Change Management
- Ensure Consistent and Continual Improvement
Change Management
Current paper based or manual change control system leaves scope for human errors, unwanted repetitions, lack traceability and many others which can drastically effect turn-around time, productivity and ultimately the product safety or quality. This scenario explains the need for Change Control Management Software.
An enterprise wide quality management solution with change control as a key component is essential to managing and controlling change for operational excellence as well as for regulatory compliance
Changes to validated procedures for production and process. RQP Change App used with integrated CAPA, Document Management, Training, etc., Change Control can be a powerful tool for continuous improvement in the organization.
Royal Quality Pillars shall simplify the initiate, review, and approval of multiple type’s assessments with well-defined workflows with a structured methodology for each change request and track it through its lifecycle from initiation through initiation to closure.. And provide comprehensive solution for change management and control across departments and functions.
Initiation
To Initiate Change Request with detailed information, such as classification (Major, Minor and Critical), area (e.g. process, equipment, or document) scope, rationale change date, associated risks, and expected impact, associated non-conformance or CAPA and relevant documents can be attached.
Auto Classification of Change shall be done based on Risk Priority Number (RPN) as per ICH Q9.
Multiple Change line Items are shall be initiated against multiple change actions.
And request is submit without any life cycle section
Review /Approval
Based on the initiator, automatically routed Change Request review/ approval for department, Quality units, and management in parallel for their assessment and approval. Initiator gets a notification upon approval.
During the review / approval, Action shall be identified such as testing requirement or impact on regulatory requirements, training, lot disposition, validation, quality, or stability is documented
Multiple users to review the document at the same time, and add their comments or feedback.
Change Action Execution
When the implanting change, lifecycle mechanism (Execution, Review, Approve and Documentation) can be set to ensure the change are review with compliance.
Change Closure
Post change assessment can again be routed for approval by quality management units for final closure. Enables a closed loop change management by assigning verification tasks to evaluate the outcome of the change on affected products or processes.
Effectiveness Verification
Schedule action shall be generated for verification of Effectiveness of Change action.
Tracking
Ensures responsiveness as the change Request appears on the “My Assignment” list of the assigned person upon approval with a due date, a failure to act by due date leads to escalation.
Reports and Dash Boards
Graphical executive dashboards and flexible reports and provide statistics and data on Real time reports. by type, status, audit history, in-process documents, approval cycle times, usage summaries, and average review times. Demonstrable analytics and reports, real-time tracking of the document management.
E-mail Alerts
Notify concerned stakeholders during the flow and after publishing, changing, or updating a document
Search
The app provides you with powerful capabilities to search for assignments based on attributes, content, author, and other parameters. The app also has the ability to save previous searches, and allow users to mark documents as favourites, which enables quick access to a set of documents.
Compliance
21 CFR Part 11, GAMP 5 and GxP Compliance
Review of existing business and technology policies and processes
Identification of infrastructure components including network diagram study
Gap Analysis vis-à-vis ISO Part 11, Annexure 11 MHLW & Understanding of Information Security Requirements. Generate the remediation roadmap and implementation plan
Validation
Computer System Validation Services
Validation Team is Involve the V- Modal Validation from URS User Requirement Specification to Performance Qualification.
Documentation
Provide the Following Documentation
Master validation Plan
IQ/OQ/PQ plan for individual systems
Individual system documentation (FRS, SRS, SDRS, Design Document etc.)
Test plans and Test cases
Individual systems Test results for individual systems Final validation reports for individual systems System traceability matrix
Services
Gap Assessment of systems before an FDA inspection
Remediation support wherever necessary
Training the required employees with certification
Audit/Certification Support Services
Change Management Advantages
Advantage #1 – Widely applicability to all types of changes from minor typographical corrections to critical Facility modifications.
Advantage #2 – Based on the change classification to set the best Workflow for thorough evaluation and effective implementation.
Advantage #3- Automated routing for Corporate and regulatory assessment based upon criticality of change proposed.
Advantage #4- Capabilities to integrate and establish closed-looping with other Quality Systems.
Advantage #5- Metrics Reports or Trends that are exclusively analytical and visually eye catching.
Advantage #6 – Improved timeliness
Advantage #7 – No more emails
Advantage #8 – Increased security and control
Advantage #9 – More reliable backups
Advantage #10 – Lower document management and archiving costs
Advantage #11 – Better knowledge management and search
Advantage #12 – Built-in regulatory compliance
Advantage #13 – More consistent content
Advantage #14-Automatic notifications and alerts to simplify document distribution
Advantage #15-Supports electronic signatures on document with accurate time-stamped along with audit trails.
Advantage #16-Scalable system with robust integration capabilities to meet the organization’s requirements
Advantage #17- Any Time Readiness (ATR) for Audit .