Organize change requests by category and type so workflows, user authority, and review expectations align with the nature of the change.
Change Control Software
Control every change from initiation to implementation
Stop fearing the "ripple effect" of process updates. Spectrum’s change control software provides a secure, rule-based framework to evaluate and implement changes, ensuring your validated state remains intact while your business moves forward.
Structured Change Assessment and Impact Classification
Give every change the right level of control
Spectrum allows teams to configure category-based workflows using serial or parallel approvals, required sign-offs, threshold days, and reminder alerts. This ensures every change request follows a controlled approval route based on its category, risk, and procedural requirements. The module also integrates with Investigation and CAPA workflows, allowing any CAPA triggered by a change request, or any change request initiated because of an investigation or CAPA, to be correctly mapped. Once approved, specific tasks can be assigned to responsible users or departments, with due dates, completion status, and remarks for full accountability.
Configurable Workflows, CAPA Mapping and Task Management
Move every change through the right approval path
Spectrum allows teams to configure category-based workflows using serial or parallel approvals, required sign-offs, threshold days, and reminder alerts. This ensures every change request follows a controlled approval route based on its category, risk, and procedural requirements. The module also integrates with Investigation and CAPA workflows, allowing any CAPA triggered by a change request, or any change request initiated because of an investigation or CAPA, to be correctly mapped. Once approved, specific tasks can be assigned to responsible users or departments, with due dates, completion status, and remarks for full accountability.
Controlled Implementation, E-Signature and Module Integration
Record what changed, who approved it, and where it applies
After approval, authorized users can implement and close changes with recorded dates, remarks, evidence, and e-signatures. Integrated with e-DPCS, LIMS, and other Spectrum modules, every change stays mapped to affected documents, methods, specifications, processes, and related records. This creates complete traceability from change request to assessment, approval, implementation, e-signature, and final closure.
More reasons to switch with Spectrum
Change Categories and Types
Precision E-Sign Meanings
Define exactly what each electronic signature means and control which authorized users can apply that meaning in the workflow.
Automated Email Notifications
Notify assigned users when action is needed and keep stakeholders informed as requests move through approval and implementation stages.
Traceable Change History
Maintain changes in a controlled, 21 CFR Part 11 compliant environment where edits and updates are documented as part of a traceable history.
Timeline Thresholds and Reminders
Set threshold days and reminder days at the workflow level to keep reviews moving and reduce approval bottlenecks.
Change Inquiry and Reporting
Generate, preview, and print detailed change records so teams can review request details, status, and implementation information without searching across multiple screens.
FAQ
Frequently Asked Questions
Each change is classified by impact level. Your team can use that classification to apply the appropriate workflow and level of review based on internal procedures.
Yes, Spectrum’s quality management system allows you to configure category-based workflows using serial or parallel approvals, along with defined sign-offs, timelines, and authorized users.
If an authorized user rejects a request during the approval stage, that change cannot proceed to action or implementation for that specific ID.
Yes. Spectrum’s change control software includes automated email notifications to alert assigned users when action is required and to keep stakeholders informed as the workflow progresses.
Authorized users record implementation details directly in the system, including the implementation date, revision number, and relevant remarks.
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.
