Lost in a maze of paperwork?
It feels almost impossible to keep track of critical quality documents when you’re relying on manual systems or scattered digital folders.
Chasing down files for audits wastes so much time and exposes your company to compliance risks that could be avoided.
According to Uhura Solutions, employees can spend as much as 30% of their time searching for documents when files are disorganized or stored in too many places. Imagine how much smoother your workflow would be if everything was right where you needed it.
This article is here to help you cut through the chaos and finally gain control of your quality documentation.
In this article, I’m going to walk you through the 11+ best document management software for quality control that will keep you audit-ready, compliant, and efficient.
You’ll find practical solutions for version control, streamlined approvals, and tight integration with your QMS.
Let’s dive in.
Quick Summary:
| # | Software | Rating | Best For |
|---|---|---|---|
| 1 | FileCenter → | Small to mid-size manufacturers | |
| 2 | ComplianceQuest → | Life sciences organizations | |
| 3 | ETQ Reliance → | Enterprise quality-driven teams | |
| 4 | SimplerQMS → | Small life sciences teams | |
| 5 | MasterControl → | Large regulated enterprises |
1. FileCenter
Is your document chaos holding back quality audits?
FileCenter’s automated filing and version control tackle messy document organization, making it a solid pick for those needing bulletproof compliance and easy document retrieval.
If you’re constantly chasing after updated SOPs or tracking down which version your auditor needs, you’ll appreciate how FileCenter can keep every quality control document organized and audit-ready in seconds.
Here’s what makes the difference.
FileCenter brings together powerful automated filing and robust version control to solve your biggest compliance headaches. This means your quality control files are sorted using rules you set, and every change is captured in a full revision history, making audits much easier.
Plus, with advanced search, you can quickly locate any file by keyword, document content, or even metadata. If your team is drowning in paperwork or struggling to prep for audits, you’ll see how automated document sorting and change tracking give you control. That way, you’ll never waste time digging for a record when you’re under pressure.
Additionally, FileCenter’s quick access means you won’t miss deadlines when quality issues pop up. Having one system that covers document control, version tracking, and audit trail is a total game-changer for your QC process.
Your quality documentation is always at your fingertips.
Key features:
- Automated document filing with custom rules and metadata so your quality control paperwork is always consistently organized, searchable, and ready for audit with almost no manual intervention required.
- Full version control tracks every document change and makes it simple for your team to revert, reference, or prove revision history to regulatory auditors or management.
- Advanced multi-criteria search empowers your quality control staff to instantly access the exact documents or records they need using keywords, full-text, or built-in metadata.
Verdict:
FileCenter stands out as a best document management software for quality control option with automated filing, full version control, and lightning-fast search. If your team needs organized, audit-ready files on demand, FileCenter can cut QC document prep time by up to 80%.
2. ComplianceQuest
How do you keep quality documentation audit-ready?
ComplianceQuest’s document control capabilities help your team manage documents from creation through approval, ensuring only up-to-date versions get used for quality tasks.
With audit trails and electronic signatures, you’ll always have a documented chain of custody for every change, which is essential for regulatory compliance.
Maintaining audit-ready records can be overwhelming, especially when regulations like 21 CFR Part 11 come into play.
Here’s where ComplianceQuest comes in.
You can rely on ComplianceQuest to automate the full document lifecycle, from authoring and updating to obsolescence, so you’re always inspection-ready without extra manual effort.
It’s easy to see how this plays out in real life. With full document versioning and approval controls, your quality team can reduce the risk of someone referencing an obsolete procedure and avoid compliance slip-ups that might trigger findings in your next audit.
Plus, the built-in audit trail provides a tamper-proof record of document activities and changes — complete with electronic signatures — helping your company satisfy regulatory demands for data integrity and accountability.
You get peace of mind for every inspection.
Key features:
- Comprehensive document lifecycle management ensures control over document creation, revisions, approvals, distribution, and archival so your team always works from the right information
- Tamper-proof audit trail with electronic signatures supports regulatory requirements such as 21 CFR Part 11, giving you easy traceability and documented accountability during audits
- Cloud-based access and real-time collaboration tools empower your quality team to efficiently update documents, route approvals, and maintain compliance from anywhere
Verdict: If you need an excellent document management software for quality control, ComplianceQuest is hard to beat for regulated industries—especially life sciences. Its audit trail, version control, and 21 CFR Part 11 support make it a trusted choice to keep your documentation inspection-ready.
