Using A.P. Lyon Procedures in an eQMS: Import, Adapt and Validate
Short answer: yes. Every A.P. Lyon procedure, manual, list and form is an editable Microsoft Word or Excel file. You can run them as a paper-based system, or import them into any electronic quality management system (eQMS) that manages Office documents. This guide explains how to move the documents into an eQMS without losing the controls they describe, and which steps remain your responsibility.
A.P. Lyon supplies documentation, not software. We do not certify compatibility with any named eQMS platform, and the templates are not "validated" or "Part 11 compliant" on their own. Those outcomes depend on how your organization configures, validates and uses its system.
Before you import
Decide the system of record. Agree which documents and records will live in the eQMS and which, if any, stay on paper during the transition.
Map roles. Match the job titles in the procedures (for example Quality Assurance, Regulatory Affairs, Engineering) to the roles and approval groups in your system.
Keep the numbering. Set up document types for SOP, FORM, LIST and the quality manual so the cross-references inside the procedures still resolve.
Start from the content list. Use the package content list (LIST 0001 or LIST 0001-C) as your import checklist.
Step-by-step: from download to released documents
Adapt the content first. Add your company name, scope, products and responsibilities before import, so the first approved revision in the system is your own.
Replace paper wording. Change wet-signature blocks, "sign and date" instructions and references to binders or logbooks so they describe how your system applies electronic signatures and keeps records.
Choose how each form will live. Keep a form as a controlled template attached to its procedure, or rebuild it as an electronic form or workflow, for example for CAPA, complaints, nonconformances, change orders and training. A rebuilt form should capture the same fields and approvals as the template.
Align procedures and workflows. Make each procedure's review, approval and change-control steps match the workflow states in the system. Where the system drives a step, the procedure should say so. The Document Control Procedure is usually the first one to align.
Validate the eQMS software. See the next section. Do this before the system holds released documents or quality records.
Train and release. Route the adapted documents through the system's approval workflow, train users on both the procedures and the software, and withdraw superseded paper copies.
Validating the software is your responsibility
ISO 13485:2016 clause 4.1.6 requires documented procedures for validating computer software used in the quality management system, before initial use and after changes, proportionate to the risk of that use.
FDA's QMSR (21 CFR Part 820), effective February 2, 2026, incorporates ISO 13485:2016 by reference, so the same expectation applies to U.S. medical device manufacturers. FDA's Computer Software Assurance guidance describes a risk-based approach to that assurance work.
21 CFR Part 11 applies to electronic records and electronic signatures that FDA regulations require you to keep. Confirm how your system meets it for those records. See the current text of Part 11.
Vendor validation packages help, but you still own intended-use validation. Document your intended use, the risks, the testing or other assurance you performed, and the result.
A.P. Lyon's Software Validation Procedure (Dual-Standard: SOP 7-033-C) provides a documented approach for this work. It is included in several system packages and is also sold separately.
Paper, hybrid or electronic
The same documents work in all three set-ups. Many organizations start on paper or in a shared drive with controlled templates, then move to an eQMS as they grow. Because the files stay editable, you can carry your approved revisions forward instead of starting again.
Dual-Standard (ISO 9001:2026 and ISO 13485:2016) users
The Dual-Standard documents follow the same approach. Keep the -C document numbers, and make sure the eQMS controls documented information in a way that satisfies both standards, including access, retention, change history and protection of records.
Need help?
Compare packages on the Compare QMS page, choose individual documents with Build Your QMS, or read How to Choose a Medical Device Quality Management System and Medical Device Document Control: From Approval to Record Retention. For installation support or a post-installation audit, contact A.P. Lyon. For regulatory background, see the FDA QMSR & ISO 13485 Resource Center.
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