Improve
with Connected Manufacturing
Implement, operate, and continually improve Siemens Opcenter (MES, APS, IIoT) with
Connected Manufacturing—roadmaps, integrations, managed ops, and measurable
outcomes.
Our Approach
How We Implement and Scale Manufacturing Solutions
You don’t need another tool—you need outcomes. This page is the hub for how Connected Manufacturing implements, operates, and improves Siemens Opcenter across MES, APS, Industrial IoT, and Conversational AI. We start with a road map, stand up integrations, harden hosting, and run Ops with 24×7 reliability. Then we use data and change management to lock in gains and expand value. Why this approach works: manufacturers that combine disciplined execution with data-driven improvement scale faster and sustain results (Deloitte, 2025); (McKinsey, 2025). Standards like ISA95 ensure the stack lines up from enterprise to control, while ISO/IEC 27001 and NIST guidance keep environments secure and resilient (ISA, 2025); (ISO, 2022); (NIST, 2020).
Our Services
Understanding how we Can Help
- Our services from strategy to managed operations
- A pragmatic implementation road map (discovery → pilot → roll-out → optimize)
- Knowledge topics tied to each service, with 1-sentence synopses
- Clear recommendation and FAQs to start quickly
Offering the Different Services Manufacturers Need
Strategy & Advisory
Outcomes: a prioritized roadmap with payback windows, architecture options, and risk controls.
Deliverables: value model & ROI case, ISA95 aligned architecture review, data readiness scorecard, transformation KPIs, change plan.
Implementation & Integration
Deliverables: Opcenter config, equipment/test connectors, ERP/QMS/PLM interfaces, data migration, role-based work instructions.
Hosting & Managed Cloud
Outcomes: secure, performant environments with tested backup/DR and RTO/RPO.
Deliverables: SaaS/private cloud setup, SRE runbooks, monitoring/alerts, backups, DR exercises.
Staff Augmentation
Outcomes: surge capacity without slipping governance or validation.
Deliverables: solution architects, MES/APS engineers, PMs, SMEs embedded in your team.
Support & Maintenance
Outcomes: predictable uptime and upgrades.
Deliverables: SLAs, break/fix, patching, version upgrades, regression tests.
Managed Services / Operations
Outcomes: 24×7 monitoring, incident response, capacity management, scheduled improvements.
Deliverables: SLOs/KPIs, incident & change cadence, quarterly value reviews.
Training & Enablement
Deliverables: role-based training, admin certification paths, SOPs, knowledge base.
Validation & Compliance
Outcomes: rightsized CSV/validation and 21 CFR Part 11 alignment.
Deliverables: validation plan & traceability matrix, test protocols, electronic signatures/audit trails approach, audit preparation.
Data & Analytics
Outcomes: OEE/quality/energy visibility and yield-oriented troubleshooting.
Deliverables: modeled data layer, KPI definitions, dashboards & alerting, loss-tree and root-cause routines.
Change Management & PMO
Outcomes: adoption, behavior change, and realized benefits.
Deliverables: stakeholder mapping, communications plan, training waves, benefits tracking, governance ((Prosci, 2023)).
Defining an Implementation Roadmap
Discovery
(Weeks 0–2)
Objectives, constraints, validation scope, data inventory, ISA95 mapping; define pilot slice.
Design & Prototype
(Weeks 3–6)
Configure MES/APS/IIoT baseline, interface contracts, migration plan, security & backup design (ISO-aligned).
Pilot
(Weeks 7–12)
Connect equipment and sources, enforce eDHR/eBR, finite-capacity scheduling, OEE base-lining, change enablement.
Rollout
(Week 13+)
Expand cells/lines/sites; formalize governance, training, and quarterly value reviews.
Optimize
(Ongoing)
Tune rules & heuristics, improve loss trees, automate packets/reports, and iterate on KPIs ((FernandezViagas et al., 2022); (Deloitte, 2025)).
