How does your organization manage important documents like policies and specifications?
If you thought of a person or envisioned a gigantic three-ring binder, it’s time to upgrade your document management approach.
Smart manufacturing processes and sophisticated supply chains need to be backed-up by intelligent document solutions.
Digital document solutions reduce some of the stress associated with FDA inspections and ISO audits and position your company for growth.
As you add locations or product lines, it’s easier to keep the company aligned digitally.
Digital solutions offer three distinct advantages over paper-based processes: compliance, control and collaboration.
Document management tools automate some of the safeguards required by the FDA and EU regulators, such as provisions for signatures.
Electronic signatures become clearly linked to a single document and document stage (such as review or approval). Business rules can be enforced to make sure the guarantor has the right authority to sign-off.
And with a single repository, staff from anywhere in the business can quickly and confidently access the right version of a policy, procedure or training document.
In contrast, paper files are prone to mistakes. Even simple errors – like illegible handwriting or an incorrect date – could put operations at risk. When an auditor shows up, staff could grab the wrong file from a cabinet, or the correct document could be stuck on someone’s desktop.
Paper files are difficult to protect.
In print, proprietary information can be copied, misplaced or shared inappropriately (intentionally or not).
With digital solutions, companies gain greater control over their information. With electronic systems, printing and downloading can be restricted.
Document rules can be configured to match your business and compliance practices – and then enforced automatically, without the risks associated with human error or judgement.
Dozens of departments and people are affected by every document. Collecting input and disseminating final documents – correctly and efficiently – is difficult to manage via email or folder-based sharing systems.
And, the risk is too high that someone will reach for an outdated version during an inspection.
Companies need a single repository for documents, clearly identified as “final” or by their current status.
Each document impacts a large number of people and processes, so a lot of stakeholders need to provide input before a document becomes final. Managing reviews can be a nightmare via email or a folder-based sharing system.
Digital document management systems house all of the changes and comments submitted by stakeholders, so their input is documented and shared with the entire team.
And multiple reviewers can work on a document at the same time, eliminating version-control issues and endless cycles of review.
Most digital solutions also include search features or ways to link files, so it’s simple to find related documents (like training plans) that are affected by changes in process.
With digital document management solutions, a file’s status is clear, as are the next steps. Everyone stays on the same page and understands their role in the process.
What’s more, the benefits of digital document management can be automated.
Once you set up a workflow, a digital document management system can automate the next steps. Stakeholders will automatically be triggered when they need to act, when a document is nearing expiration or there’s a change to a standard operating procedure.
Some document management systems integrate with quality management activities such as corrective and preventive actions.
When document workflows are standardized and automated, you don’t have to fear discrepancies in documentation across the organization. You’ll have one less thing to worry about.