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S-88 based Manufacturing Consulting and Support Services

Altra Systems offers expertise and support to pharmaceutical companies seeking to implement, optimize, or enhance their manufacturing processes following the ANSI/ISA-88 standard. The company's scope encompasses a range of services designed to ensure efficient, compliant, and standardized batch manufacturing operations. 

By offering a wide range of services, Altra Systems helps pharmaceutical organizations optimize their batch manufacturing processes while ensuring regulatory compliance and industry best practices.

System Assessment and Strategy:
-Evaluate the current manufacturing processes and technology infrastructure.
-Develop a strategy for implementing S-88 compliant systems that align with the client's business objectives.

Design and Development:
-Design modular process models, equipment modules, and control modules based on S-88 principles.
-Develop unit procedures, phases, and operations that reflect the client's manufacturing processes.
-Create reusable control modules and recipes for various batch operations.

Integration and Implementation:
-Provide guidance on integrating S-88 compliant systems with existing manufacturing execution systems (MES), process control systems, and enterprise systems.
-Collaborate with the client's engineering teams to implement the designed process models and control strategies.

Recipe Management System (RMS) Setup:
-Assist in the selection and implementation of an RMS that supports S-88 standards.
-Configure the RMS to manage recipes, procedures, phases, and equipment modules efficiently.

Validation and Compliance:
-Ensure that the implemented systems adhere to regulatory requirements, such as FDA guidelines for pharmaceutical manufacturing.
-Assist in the validation of the S-88 based manufacturing systems to meet quality and compliance standards.

Training and Knowledge Transfer:
-Provide training programs for operators, engineers, and maintenance personnel on S-88 principles, system operation, and troubleshooting.
-Facilitate knowledge transfer to the client's team, empowering them to manage and maintain the system effectively.

Optimization and Continuous Improvement:
-Offer expertise in process optimization, recommending ways to improve efficiency, reduce waste, and enhance product quality.
-Support ongoing system improvements, updates, and modifications to adapt to changing requirements.

Project Management and Support:
-Provide project management services to ensure timely and successful implementation of S-88 based systems.
-Offer post-implementation support for troubleshooting, maintenance, and updates.

Documentation and Reporting:
-Create comprehensive documentation, including standard operating procedures (SOPs), technical documentation, and compliance records.
-Generate reports for regulatory submissions and audits, demonstrating compliance with industry standards.

Change Management and User Adoption:
-Develop change management strategies to facilitate smooth transitions to S-88 compliant systems.
-Assist in user adoption by addressing concerns and providing training and support during the transition.