Document Control | Processes and Practices
Document control enforces document review process standards and provides a complete audit trail of activities.
Document control procedures provide "chain of custody" quality control for documents that transfer between parties, including internal documents, external documents, and quality records. A document control system refers to the overall set of procedures that govern this.
Organizations wanting to comply with ISO 9001 or 21 CFR Parts 210 and 211 must establish a documented standard operating procedure (SOP) for this document control procedure.
Drafted documents go through a series of document reviews and approval gates where stakeholders provide comments, corrections, changes, etc. All activities related to the document and all versions of the document are tracked in the system and can be audited.
A document control system must provide a system for regular review of documents based on a schedule or as the organization goes through major changes that may impact the content of the documents. This can be managed by a central "document controller" who bears the responsibility of ensuring the review process is handled properly.
A revision audit trail is needed to ensure any changes are clearly identified and time/date stamped along with the identity of the person responsible for the revision.
All relevant staff should be able to find and retrieve a document version from any point in the change cycle. In addition, relevant staff should be notified of changes to the document.
This refers to the fact that documents are readable and findable by a document locator, which means consistent readable formats (digital or handwritten) and document naming/coding procedures. A document controller can design and implement a naming and storage process that makes sense to the organization.
Documents from outside contractors and agencies should be treated the same way internal documents are treated in terms of review and distribution.
It must be clear to any document user which is the most recent, usable version of a document and which documents have been retired and must stay out of circulation. These retired documents can be destroyed, archived or otherwise marked as unusable as part of their document management.
All of these document control policies and procedures need to be documented which includes written descriptions, flowcharts, schedules, plans, etc.
Workflow automation allows document teams to design and deploy customized, automated document routing workflows that ensure standardized procedures are followed every time a document is created or reviewed.
Alerts, notifications, escalations, and reminders ensure that controlled document actions are taken appropriately and in a timely manner. Scheduled reminders, for instance, can be set to trigger document reviews at specific intervals. These reminders can be sent to individuals, alternate approvers, or groups to ensure coverage.
An audit trail provides verifiable, complete evidence that a sequence of tasks or activities have been performed as part of a standard process or operation. All activity is clearly time-, date-, and user-stamped for consistent reporting internally and externally.
All documents are retained in the system at the point they are uploaded, in their current state. Subsequent versions are also retained, allowing an audit to display a document at any point in time. Metadata collected via forms regarding the document is retained and associated with the document as well.
Document workflows can be built to capture and route documents form external agencies and vendors. The same rules and retention options are available to these external documents as if they originated internally. Access by outside users can be controlled with user access settings.
Detailed process maps can be shared with staff, vendors, and regulators showing that standardized quality assurance and document control procedures are in place as well as how they operate.
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