Product: Opcenter Execution Pharma (also Opcenter EX PH, EX PH). Siemens fact sheets say it was formerly SIMATIC IT eBR (the SIMATIC IT suite electronic batch record). A partner listing on siemens.com offers migration from Elan XFP / ELAN v6.x. Neither statement makes every SIMATIC IT product this one. Vendor: Siemens. Siemens Aktiengesellschaft, Digital Industries, Nuremberg, publishes the V2405 electronic-records response. Release notes are issued as Siemens Digital Industries Software, in the Xcelerator portfolio. The 2025 Polpharma supply agreement is with Siemens Sp. z o.o. Category: Pharmaceutical manufacturing execution system (MES) for paperless execution and electronic batch records. Not an ERP, LIMS, QMS, or the plant DCS. Verification date: 2026-10-02. Scope: Public web sources only. Features of other Opcenter products (Execution Discrete, Process, Electronics, Medical Device and Diagnostics, Semiconductor, Quality, Intelligence, RD&L, APS) and goals for future releases are excluded.

Opcenter Execution Pharma is Siemens’s pharma eBR and MES, the former SIMATIC IT eBR, and its main selling point is native integration with SIMATIC PCS 7 and SIMATIC Batch. It fits pharmaceutical plants that already run Siemens automation and want master batch records, weigh and dispense, and review by exception in one system, delivered by Siemens or partners such as OYTEC and Technord.

1. Overview

Opcenter Execution Pharma is Siemens’s MES for paperless pharmaceutical production and electronic batch records. The product page describes master-batch-record-driven manufacturing, resource guidance, control of human and automated steps, a single store of batch documents, and review by exception. (Siemens product page, retrieved 2026-10-02.)

Siemens sells it to pharmaceutical manufacturers that need an electronic batch record tied to the automation layer. The campaign page talks about producing drugs and vaccines faster, with design, execute, and review “as required by FDA, CFDA and European regulatory bodies.” That is positioning, not an agency certificate. (Campaign page.)

The software designs master batch records and executes them as electronic batch records and work instructions. It guides operators, captures signatures and exceptions, and covers materials, weighing and dispensing, equipment, and packaging. It exchanges data with ERP and with SIMATIC PCS 7 / SIMATIC Batch.

Related products:

• Opcenter Execution Discrete, Process, Electronics, Medical Device and Diagnostics, and Semiconductor are separate MES products in the same family. (Execution family.)
• Opcenter APS and Opcenter Laboratory are separate products this one integrates with.
• SIMATIC PCS 7 and SIMATIC Batch are the automation products it connects to.
• Siemens’s own rename sentence is narrow: formerly SIMATIC IT eBR. The 2009 Elan (XFP) purchase is older and broader (section 2).
• The product is current. Siemens published release 2605 on 15 June 2026 and has announced no discontinuation.

2. Company and product identity

Point	What the sources say	Source
Current name	Opcenter Execution Pharma, short name Opcenter EX PH, under Products / Opcenter / Execution. Page metadata names maintainer department “DI SW PLM.”	Product page
Former name	2205 fact sheet: “formerly known as the SIMATIC IT suite electronic batch record (eBR).” The 14 April 2021 blog for 6.2.3: “formerly known as SIMATIC IT eBR.”	2205 fact sheet; 6.2.3 blog
Version numbering	Numbering moved to year and month. “Version number 2205 follows version number 6.2.4.” The fact sheet gives no calendar release date.	2205 fact sheet
Later releases	2505 (16 July 2025), 2511 (10 December 2025), 2605 (15 June 2026). “Opcenter EX PH 2025” on the campaign page is a year label, not a build number.	2505; 2511; 2605; campaign page
Elan / XFP	Pharma Manufacturing, 16 April 2009: Siemens recently bought French supplier Elan, known for the XFP MES. A Siemens speaker discusses combining SIMATIC IT and XFP. The article does not use the Opcenter name.	Pharma Manufacturing, 16 Apr 2009
XFP today	OYTEC, a partner selling on siemens.com, migrates “XFP/ELAN (from v6.x) or Opcenter Execution Pharma” to the latest version, including on-premise to cloud. Partner copy, not Siemens history.	OYTEC migration listing
Compliance booklet	ERES response for V2405, edition 10/2024, order number A5E54074635-AA, © Siemens 2024. Address: Siemens Aktiengesellschaft, Digital Industries, Postfach 48 48, 90026 Nürnberg. This is the author of the response, not a seller.	ERES V2405 PDF
Fact-sheet brand	Last page of the 2205 fact sheet (84624-D3 5/22 H): “Siemens Digital Industries Software,” siemens.com/software, “© 2022 Siemens.” No legal entity suffix.	2205 fact sheet
Contracting company on a sale	The 18 February 2025 press release: Zakłady Farmaceutyczne Polpharma S.A. signed with Siemens Sp. z o.o. for delivery and implementation, including licenses. This names the contracting company for that deal only.	Polpharma press
Software license	EULA v9.0 (April 2026), headed “Siemens Digital Industries Software.” Parties: “the Siemens entity named on the Order (‘Siemens’ or ‘SISW’)” and the customer. It does not name this product.	EULA v9.0 PDF, linked from the EULA page
MOM terms	Manufacturing Operations Management Supplemental Terms v2.5 (January 2026) amend the SISW agreement for offerings coded MOM on the order. They do not name this product; “Simatic IT Software” appears only about credits.	MOM terms PDF
Portfolio	Release notes place it in Siemens Xcelerator, which the 2605 note calls a business platform of software, hardware, and services.	2605 blog

