Adjust audit schedule statuses with the required details and reasons, so plans stay flexible while records remain controlled and traceable.
Audit Management | Spectrum QMS
Stay audit-ready with structure, control, and consistency
Spectrum’s quality management software provides a 21 CFR Part 11 compliant framework to schedule audits electronically, standardize checklist-driven execution, and maintain control over who can perform each step. From audit initiation through authorized completion, every activity follows a defined and traceable workflow.
Standardized Checklist Execution
Build consistency into every audit
Create specific checklists, define the required questions, and apply user-defined result codes so every audit is performed against a structured standard rather than inconsistent free-text judgment.
Authority-Based Audit Workflow
Control who does what at every stage
Spectrum follows a disciplined workflow from Initiate → Assignment → Checklist Response → Authorized Completion. Only assigned users can respond to the checklist, and only authorized users can complete the audit, reinforcing accountability throughout the process
Automated Next-Date Scheduling
Keep your audit program moving without manual follow-up
Once an audit is completed and authorized, Spectrum’s QMS automatically generates the next schedule date, helping teams maintain continuity and reduce the risk of missed audit cycles.
More reasons to switch with Spectrum
Dynamic Schedule Status
User-Defined Result Codes
Define the result codes that fit your quality system and use them consistently across audits for more objective and standardized reporting.
Audit Inquiry and Reporting
Switch between schedule-level and detailed views to review planned and completed audits, along with related records, in one place.
Traceable Audit History
Maintain audit activity in a controlled, 21 CFR Part 11–compliant environment with fully traceable changes and status updates.
FAQ
Frequently Asked Questions
Once an audit is officially completed and authorized, Spectrum’s quality management system automatically calculates and generates the next audit date based on your pre-defined recurrence logic.
Yes, Spectrum allows users to record audit findings against the audit record, including observations, nonconformities, remarks, severity, and responsible departments. This helps teams track issues clearly and move them toward review, action, and closure.
Auditors use standardized result codes. A "Critical" finding can be flagged instantly, and because the system is a closed-loop quality management system, it can trigger immediate follow-up actions.
Absolutely, Spectrum’s QMS uses a strict authority-based mechanism. Only assigned users can respond to a checklist, and all edits are captured in an unalterable audit trail.
Yes, authorized users can change a schedule’s status, provided they enter the relevant details and reasons for the change, maintaining a compliant history.
Yes, if an audit finding requires a formal change, Spectrum can link it with the Change Request module so the required process, document, method, or system change follows a controlled approval workflow.
Yes, Spectrum supports electronic signature-based authorization for key audit steps, including audit completion and closure. This ensures that critical decisions are verified by authorized users with traceable user, date, time, and status details.
Yes, Spectrum can structure different audit types such as internal audits, external audits, vendor audits, regulatory audits, and departmental audits. Each audit type can be managed with its own checklist, schedule, category, and authorization flow.
Helping Businesses of all Sizes for 32+ Years
Leading Fortune 500 companies trust our enterprise solutions for HR, payroll and quality
Testimonials
What They Say About Us
A reliable partner for smarter laboratory management.
Working with Sofcom has been a rewarding experience. Spectrum has proven to be a valuable solution for managing laboratory operations, helping us improve data analysis and support better decision-making.
I look forward to Sofcom’s continued innovation and the positive impact their solutions will have on the pharmaceutical industry.