3. ETQ Reliance
Is document chaos keeping your quality team awake?
With ETQ Reliance, you get powerful document control with built-in versioning, review cycles, and approval workflows designed for compliance-sensitive environments.
The platform’s smart workflows help you reduce manual errors and quickly route critical quality documents where they need to go, so nothing slips through the cracks.
Here’s how it all comes together.
ETQ Reliance does more than store files—it gives you robust, cloud-based tools that solve quality documentation headaches at every stage.
You’ll love how it keeps everything organized, which means you can collaborate on documents in real time, track changes, and automatically enforce review and approval cycles. This takes the guesswork out of regulatory document control and helps your team stay audit-ready.
Another major win is its audit management feature. The system centralizes your audit scheduling, automates corrective action tracking, and keeps a full record, so you can always prove compliance. Plus, when issues pop up, you’ve got a clear digital trail to pinpoint and resolve problems fast, closing the loop on continuous improvement.
It all adds up to less stress and more predictable quality control.
Key features:
- Centralized document control for lifecycle management including versioning, review cycles, and secure approval workflows, helping your team maintain consistent compliance and reduce risk of manual errors.
- Automated routing and approval workflows that eliminate bottlenecks, so your quality documents move efficiently through each stage, ensuring your processes support compliance and productivity.
- Comprehensive audit management with corrective action tracking that helps you maintain continuous audit readiness and immediately address quality concerns for ongoing regulatory compliance.
Verdict:
ETQ Reliance is a smart pick as the best document management software for quality control thanks to its automated review cycles, centralized document control, and audit tracking capabilities perfect for quality-driven, compliance-focused teams aiming to reduce errors and pass audits efficiently.
4. SimplerQMS
Is audit readiness always on your mind?
SimplerQMS makes it easy to gain control over your document management process with built-in document review, approval workflows, and automated tracking of document versions.
This means you no longer have to worry about outdated or missing files causing compliance headaches. Automated version control ensures your team uses only current, approved documents at every stage, which is essential when you want to avoid errors, failed audits, or regulatory fines.
Let’s dive into how SimplerQMS delivers on this.
If you’re looking for a way to maintain compliance without all the manual hassle, SimplerQMS checks a lot of boxes. You get robust document control features designed for highly regulated teams, including support for secure electronic signatures that help meet 21 CFR Part 11 requirements. This means your document approval process is not only digital and traceable, but fully audit-ready at all times for regulators and customers.
Additionally, SimplerQMS lets you handle change control in one place, capturing every revision, approval, and decision point along the way. That way, you can show exactly who made changes and why, which makes responding to audits a breeze and gives your team true accountability.
The result is total confidence in your compliance processes.
Key features:
- Document control with review, approval, and versioning so only the most recent, authorized documents are accessible to your team, supporting audit readiness and process accuracy.
- Integrated electronic signatures meeting 21 CFR Part 11, letting you digitize approval with full traceability, enforceability, and regulatory confidence when every signature counts.
- Centralized change control management keeps every modification documented and aligned with your procedures, ensuring your quality workflows remain compliant and transparent.
Verdict:
If you want the best document management software for quality control, SimplerQMS combines compliant document control, electronic signatures, and rapid implementation, letting you get started in as little as 5-6 weeks—making it a smart choice for life sciences teams who care about audit success.
5. MasterControl
Is your document control process holding you back?
MasterControl brings powerful document management features designed for regulated environments where quality control is non-negotiable.
If you’re facing issues with compliance or struggling to track document changes, you know how critical it is to have true version control, auditability, and secure approvals built right into your workflow.
Your quality challenges deserve a purpose-built solution.
Here’s how MasterControl can turn things around for you. Their document control software has all the essentials to manage, route, and approve quality documents, with automated tracking every step of the way.
With features like automated document versioning, secure electronic signatures, and end-to-end audit trails, you get robust support for regulatory compliance. I love how the platform’s tamper-proof record of every document action comes in handy during audits or regulatory inspections, taking the stress out of preparing for compliance reviews.
Plus, MasterControl’s electronic signature capability is fully compliant with 21 CFR Part 11—so your approvals carry full regulatory weight every time. When you combine this with automated approval routing and granular access control, your team reduces errors, stays on top of tasks, and keeps your business inspection-ready all year.
