SOP Management
By STRATESYS TECHNOLOGY SOLUTIONS, SL
SOP Management leverages OpenText and SAP to offer a modular solution that covers the full SOP lifecycle, from the creation to employee training, allowing the QA department a 360º vision of the process for any GMP compliant corporation.
Efficient and compliant Standard Operating Procedure (SOP) management is essential for highly regulated industries to maintain the highest level of quality in every facet of their operations, while at the same time reducing costs and maintaining margins.
Stratesys SOP Management solution is based on 3 modules:
- Core SOP Module: is the central pilar of the solution where the Creation, Revision, Approval, Publishing and Distribution, Review and Archiving of the SOPs is executed.
- Training Module: integrates with SAP HR module and manages the employee skill definition, training execution and work roles, jointly with the Employee Folder and the Skills Certificate lifecycle. -
- Production Module: integrates with SAP production modules for the production guide generation, publishing and post execution management.
Stratesys SOP Management solution enables an organization to:
- Comply with market regulations (i.e: FDA)
- Optimize productivity
- Reduce operation costs
- Ensure quality of production
Details
SOP Management solution allows for:
- Seamless compliance with GxP and GMP practices
- Simplification of the SOP management process
- Automation of the mandatory review and approval milestones
- Content storage in a controlled and secure platform
- Security and content access management based on standard business roles
- Complete audit trail of all the SOP lifecycle
This solution:
- Ensures compliance
- Enhances efficiency reducing cost per SOP
- Boosts productivity
- Reduces IT TCO