From Theory to Practice
Improve Knowledge Topic
Explore a curated library of essential manufacturing topics. Each entry includes a concise 200-word overview for quick learning and an in-depth 800-word article for deeper insights into standards, systems, and best practices.
Roadmaps that pay back
Build a 90-day plan that sequences MES, APS, and IIoT by value and readiness (ties to ROI and risk).
Read More
Opcenter integration patterns
Proven interface contracts for SAP/QMS/PLM and equipment/test systems—no swivel chair.
Read More
Finite-capacity scheduling, explained
How APS models constraints (skills, changeovers, cleanrooms, reentrant flows) to improve promise dates.
Read More
Data migration that doesn’t bite
Master data, genealogy, and history import strategies that avoid downtime and bad WIP.
Read More
Hosting, backups & DR
Design RTO/RPO, test restores, and run-books that satisfy IT/security and auditors.
Read More
24×7 managed operations
What great monitoring catches before operators do; incident & change cadences that reduce risk.
Read More
Validation & 21 CFR Part 11
Practical, risk-based CSV and electronic signatures/audit trails that pass inspections.
Read More
OEE & loss-tree fundamentals
Standardize availability, performance, and quality so improvements stick across plants.
Read More
Why this approach works
Discovery
objectives, constraints, validation scope, data inventory, ISA95 mapping; define pilot slice.
Design & Prototype
configure MES/APS/IIoT baseline, interface contracts, migration plan, security & backup design (ISOaligned).
Pilot
connect equipment and sources, enforce eDHR/eBR, finitecapacity scheduling, OEE baselining, change enablement.
Rollout
expand cells/lines/sites; formalize governance, training, and quarterly value reviews.
Optimize
tune rules & heuristics, improve loss trees, automate packets/reports, and iterate on KPIs (FernandezViagas et al., 2022); (Deloitte, 2025).
From Theory to Practice
Improve Knowledge Topic
Explore a curated library of essential manufacturing topics. Each entry includes a concise 200-word overview for quick learning and an in-depth 800-word article for deeper insights into standards, systems, and best practices.
Roadmaps that pay back
Build a 90-day plan that sequences MES, APS, and IIoT by value and readiness (ties to ROI and risk).
Read More
Opcenter integration patterns
Proven interface contracts for SAP/QMS/PLM and equipment/test systems—no swivel chair.
Read More
Finite-capacity scheduling, explained
How APS models constraints (skills, changeovers, cleanrooms, reentrant flows) to improve promise dates.
Read More
Data migration that doesn’t bite
Master data, genealogy, and history import strategies that avoid downtime and bad WIP.
Read More
Hosting, backups & DR
Design RTO/RPO, test restores, and run-books that satisfy IT/security and auditors.
Read More
24×7 managed operations
What great monitoring catches before operators do; incident & change cadences that reduce risk.
Read More
Validation & 21 CFR Part 11
Practical, risk-based CSV and electronic signatures/audit trails that pass inspections.
Read More
OEE & loss-tree fundamentals
Standardize availability, performance, and quality so improvements stick across plants.
Read More
From Theory to Practice
Improve Knowledge Topics
Explore a curated library of essential manufacturing topics. Each entry includes a concise 200-word overview for quick learning and an in-depth 800-word article for deeper insights into standards, systems, and best practices.
Roadmaps that Pay Back (Manufacturing Digital Roadmap)
Build a 90‑day plan that sequences MES, APS, and IIoT by value and readiness (ties to ROI and risk).
Opcenter Integration Patterns that Lift Yield
Proven interface contracts for SAP/QMS/PLM and equipment/test systems—no swivel‑chair
Finite-Capacity Scheduling, Explained
How APS models constraints (skills, changeovers, cleanrooms, re‑entrant flows) to improve promise dates.
Read More
Data Migration That Does Not Bite
Master data, genealogy, and history import strategies that avoid downtime and bad WIP.
