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What life sciences organizations should do before investing in a quality management solution
Solution Consultant - Presales, AODocs · Apr 21, 2023 · Updated Oct 6, 2026
What do all Life Sciences organizations, be they startups, established companies, institutions, or research centers have in common? Regulations.
Life sciences organizations should identify FDA requirements applicable to their products, activities and records. Responsibilities differ by regulatory scope; quality managers need evidence that relevant processes and controls operate as intended.
For finished-device manufacturers within FDA QMSR scope, 21 CFR Part 820 incorporates ISO 13485:2016 by reference from February 2, 2026. Determine applicable requirements and exemptions before configuring a Quality Management System (QMS). ISO certification is separate: FDA does not require an ISO 13485 certificate, and a certificate does not exempt a manufacturer from FDA inspection.
But we’re getting ahead of ourselves. Before you invest in a QMS, you should do a little homework.
It starts with cultivating and maintaining a quality culture, literally from day one. It’s helpful to build some “muscle memory” so that compliance becomes a core part of your company’s DNA and your workflow process. Figure out where you have bottlenecks or points of failure, and address those. This could mean training, it could mean applying enforcement penalties. The goal is to come up with a repeatable process that makes it easier to stay compliant.
A QMS can support documented quality processes and evidence. Leadership, training and everyday decisions remain part of quality culture; software does not automate those responsibilities.
While many types of businesses in highly regulated industries could benefit from a QMS solution, in Life Sciences these requirements should factor into selecting one:
- Which applicable FDA requirements can the configured system support, and what evidence demonstrates that support?
- Can we retrieve required records and demonstrate how configured controls operate?
- Is it cloud-hosted so that remote teams can collaborate from any location?
- Which security controls apply to our data, users and deployment, and how will we verify them?
- Which electronic records and signatures fall within Part 11 scope, and which system and procedural controls are needed?
Depending on your other business systems, check whether needed integrations are available and how they are configured. If you use Google Workspace, evaluate a QMS Platform that integrates with Google Drive.
Lastly, you should ensure that whatever QMS for Life Sciences platform you choose can scale and grow as your company grows.
There’s more to all of this, of course, so click here if you have any questions, or would like to see a demo of AODocs for Life Sciences.
Frequently asked questions
What should life sciences teams define before choosing QMS software?
Life sciences teams should define their products, jurisdictions, regulated records and intended software use before choosing a QMS. Turn that scope into testable requirements for document control, access, training, signatures and evidence retrieval. A general claim of compliance does not establish that a particular configuration meets the organization’s obligations.
What are the requirements for a QMS for medical devices?
For manufacturers within FDA QMSR scope, ISO 13485:2016 is incorporated by reference into 21 CFR Part 820 from February 2, 2026. Applicability and exemptions must be assessed for the device and manufacturer. An ISO certificate is a separate matter; certification does not replace compliance with the FDA requirements that apply.
How should buyers evaluate a vendor’s Part 11 claim?
Buyers should ask which electronic records and signatures are covered, which controls require configuration and what evidence demonstrates the intended use. FDA’s Part 11 guidance links scope to records required by predicate rules and recommends a documented assessment. A feature list alone does not resolve record, procedural or validation responsibilities.