MasterControl ties compliance directly into daily quality processes.
Key features:
- End-to-end document control with version management to ensure only latest, approved files are in use, reducing compliance risk and boosting traceability for every revision and approval.
- Automated, compliant electronic signatures and secure workflows safeguard approvals, helping your team meet GxP and 21 CFR Part 11 requirements directly from the platform.
- Detailed, tamper-proof audit trails for every document—track who did what and when, making regulatory inspections and internal audits faster and less stressful.
Verdict:
MasterControl stands out as the best document management software for quality control, especially for highly regulated environments. With a documented 17-month ROI and secure audit trails, you’ll achieve compliance and peace of mind faster, whether you’re prepping for FDA, ISO, or GxP audits.
6. ISOtracker
How do you keep every quality document audit-ready?
ISOtracker’s document management module lets you control document approval, track revisions, and manage change requests all in one place. You get an audit trail that actually works.
This means you never have to scramble to find the right version before an inspection, risk missing compliance updates, or worry about documentation falling through the cracks. ISOtracker’s granular control builds confidence for your next compliance check.
Let’s take a closer look at how it delivers.
With ISOtracker, you don’t just control documents — you confidently prepare for every audit and compliance deadline. Automated reminders prompt your team for reviews, approvals, and even training tasks, so nothing important gets missed.
This ensures the right people always see the latest version. You save time and always know your compliance position.
Additionally, the built-in audit management tool goes far beyond storage. It lets me schedule, assign, and analyze internal and external audits in one place. Combined, these tools empower your team to achieve audit readiness and drive real quality improvements.
Don’t let documentation slow you down.
Key features:
- Robust document control with review and approval workflows so your team never loses track of crucial changes and keeps all vital compliance documentation up to date for regulators or customers.
- Automatic reminders for reviews, approvals, and training deadlines keep everyone in the loop and eliminate the risk of missed compliance steps, supporting continuous improvement and staff accountability.
- Comprehensive audit management for internal and external audits to plan, assign, run, and analyze audits directly within the system, ensuring nothing is overlooked during quality control cycles.
Verdict:
ISOtracker is the best document management software for quality control if you want real control over compliance, instant audit readiness, and a record of 91% user satisfaction. Its modular platform makes it especially effective for small and midsize businesses.
7. QT9 QMS
How do you keep documents compliant and audit-ready?
If you’re responsible for ensuring every quality document is up-to-date and securely approved, QT9 QMS answers a lot of headaches right out of the gate with built-in document control and electronic signatures.
It tackles the chaos of outdated files by delivering a single source for updated, approved documentation that everyone trusts—critical for audits and day-to-day compliance.
You want something that just works.
QT9 QMS gives your team real control over quality documentation. You can automate document review and approval, route revisions for secure electronic signature, and guarantee only the latest version is used across your business.
Here’s how it makes your process smoother: Document control features let you set review cycles, monitor version history, and instantly recall prior revisions during audits. No more lost time chasing the latest SOP—every change is logged for full traceability.
Plus, the powerful audit management capability helps you schedule audits, track findings, and implement corrective actions in one place, all while maintaining perpetual readiness. It’s everything you need to ease compliance burdens and simplify busy audits.
The result is total confidence in your compliance.
Key features:
- Centralized document lifecycle management with version control so your team always works from the most current, approved procedures—crucial for passing audits and reducing compliance risks.
- Secure electronic signatures for regulatory approval that dramatically speeds up foot-dragging sign-offs while maintaining defensible, audit-ready documentation for every critical process.
- Built-in audit management for full audit traceability, scheduling, and corrective actions, giving you end-to-end visibility and making it easy to demonstrate compliance on demand.
Verdict:
QT9 QMS is the best document management software for quality control if you want complete document control, built-in signatures, and effortless audit prep. Its integrated modules and all-in-one dashboard help you stay audit-ready and consistent, making compliance less stressful and far more reliable.
8. Paradigm 3
Are outdated documents risking your ISO compliance?
With Paradigm 3, you’re covered by automated review schedules, precise document versioning, and online approvals—tools built for rigorous quality control needs.
If you’re worried about audit trails or managing revisions, Paradigm 3 creates a single source of truth for every document so you never have to second-guess your compliance status.
Let’s look at why this matters for you.
