Define observable impact values during registration to create a clearer, more descriptive technical record.
Deviation and Incident Management
Capture the event. Control the outcome
Manage deviations and incidents within a compliant, controlled workflow. Spectrum’s quality management system delivers integrated process optimization from deviation registration through investigation, CAPA, and change control where required. It captures grades and impacts, drives structured actions, and ensures every event progresses through a defined path from initial registration to final closure.
Graded Registration and Impact Capture
Start every case with the right context
At registration, users capture product details along with grades and observed impacts, then receive a system-generated deviation/incident number based on the organization’s configured numbering scheme. This gives each case a consistent identity and structured context from the point of entry.
Initial Findings and Controlled Triage
Investigate what needs investigation
After registration, users record the initial findings and determine whether a formal investigation is necessary. If it is, the case moves into the Investigation and CAPA workflow. If it is not, the deviation or incident can proceed directly to closure with the outcome fully documented.
Investigation, CAPA and Risk-Based Action Management
Move from root cause to controlled action
When deeper evaluation is required, Spectrum QMS enables controlled investigation initiation, responsible user assignment, CAPA definition, action finalization, and risk consideration. Actions are assigned to selected user groups, completed by authorized personnel with remarks, and closed with complete investigation details, along with change control initiation if required.
More reasons to switch with Spectrum
Deviation Impact Setup
Packaging Diagnostics
Capture packaging, testing condition, and orientation at registration to support a complete stability evaluation.
Category and Sub-Category
Classify events by category and sub-category for consistent tracking, cleaner reporting, and better QMS analysis.
Formal Deviation / Incident Closure
End each case with documented result and closure details, while retaining the ability to review completed events by status.
Deviation / Incident Inquiry
Generate a complete inquiry view showing status, category, and user responses so teams can review case history and current standing from one place.
Traceable Compliance History
Operate in a 21 CFR Part 11 compliant environment where changes require documented reasons and workflow actions are maintained as part of a defensible quality record.
Email Intimation for Investigation and Action Assignment
Keep follow-up moving by assigning investigations and actions to group users with email intimation at the stages explicitly supported by the manual.
FAQ
Frequently Asked Questions
You can configure the registration-number scheme during setup, preview the format, and then let the Spectrum total quality management system generate a unique deviation/incident ID automatically for each new record.
The registration process includes product details, batch details, grades, impacts, process details, and other relevant event information, all tied to the generated deviation/incident number for further processing.
Yes, after documenting the initial findings, users can decide whether an investigation is required. If it is not required, the deviation or incident can be closed with documented results and closure details.
If investigation is required, the case moves into Investigation & CAPA, where users define investigation results, create corrective and preventive actions, measure risk for each action, assign actions to group users, complete them through authorized users, and then close the investigation.
Yes, Spectrum’s quality management system is 21 CFR Part 11 compliant, with authenticated access, password-expiry handling, and documented reasons for edits.
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
Sofcom provided excellent support and training during implementation.
Sofcom has done a great job with providing us the support and training while implementing their Human Capital Management solution in our organization. We are thankful to their team and hopeful to continue our business partnership with them.
