Document List Report include the SOP List report and SOPs expiring in Next 60 Days Report.
Covered in this article:
Use Cases: examples on how to utilize the report.
Filters: use to create specific subsets of data in the report.
Columns: use to sort data in the report.
Use Cases
Use Cases for Controlled Document Reports:
Organization-wide Audit: Identify the total number of controlled documents, their status (e.g., approved, effective, expired/expiring), authors, and associated departments.
External Audit: Provide external auditors, either regulatory or customers, with a full or filtered list of all controlled documents, depending on the audit scope or requirements.
Resource Planning: Analyze document volume by category and type to assess team workload and support scheduling decisions.
Filters
Filters are used to narrow the data. Filters used in the reports can also be configured. Filters used in the example below include: Artifact, Category, Effective Date, Expiration Date, and Approved Date.
a) Artifacts
Artifacts represent document types. Names and types are configured per implementation and organization. Artifacts are defined as children of a Category.
Artifact: In the example to the right, Artifact describes the type of controlled documents available in the configuration to run the report. |
b) Category
Categories reflect broad content areas in the organization or Quality departments. Specific names of the categories are configured per implementation and organization. Categories are a child of a document type and a parent to an artifact.
Category: In the example to the right, Category describes the subject that the controlled document pertains to. Audit, Clinical Operations, Policy and Procedure, Information Security and Technology or Quality Assurance are available OOTB. |
c) Effective Date
Effective date typically refers to the date a policy, work instruction, SOP or other controlled document is approved and available for general consumption in the organization. As part of an overall Quality Management Program and Policy the "Effective Date" should be clearly defined by the organization.
Effective Date: In the example to the right, effective date applies a range of days, weeks, months or years with a drop-down list. |
d) Expiration Date
Expiration date represents a future date where a set or specific controlled document will either no longer be effective or will be part of a review cycle for periodic updates. Expiration date setting is typically part of an overall Quality Policy.
Expiration Date: In the example to the right, the Expiration Date dropdown menu lists actual dates of expiration to choose. |
Columns
Data and information in the columns may be sorted to provide a different view of Controlled Documents. Clicking on the Column title will sort the items ascending or descending.
In the example below, columns include Control Number, Document Name, Version, Effective Date, Expiration Date, and Approved Date.
Control Number: Organizational reference to a document. Configurable per implementation and organization.
Document Name: Short descriptive title.
Version: DMS auto-applied number applies to a specific variation of a document/content.
Effective Date: Defined generally as the date a policy, work instruction, SOP, or other controlled document is approved and available for general consumption in the organization. As part of an overall Quality Management Program and Policy, the "Effective Date" should be clearly defined by the organization.
Expiration Date: Represents a future date when a set or a specific controlled document will either no longer be effective or will be part of a review cycle for periodic updates. Expiration date setting is typically part of an overall Quality Policy.
Approved Date: The Date a specific version of a document was approved. This typically marks the end of the review and approval process. However, definitions may vary depending on your organization's specific workflows and how document states (e.g., approved, effective, expired) are defined.