Paradigm 3 sets your mind at ease by handling version control for all your essential quality documents, tracking every change down to the smallest update.
Here’s how: you get an automatic audit trail and real-time notifications whenever reviews are due, so you’re never left scrambling. I love that you can handle editing and approvals online in one workflow, because this keeps processes flowing—no lost paperwork, no bottlenecks with missing signatures.
Additionally, the system’s electronic approval workflows make it easier to collaborate across QA and compliance teams, reducing delays that can hold up product releases or audit preparations.
All in all, Paradigm 3 takes the guesswork out of document management.
Key features:
- Advanced version control and audit trail tracking so your team always knows which documents are current, and you’re prepared for any compliance audit or traceability request.
- Automated review scheduling and reminders that keep your quality documentation fresh and help you avoid expired procedures tripping up production or certifications.
- Built-in electronic review and approval workflows which allow editing, comments, and sign offs within the platform—no paper, emails, or manual chases required.
Verdict:
Paradigm 3 is a smart pick if you want the best document management software for quality control. Its automated review schedules and deep audit trails give you clarity and confidence for ISO or regulatory audits, making compliance and streamlined operations genuinely achievable.
9. AssurX
Maintaining compliance can feel like a constant struggle.
AssurX takes the pressure off with robust document lifecycle management, automated workflows, and integrated audit and training capabilities tailored for regulated environments.
This means you no longer have to worry about outdated procedures sneaking into your process. Staff always work from up-to-date, approved documents, directly supporting your goal to prevent quality issues and regulatory missteps.
Let’s look at how this works in practice.
AssurX’s document lifecycle management makes it easy to stay on top of critical quality records. You can automate the full journey—from document creation and review to approval, distribution, and archival—so everyone on your team is working from the same page, every time.
Here’s how it helps you go further: Automated workflows digitize and streamline document routing and approval, freeing your team from manual tasks and ensuring quality controls are consistently applied without bottlenecks. If you’re in a highly regulated industry, I think you’ll appreciate the peace of mind here.
Plus, their audit and training management links staff competency directly to current documentation, giving you proof that employees have seen and trained on updated procedures. This holistic approach supports your overall quality goals by closing the training loop.
The result is more confidence in your compliance.
Key features:
- Complete document lifecycle control for compliance: Manages every stage from drafting to archival so only approved, up-to-date documents are accessible for regulated processes.
- Automated workflows to enforce quality procedures: Digitizes routing and approvals to speed up responses and eliminate manual errors or missed steps during quality control processes.
- Integrated audit and training management system: Ties employee training to specific documents and audit findings, giving you evidence of staff competence and regulatory adherence.
Verdict:
For enterprise-level regulated industries, AssurX is a great document management software for quality control. Document lifecycle management, automated workflows, and audit-linked training deliver the rigorous control and oversight your business needs to pass audits and ensure compliance every time.
10. Orcanos
Worried about document errors risking your compliance?
Orcanos takes the headaches out of document management with powerful automated control, built-in change tracking, and electronic signatures designed for regulated industries.
When you’re dealing with high-stakes environments, even a small documentation misstep can lead to compliance gaps, audit failures, or lost product approvals.
You don’t have to accept those risks.
Orcanos helps you lock down quality control by automating every step—from document creation to approval and revision tracking.
Here’s how: you get automated document routing, version control, and traceable electronic signatures that are fully 21 CFR Part 11 and Annex 11 compliant. That means you can prove every change and approval, no matter how complex your workflow. If you’re in the medical device or life science space, this is critical for smooth audits and risk reduction.
Plus, Orcanos takes the pain out of change management. You can automatically route modifications for review and approval, while your team stays informed without endless email threads or spreadsheet checklists. The result is end-to-end control over your quality processes, so you can focus on product innovation with full confidence.
Every step supports your compliance needs.
Key features:
- Automated document control with built-in revision management ensures every change gets tracked and keeps your documentation audit-ready at all times.
- 21 CFR Part 11/Annex 11 compliant electronic signatures let your team validate, approve, and track documents with confidence, supporting regulatory audits and traceability.
- Integrated change management workflows automate document updates so no modification goes unapproved, maintaining quality across your entire lifecycle.
Verdict:
Orcanos is a great fit if you’re seeking the best document management software for quality control, especially in regulated industries. Designed for medical device manufacturers, it slashes paperwork, reduces audit risks, and delivers real-world compliance results. Book a demo to see if it’s right for you.
