Most quality management personnel discover they’ve had document control problems at the worst possible moment: during an audit, after a compliance breach, or when critical standard operating procedures (SOPs) have gone missing. The scramble to implement proper processes begins under pressure.
For organisations operating under ISO 9001, Good Manufacturing Practice (GMP) or similar frameworks, document control is the foundation of quality assurance. Yet many companies still rely on manual document management workflows that create bottlenecks, increase error rates, and make it hard to prepare for audits.
Let's break down exactly where traditional document control goes wrong and what happens when companies use a document management system (DMS) like DocuWare to get it right.
Most quality managers know the frustration of people working from outdated files and ‘simple’ changes becoming complex email trails. These are symptoms of fundamental flaws in the document control process.
Companies still relying on manual approaches to manage quality assurance documentation will often experience:
In a typical document approval workflow, a quality manager creates a new SOP, emails it to reviewers, and waits for feedback. They then consolidate comments, send the revised versions, track down signatures, and finally distribute the approved document.
This manual approach creates cascading problems. Each step requires manual intervention. Each handoff risks delay. Critical updates often get lost in email chains, while version confusion can lead to outdated procedures remaining in use.
Without centralised document control, quality managers operate with incomplete information. They cannot quickly determine who last accessed files, which documents require periodic review, or whether all departments are using the current versions.
This visibility gap creates dangerous blind spots. Departments may work from different document versions, or training may reference outdated procedures. Each disconnect increases the risk of non-compliance and quality issues.
The problem compounds across larger companies. When quality documentation spans multiple sites, departments and systems, maintaining control becomes exponentially more difficult.
For many quality teams, audit preparation is the largest recurring challenge. People often scramble to locate documents, reconstruct approval histories and compile compliance evidence.
Regulatory bodies often cite documentation failures as a reason for non-compliance penalties. Beyond financial impact, documentation failures damage reputation, erode customer trust and can lead to loss of certifications.
DMS systems like DocuWare create a centralised repository for all your quality management documentation. This single source of truth eliminates version confusion.
Not only that, DMS software helps you use centralised documents to greater effect. Intelligent indexing automatically categorises documents based on type, department or process. Full-text search capabilities mean finding specific information takes seconds.
Centralising document control also improves analytics. You can identify overdue reviews, track document usage patterns and spot potential gaps in coverage. This visibility transforms your processes from reactive document control to proactive quality management.
Automatic document control ensures consistency. Every document follows the same rigorous process, regardless of who initiates it. In larger organisations, if a change affects multiple departments, DMS software can incorporate sequential or parallel approvals, based on predefined rules.
Onboarding DMS software will significantly enhance your document approval workflows. For example, when a new SOP requires sign-off, your DMS automatically routes it to designated reviewers based on the document type, department or content.
If the reviewer doesn't respond, the system escalates it to their supervisor. Once all approvals are complete, the system archives the previous version and distributes the updated version to relevant personnel.
Outdated documentation is one of quality control’s greatest enemies. Digital document management systems prevent this by maintaining complete version histories, ensuring that only current versions remain accessible for general use.
DMS technology tracks every change with meticulous detail: who made modifications, when changes occurred, what specifically changed, and why updates were necessary. Previous versions remain accessible for audit purposes but cannot be mistakenly used in operations.
When sending specifications to suppliers or procedures to contractors, DMS software ensures they receive the current versions. This eliminates the risk of external parties working from out-of-date information.
With comprehensive document control, you’re always prepared for an audit. Every document maintains its complete metadata, including its creation date, revision history, approval chain, distribution list and access logs.
When an auditor requests evidence, you can instantly provide it. If questions arise about approval processes, complete workflows are available with timestamps and electronic signatures.
Greater productivity and strategic focus:
Reduce risk across the board:
Make data-driven decisions:
Gain a competitive edge:
Pharmigon manufactures patient-specific cancer treatments where documentation accuracy can literally mean life or death. Operating under strict GMP requirements, they process 50 production protocols daily, each containing hundreds of pages requiring multi-stage verification.
With DocuWare, Pharmigon has transformed its document control, enabling:
“In our organisation, DocuWare is seamlessly integrated with our industry solution. This has enabled us to meet the strict requirements of GMP-compliant production, efficiently and in a user-friendly manner,” says Lejla Razic, Pharmacist and CEO, Pharmigon.
Pharmaceutical manufacturer uses DocuWare to manage over 200,000 documents, each of which is instantly accessible and fully traceable.
SALUS Group: Coordinating quality across borders
Operating across 13 countries with 11 companies, SALUS faced the challenge of maintaining consistent quality standards despite geographical and organisational complexity. Their legacy systems created information silos that prevented effective oversight and standardisation.
Using DocuWare’s quality management solutions has enabled SALUS to:
"There are often discrepancies between the supplier invoice and the original order. In the past, our employees had to slog through up to forty pages to find the error. Today, DocuWare completes this task in a fraction of a second," explains Gregor Jenko, Member of the Board, SALUS Group.
Read SALUS Group’s story in full.
Begin by outlining your current document control processes and identifying pain points. This baseline will enable you to make ROI calculations when you’re reviewing DMS systems and will help you to prioritise implementation areas.
Shortlist and choose a document management system that aligns with your quality framework requirements. Ensure your chosen system can implement workflows that mirror your approval processes, while also building efficiency improvements.
If you want to roll out document control in phases, start with high-impact areas, such as SOP management or audit preparation. This focused approach will allow you to refine your document management processes and build confidence through early wins.
You can then expand your DMS software across departments and document types. Each phase should include thorough training and be mapped to clear success metrics.
The more attention you pay to your DMS software, the better return you’ll get from your investment. Monitor your system usage, gather user feedback and identify opportunities to improve workflows and processes. Regular reviews ensure the system evolves with your quality management needs.
We've helped organisations like Pharmigon and SALUS Group automate their document management. Now, we can fix your document control for faster approvals, stress-free audits and a focus on improvement instead of paperwork.
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Learn more about Quality Management solutions here.