Read More
Hosting, Backups, and Disaster Recovery That Keep Lines Running
Design RTO/RPO, test restores, and runbooks that satisfy IT/security and auditors.
Read More
24×7 Managed Operations for Opcenter
Design RTO/RPO, test restores, and runbooks that satisfy IT/security and auditors.
Read More
Validation and 21 CFR Part 11 Without the Drag
Validation can either slow manufacturing or make it safer and faster. The difference is scope and evidence. This article explains how to apply risk-based Computer Software Validation to Opcenter so electronic records, electronic signatures, and audit trails meet 21 CFR Part 11 requirements without turning every change into a stall. You begin by defining what is GxP-critical, then create a simple traceability matrix that ties requirements to configuration to tests to training. You implement controls for identity, signatures, time stamps, and audit trails, align security and change under ISO 27001, and rehearse backup and recovery per ISO 22301 so records remain trustworthy after incidents. For global operations, you harmonize FDA expectations with EU Annex 11 and MHRA data integrity guidance so evidence reads the same on both sides of the Atlantic. The result is faster release, fewer deviations, and simpler audits because the evidence is complete and findable. Throughout, the article references primary regulations and leading guidance such as FDA Part 11, EU Annex 11, ISPE GAMP 5 Second Edition, ISO 9001 for change control, and NIST control catalogs that keep operations resilient (FDA, 2018; European Medicines Agency, 2011; ISPE, 2022; ISO, 2015; ISO, 2022; NIST, 2020). The goal is confidence and speed at the same time, not a binder on a shelf.
OEE and Loss-Tree Fundamentals
Frequently Asked Questions
- Q1. How do you decide where to start?
We start where the constraint is loudest—compliance risk → MES/eDHR; due‑date pain → APS; visibility gaps → IIoT/OEE—framed by a 90‑day plan and a thin‑slice pilot ((Deloitte, 2025)). - Q2. Do we have to go cloud‑first?
No. We support on‑prem, cloud, and hybrid; the choice depends on latency, data residency, and your validation context. We design RTO/RPO and controls up front (ISO/NIST). - Q3. What about integrations and equipment?
We use ISA‑95 to map entities and events; then connect ERP/QMS/PLM, historians, PLC/SCADA, testers, and vision systems. Standardized contracts reduce testing effort ((ISA, 2025)). - Q4. How do you handle validation and Part 11?
Risk‑based CSV aligned to 21 CFR Part 11 guidance, with traceability, test protocols, and electronic signatures/audit trails ((FDA, 2003; 2023)). - Q5. What keeps benefits from fading after go‑live?
Quarterly value reviews, scheduling rule tuning, loss‑tree refreshes, and active change management (coaching, communications, training) ((McKinsey, 2025); (Prosci, 2023)).
References
Deloitte. (2025, May 1). 2025 Smart Manufacturing and Operations Survey. https://www.deloitte.com/us/en/insights/industry/manufacturing/2025-smart-manufacturing-survey.html
This report is a current benchmark on smart‑manufacturing adoption, budgets, and scaling obstacles. It analyzes results from 600 U.S. manufacturing leaders, covering investment focus, data readiness, talent, cybersecurity, and value realization. Two points matter for the Improve pillar: investment is climbing while skills/data remain gating, and quick‑win pilots that scale outperform big‑bang transformations.
Fernandez‑Viagas, V., Ruiz, R., & Mula, J. (2022). Exploring the benefits of scheduling with advanced and real‑time information integration in Industry 4.0: A computational study. Computers & Industrial Engineering, 171, 108424. https://doi.org/10.1016/j.cie.2022.108424
This paper provides empirical evidence for constraint‑aware, information‑rich scheduling. Through computational experiments, it compares static plans to schedules that incorporate fresh shop‑floor signals under variability. The lessons for continual improvement are that live data and explicit constraint modeling improve service levels and reduce firefighting.
