Key Takeaways
- Good document management means current, error-free documents, on-time approvals, tight data security, and regular reviews.
- Key changes to approval timelines, workflows, user access rights, and periodic reviews can improve document management.
- The best document management software systems all share four critical features.
What is good document management?
Document management is the process of creating, storing, maintaining, and retrieving all of the documents your organization needs to function – and it’s a huge piece of a Quality Manager’s role. The entire document lifecycle managed by the Quality team usually includes:
- Drafting: Creating new documents (such as SOPs), sometimes with the help of SMEs.
- Review/approval: Getting the right stakeholders to review drafts and managing the document through the required approval workflows.
- Version control: Revising documents as necessary, tracking changes, and making sure only the most up-to-date versions are accessible.
- Storage and distribution: Keeping documents organized, secure, and available to the people who need them (and only to the people who need them).
- Document retiring: Archiving old/outdated documents so they’re no longer in circulation, but still accessible for audit trails and regulatory inspections.
Document management takes a lot of time and effort, especially for GxP-regulated organizations which often have 500 documents or more to maintain. That’s a tall order for small Quality teams, and even just one missing document or inappropriate user access permission could lead to major regulatory consequences.
That’s why it’s so important to have a solid document management and document control foundation.
Good document control means:
- Your documents are up-to-date and error-free
- Only the most current, relevant documents are accessible
- User access is limited so only the right documents are accessible by the right people
- There are no duplicate documents
- There are no overdue document approvals or revisions
How can Quality departments improve document management?
It’s not unusual to struggle with GxP document management, but there are steps Quality teams can take to improve overall document control and prevent issues before they happen.
Set a standard document approval timeline
One of the simplest ways to improve document management is to introduce a clear, consistent document approval timeline. For example, a policy that states every Standard Operating Procedure (SOP) will be approved within 14 days.
Why does this matter? Documents are updated for a reason, whether to address an issue or implement a better process, and you don’t want them to stay in limbo. Delayed approval means delayed training. Delayed training means a delayed effective date. And that means more time for an issue to spiral out of control.
There is no industry-wide standard document approval timeline – it all depends on your organization’s needs and the complexity of your workflows. A critical SOP update may require sign-offs from multiple stakeholders (e.g. Quality, Regulatory, maybe even the CEO), and therefore require a longer approval window. Smaller organizations or minor version updates may mean a workflow that only needs one or two signatures, and the approval timeline can shorten significantly.
Just a small portion of the document lifecycle data available via the Insights module in ZenQMS.
Review your document control workflows
Your document control workflows define who approves what, which steps are required for which document categories, how major and minor revisions are handled, and how to retire a document. If you haven’t reviewed your workflows in a while, it’s likely there’s more than a few opportunities to simplify and streamline your process.
While reviewing, ask yourself:
- Do your workflows match the needs of your document categories? If you have one workflow that handles all document categories and all revision types, you’re probably adding unnecessary complexity to your process. Use the severity of revisions, the importance of the content, and the ultimate goal of the document to inform how many steps are actually needed.
- Do you have the right people approving the right documents? Make sure each document category routes only to the stakeholders who truly need to sign off. Redundant or unnecessary approvals can slow things down a lot.
The goal here is to comply with GxP regulations while keeping things as simple as possible. Above all, your workflows should be consistent, clear, and compliant – three building blocks of good document management.
Stick to your periodic review schedule
Even the best documents need periodic review to stay relevant. Regulatory environments change, internal processes evolve, and what worked a year ago might not be the best practice now. That’s why periodic reviews are required for GxP-regulated organizations.
But the real key is completing your periodic reviews on time. Quality teams have more than their fair share of deadlines to keep track of, and it’s not hard for dates to accidentally slip by. This is where a good document management software comes in.
The right tool will keep track of your periodic review schedule and provide easy-to-read charts so you can see what’s overdue – and how long it’s been overdue – at a glance.
Review your user access rights
Maybe the most critical part of GxP document control is user access management. You don’t want just anyone downloading, editing, or even seeing certain documents. Not only does this protect PHI and PII, it also makes sure only the most accurate, effective SOPs are referenced. Granular access controls are essential.
As part of your document management process improvement, review your user access controls by:
- Assigning permissions carefully: Be specific and critical when setting user access rights. For instance, someone on the lab floor may only need to view certain SOPs and not have the ability to edit or retire them.
- Restricting downloads: Restrict or disable downloads where possible. If it’s not necessary for someone to have a local copy, don’t let them download it. This makes it easier to confirm all retired documents are out of circulation and only the most up-to-date SOPs are used.
- Conducting regular access rights audits: Set up regular access rights audits – such as one every six months – to check that all roles and document permissions are correct. If you spot discrepancies (like an employee who has left the company but still has system access) you can correct them before the situation gets catastrophic.
Example document management goals
How do you make sure you’re on the right path to improve document management?
You set goals and track KPIs, of course. Here are a few examples of document management goals your Quality Management team may want to define:
- X% of documents approved on time: Hold yourself – and the other departments – accountable for document approvals with a set on-time approval goal. Adjust the percentage based on your historical data and the improvement you want to see.
- Complete X% of periodic reviews on time: If you don’t already have one, develop a system to remind your team when periodic reviews are approaching – or better yet, get a document management system (like an eQMS) that can keep track and send reminders for you.
- Have no more than X% of periodic reviews more than 29 days past due: Delays happen. But if you can’t conduct a periodic review by the exact due date, limit how long it stays open. Setting a limit means you still catch and correct overdue documents relatively quickly.
- Conduct a user access rights audit every 6 months: If you don’t already have a user access audit schedule in place, make it a goal to create one this year.
The best document management software for GxP organizations
No matter how well-defined workflows and goals are, Quality teams still rely on individual stakeholders to follow through. Ultimately, it’s up to everyone in the organization to approve documents on time, train when necessary, and keep to established processes. That’s why the right document management software can be a game changer. It helps automate, streamline, and enforce the workflows you’ve worked so hard to design.
When it comes to document management software, Quality teams have options. For the most compliant, secure, and effective solution, most choose either an eDMS (electronic document management system) or an eQMS (electronic quality management system).
- eDMS: An eDMS is a software platform specifically for document management – and only document management. With an eDMS, you can create, revise, and store important documents like SOPs, work instructions, and training manuals, but other quality functions like training or CAPA management will need a separate system.
- eQMS: An eQMS is a one-stop shop for everything from document control and training records to managing audits and change controls. If your Quality department oversees anything beyond document management, you’ll likely want an eQMS to help integrate your processes.
Whichever you choose, the best document management software for GxP organizations will have these features:
- Granular Access Controls: Not all software platforms approach access controls the same way. Pick a platform that allows you to limit access by user role, department, or even specific documents.
- Automated Notifications: Built-in reminders for approvals, periodic reviews, and training tasks help eliminate the human error factor. Bonus tip: Look for a system where these notifications can’t simply be turned off by the end user.
- Flexible Workflows & Document Categories: Some platforms have preset document categories and rigid workflows. This means you have to adjust your tried-and-true processes to match the system – not ideal. Instead, find a document management tool that lets you configure categories and adapt workflows to meet your needs.
- Insights & Reporting Capabilities: You can only improve what you can measure, so be sure your document management software has the ability to track and report on critical data. This helps you monitor approval timelines, detect overdue reviews, and pinpoint the areas where bottlenecks are frequent.