11. PSC Software
Need reliable document control for compliance audits?
PSC Software’s robust document control ensures every quality record in your process is reviewed, approved, and traceable from creation to archiving.
By keeping your documentation aligned with regulatory requirements, it helps your team minimize compliance risks and simplify inspections when auditors come calling or standards change.
Here’s how you can get even more out of it.
PSC Software is purpose-built to simplify quality control challenges, especially if you’re in life sciences or another highly regulated field.
You can count on structured document management, electronic signatures compliant with 21 CFR Part 11, and full audit trails—all working together for your quality team. With audit-ready digital approvals and secure document changes, your company can keep up with FDA and GxP regulations without the anxiety.
Another great strength is the detailed audit trail. It records every document activity, so whether you’re preparing for a regulatory inspection or troubleshooting discrepancies, you always have a transparent, chronological history to refer to. Plus, integrating compliant electronic signatures protects your data’s integrity while making daily approval workflows much more efficient.
These controls really help you keep quality and compliance in check.
Key features:
- Centralized document control with audit-ready tracking: Securely manages your quality documents as they evolve, so your records are always up-to-date, reviewed, and compliant with current processes.
- 21 CFR Part 11 compliant e-signatures: Lets you and your team sign and approve documents electronically, with full traceability, to meet regulatory demands in FDA-regulated environments.
- Comprehensive audit trails for every document action: Offers a transparent record of edits, access, and approvals, making audits smoother and demonstrating strict adherence to GxP guidelines.
Verdict:
PSC Software is an excellent document management software for quality control if your company’s priority is regulatory compliance. Its FDA and GxP focus, electronic signatures, and in-depth audit trails make it ideal for life sciences teams that face strict audit demands.
12. M-Files
Looking for a better way to control your documents?
M-Files lets your team organize everything based on what a file is, not where it’s saved, making quality-related files easy to locate right when you need them.
If you’ve ever wasted way too much time hunting for the latest SOP or inspection form, you know how disruptive it is to keeping processes compliant. With custom metadata and powerful version history tracking, you can be confident everyone is using the latest, approved document at all times.
That’s why M-Files stands out for quality management.
M-Files tackles your biggest compliance headaches head-on by centralizing, securing, and auto-organizing all your quality documentation.
Here’s how: every quality record is metadata-driven, so finding what you need is instant—even if it’s stored in a shared drive, email, or local folder. The platform’s built-in version control protects data integrity for audits and allows you to roll back with a click if needed. Automated workflows help you manage reviews, approvals, and document categorization, so nothing slips through the cracks.
Additionally, M-Files replaces chaotic manual processes. Approvals, trainings, or escalation steps are handled in the platform, avoiding common bottlenecks for quality teams. The result is clear, reliable documentation—every single time.
Choose M-Files if you want compliance made simple.
Key features:
- Metadata-driven document search and organization so your team quickly finds critical quality files based on what they contain—not where they’re stored.
- Automatic version control and detailed audit trails that ensure the latest document is always used and every change is instantly traceable for full compliance.
- Automated workflows for reviews and approvals that remove bottlenecks and manual follow-ups, ensuring quality documents are always reviewed, approved, and up to date.
Verdict:
M-Files is an excellent document management software for quality control thanks to its metadata-driven search, automated workflows, and version control. You’ll save hours tracking documents and breeze through audits. Over 9,000 customers trust M-Files for better compliance and document traceability.
Conclusion
Lost in a maze of paperwork?
Choosing the right document management software for quality control is tough, especially when every option promises similar features and your team’s compliance is on the line.
According to McKinsey, organizations that establish systematic estimating processes experience 45% fewer bid errors and a 31% boost in project profitability (45% fewer bid errors and 31% improvement). That means getting control of your documents isn’t just about passing audits—it’s about impacting your bottom line.
Here’s what I recommend after reviewing everything.
FileCenter is my top pick because it solves disorganization and compliance headaches fast—giving your team instant access to every version, audit trail, and quality record you need.
If you want the best document management software for quality control, FileCenter’s automated filing and robust version control truly keep you audit-ready. Quality managers I’ve talked to regularly report cutting QC prep time by up to 80%.
You should start a free trial of FileCenter to see this for yourself.
Enjoy faster audits and full compliance peace of mind.