Food and Drug Administration (FDA). (2003). Guidance for Industry—Part 11, Electronic Records; Electronic Signatures—Scope and Application. https://www.fda.gov/media/75414/download
This guidance underpins MES/eDHR programs where electronic records and signatures must withstand audits. It clarifies the scope of 21 CFR Part 11 and expectations for risk‑based validation, audit trails, and security. Practically, it argues for aligning validation to risk and ensuring integrity/traceability of regulated e‑records.
International Organization for Standardization (ISO). (2022). ISO/IEC 27001:2022—Information security management systems—Requirements. https://www.iso.org/standard/27001
This standard defines the ISMS requirements relevant to hosting/managed cloud and on‑prem MoM environments. It details risk‑based controls and continuous‑improvement practices, aligning with ISO 27002. Adopting 27001 supports defensible governance for backups/DR, access, and monitoring in run‑state operations.
International Society of Automation (ISA). (2025). ANSI/ISA‑95.00.01‑2025 (IEC 62264‑1 Mod): Enterprise‑Control System Integration—Part 1: Models and Terminology. https://www.isa.org/products/ansi-isa-95-00-01-2025-iec-62264-1-mod-enterprise
ISA‑95 supplies the layered model and vocabulary that connect enterprise systems with manufacturing operations. Part 1 defines objects and information exchanges used to map products, materials, equipment, personnel, and events across Levels 3–4. Using this common language reduces integration rework and accelerates delivery across MES/APS/IIoT.
McKinsey & Company. (2025, March 11). Powering productivity: Operations insights for 2025. https://www.mckinsey.com/capabilities/operations/our-insights/powering-productivity-operations-insights-for-2025
This research summarizes where operations leaders are capturing value and why some transformations sustain results. It synthesizes survey and case evidence on workflow redesign, governance, and capability building across industries. For Improve, two implications stand out: leadership accountability and ongoing skills development drive durable outcomes, and live data shortens the path from detection to decision.
National Institute of Standards and Technology (NIST). (2010; updated 2021). SP 800‑34 Rev.1—Contingency Planning Guide for Federal Information Systems. https://csrc.nist.gov/pubs/sp/800/34/r1/upd1/final
This guide structures backup/DR planning and testing—the backbone of reliable run‑state operations. It explains contingency planning lifecycles, roles, and exercises, and ties them to business impact. Two practical takeaways are to document and test recoverability and to set RTO/RPO aligned to the criticality of each system.
National Institute of Standards and Technology (NIST). (2020). SP 800‑53 Rev.5—Security and Privacy Controls for Information Systems and Organizations. https://nvlpubs.nist.gov/nistpubs/SpecialPublications/NIST.SP.800-53r5.pdf
This catalog provides tailorable security and privacy controls for enterprise and OT‑adjacent systems that support MoM. It lays out control families for governance, access, monitoring, and resilience and maps to risk‑management frameworks. Implementing a right‑sized 800‑53 baseline makes security part of day‑to‑day operations, not a bolt‑on.
Pinedo, M. L. (2022). Scheduling: Theory, Algorithms, and Systems (6th ed.). Springer. https://link.springer.com/book/10.1007/978-3-031-05921-6
Pinedo’s text is the standard foundation for APS and constraint‑aware scheduling used in modern MoM stacks. It spans single‑machine through job‑shop and re‑entrant flows, with heuristics, algorithms, and system design trade‑offs. The enduring lessons are that constraint‑aware methods beat naive rules under variability and that implementation detail and data quality matter as much as the algorithms.
Prosci. (2023, May 26). Best Practices in Change Management—Research highlights. https://www.prosci.com/blog/change-management-best-practices
Prosci’s multi‑year research links strong change practices to project success rates. The summary highlights adoption enablers, roles, and the value of integrating change management with project management. For Improve, it reinforces that behavior change, communications, and sponsorship are the multipliers that keep benefits from fading after go‑live.