Corbinsoft plans and executes Polarion 21 CFR Part 11 validation for medical device manufacturers and other FDA-regulated teams: a risk-based package showing your configuration does what you intend, with audit trails, access control and electronic signatures tested and traced.
Part 11 applies when records required by FDA regulations are created, modified, maintained, archived, retrieved or transmitted electronically, and when electronic signatures are used in place of handwritten ones. For a Polarion system that holds design inputs, risk files or test evidence, that covers most of the daily engineering work in a medical device program.
Subpart B covers electronic records and Subpart C covers electronic signatures. Read the full text on eCFR. New to ALM? Start with our Why ALM guide.
Validation for accuracy, reliability and consistent performance, the ability to discern altered records, and accurate copies in human-readable and electronic form.
Secure, computer-generated, time-stamped audit trails of actions that create, modify or delete records, kept as long as the record and leaving earlier values visible.
Access limited to authorised individuals, and authority checks on who can sign, alter a record or perform an operation.
Records protected and retrievable throughout the retention period your predicate rules require.
Signed records show the signer's printed name, date and time, and meaning. Signatures are linked to their records so they cannot be excised, copied or transferred. Each signature is unique to one person, and non-biometric signatures use two identification components, such as user ID and password.
Polarion supplies the controls. Validation shows they work as configured in your system.
Every change to a work item or LiveDoc is stored as a new revision with author and timestamp, and earlier values stay retrievable.
Signatures attach to workflow transitions on work items and documents. Signers re-authenticate, and the administrator sets whether later signings need the password alone or both user ID and password.
We configure signature roles and workflow states so each signature records who signed, when, and the meaning, such as review or approval. That information appears on screen and in PDF exports of the record.
Role-based permissions at project, document and field level. Workflow conditions restrict who can approve, sign or change a record in each state.
Baselines freeze a project or document at a point in time. Records export to PDF or Word for inspection, and backups follow your retention procedure.
Workflow conditions enforce the permitted order of steps under §11.10(f), for example blocking approval until required reviews and trace links exist.
Some Part 11 controls are procedural, such as training, signature accountability policies and the certification your organisation sends to FDA. We help you write the SOPs that cover them.
A risk-based package sized to your intended use, in which each deliverable traces to the next.
FDA's guidance on Computer Software Assurance for Production and Quality System Software describes a risk-based, critical-thinking approach: identify the intended use, decide whether a failure could foreseeably lead to a quality problem that compromises safety, and choose assurance activities to match.
For Polarion, that usually means scripted testing for signatures, audit trail and access control, and unscripted testing for lower-risk functions such as personal dashboards. Read our guide to applying Computer Software Assurance to Polarion.
Each Polarion function in scope is tied to a documented use in your quality system.
High-risk functions get scripted protocols. Lower-risk functions get unscripted testing with concise records.
Intended use, risk, what was tested, issues found, conclusion, and who tested when.
No. FDA does not validate or certify software tools. Under 21 CFR Part 820, which incorporates ISO 13485, a medical device manufacturer must validate software used in its quality management system for its intended use, and 21 CFR Part 11 applies when that software holds electronic records or electronic signatures required by FDA regulations. Polarion provides the technical controls Part 11 calls for, such as audit trails, access control and electronic signatures. The validation evidence is produced for your configuration and intended use, and Corbinsoft prepares and executes it with your quality team.
A typical package contains an intended-use and risk assessment, a validation plan, user and functional requirements, a configuration specification, IQ, OQ and PQ protocols with executed results, a traceability matrix, a validation summary report, and the change control and periodic review procedures that keep the system in a validated state.
Every upgrade needs a documented change impact assessment. We review the Siemens release notes against your validated configuration, rate each change by risk, and run regression testing in proportion: scripted tests for high-risk functions such as electronic signatures and audit trail, lighter testing elsewhere. The outcome is a validation addendum or a fuller revalidation, sized to the change.
Yes. Polarion supports electronic signatures on work items and LiveDoc documents as part of workflow transitions. Signers re-authenticate when they sign, and an administrator can set whether later signings need the password alone or both user ID and password. Your organisation remains responsible for the procedural side of Part 11, including the certification to FDA that your electronic signatures are the legally binding equivalent of handwritten signatures.
Tell us how Polarion supports your quality system, and we will outline a validation scope that fits.