No page names one Siemens legal entity as the worldwide seller. The EULA leaves the entity to the order. No U.S. company (such as a Siemens Industry Software Inc.) is named as seller.

3. Pharma and biotech relevance

The product and campaign pages are written for pharmaceutical manufacturing: electronic batch records, master batch records, GMP, and FDA. The 6.2.3 and 2605 notes say “life sciences/pharma” and “life sciences industries.” Siemens publishes no biologics-only or cell-and-gene datasheet.

Regulatory wording, all from Siemens or partners:

• Product page: batch manufacturing “fully compliant with the U.S. Food and Drug Administration (FDA) and good manufacturing practice (GMP) regulations.”
• Campaign page: an electronic batch record “as required by FDA, CFDA and European regulatory bodies.” CFDA is Siemens’s word. It is not a Chinese marketing authorization.
• ERES booklet, V2405 only: Siemens evaluated the product against 21 CFR Part 11 (1997) and EU GMP Annex 11 (2011) and says “Siemens Opcenter Execution Pharma version V2405 fully meets the functional requirements for the use of electronic records and electronic signatures,” together with organizational measures the regulated user must put in place. The regulated user validates the application. This is a supplier self-assessment, not an FDA or EMA certificate. It covers V2405 and “adjacent applications inseparable from the product,” and excludes standalone applications that can be interfaced. It takes ISPE GAMP 5 into account but publishes no GAMP category.

4. Capabilities

Functions named on the campaign page (a catalog, not measured performance):

Function	What the page says	What it does not say
Master batch records	Graphical workflows, text editor, pre-built work elements, parameter management	No object model or schema
Electronic batch record	Guided instructions, tactile environment, real-time control, deviation management, release by exception	No sample batch-record PDF
Material management	Goods receipt and sampling, QC, picking, tracking and tracing, goods issue and shipping	Not a WMS
Weighing and dispense	Scale management and calibration check, 16 predefined weighing methods, tolerance, potency and density calculations, check-in/out	“16” is a vendor count
Equipment management	Classes and properties; fixed, mobile, single-use or reusable; lifecycle configuration; equipment logbook
Packaging	Line instructions, in-process quality control, replenishment, concordance and reconciliation	Not serialization
Automation integration	OPC and OPC UA client, MES task list in the HMI, native integration with SIMATIC PCS 7 and SIMATIC Batch
Enterprise integration	Standard connectors to business and manufacturing systems, integration with Opcenter APS and Opcenter Laboratory	APS and Laboratory are separate products
Design / execute / review	Process reuse with “no IT skills required”; guided acquisition; single point of review and review by exception

Release notes add dated vendor claims:

• 2205 (follows 6.2.4): end-to-end process-instruction translation; HMI task-list filtering for SIMATIC WinCC panels by work order, work center, and wildcards; more open weighing and dispensing.
• 2505 (16 July 2025): alerts in an Operator Cockpit (adaptable via low-code); real-time task-list refresh; annex upload API; cyclic operations with pause/resume and reason codes; equipment logbook export to PDF/A and Oracle performance notes; e-signature on PI-item links; weighing user exits; RUP/ROP loop counters from the triggering batch; Ansible playbooks for PostgreSQL installation; example Oracle playbooks in the DAID package. “Integrated OEE KPIs” appears only in the benefits list, with no described screen.
• 2511 (10 December 2025): web execution of existing rich-client operating text without redesign; tags for text, numeric, time, checkbox, multi-value, e-signature, equipment, automation, and scripts; conditional sections; value correction with traceability; annex upload, review, signature, and rejection in the cockpit; alert review and signature; process-instruction import across versions; API to upgrade a parent process instruction when a subprocess changes; install automation for API services and Mendix apps; script execution categories; Mendix 10.24 LTS.
• 2605 (15 June 2026): more web tags (list, labelling, barcode, alerts); e-signatures for forced values and tolerance deviations; Smart Operation Designer, which uses AI to turn legacy PDFs into electronic work instructions, with a copilot, templates, and BPMN import; a modular web weighing app (Manual and Net modes) that talks to balances through Mendix Workstation and runs beside the legacy rich-client weighing app for cases it does not yet cover; manufacturing declaration for lots in any status; container updates via XSI; process-instruction import by API using .cab files; core services optimized to cut Oracle CPU and I/O; an AI documentation assistant.

Review by exception appears on the product page, the campaign page, the 2205 fact sheet, and the Polpharma press (as a planned function). No public study measures release-time reduction at a named site.

5. Architecture and deployment

• A workflow engine and electronic work instructions (2205 fact sheet and later notes).
• Two clients: a rich client (PI Process / operating text) and a web Operator Cockpit. 2511 says web execution needs no client install and no redesign of existing process instructions. 2605 extends the web scope and keeps the legacy weighing client.
• Mendix is the low-code layer for web apps: Mendix 10.24 LTS (2511) and Mendix Workstation for balances (2605).
• Databases appear only in release notes, not a support matrix. 2605 describes Oracle CPU and I/O reductions in PI Service and PI Process. 2505 mentions Oracle DB support and Ansible installation of PostgreSQL, with example Oracle playbooks in DAID.
• XSI is named in 2605 only as the path for container updates.
• The campaign section “eBR in the cloud” states a goal: future releases of “our eBR Apps Suite” on cloud infrastructure and a low-code platform, to make paperless batch records “more affordable.” It is a goal, not the current default or a price.
• Polpharma’s project has a cloud-based architecture so staff can reach it from any location. That describes one implementation.
• OYTEC sells on-premise-to-cloud migration as a service. No Siemens cloud regions or Siemens-operated SaaS SKU are published.

Siemens publishes no security white paper, API reference, or supported-platform matrix.

6. Integrations

Kind	What is public	Limit
Native automation	Campaign page: native integration with SIMATIC PCS 7 and SIMATIC Batch. 6.2.3 and 2205 notes: native MES–DCS integration. Bayer story: Execution Pharma and SIMATIC Batch inside SIMATIC PCS 7, one user interface, MES workflows triggered by DCS events.	No interface specification opened
HMI	2205: MES task list filtered per SIMATIC WinCC panel. Campaign page: MES task list in the HMI; OPC and OPC UA client.	WinCC is a Siemens HMI, not this MES
ERP and other systems	Campaign page: “seamlessly integrates” MES with automation and ERP; “standard connectors”; Opcenter APS and Laboratory. 6.2.3 blog: MES, automation, and ERP integration.	No named ERP vendor, IDoc, or BAPI
Shop-floor events	2505: RUP/ROP loop counters passed to an event process instruction. 2605: XSI container updates; .cab process-instruction import.	Release notes only
Partner delivery	Technord Belgium implements and refers sales and pricing to Siemens. AG Solution describes design, engineering, deployment, and a support team, with no price. OYTEC sells migration.	Services, not product features

7. Pricing and commercial model

Price: quote-only. No list price is published. The product page and Technord’s listing say “Contact us for sales and pricing information.” The campaign page says “Get in touch.” AG Solution’s U.S. listing has no price and no contact sentence. No page has a per-user or per-site fee.

AWS Marketplace price for a different product. Opcenter Execution Discrete is listed at custom quote, “one year pricing for 20 users starting at” 88,000 US dollars. It is recorded so it is not reused as an Execution Pharma price. (AWS Marketplace, Execution Discrete.)

The commercial model:

• Software plus services. Polpharma’s release lists licenses, engineering, training, and application and post-implementation support, with no license metric.
• Partners (Technord, AG Solution, OYTEC) sell implementation separately on the Siemens marketplace, each by quote.
• Cloud appears as one project’s architecture (Polpharma), a partner migration offer (OYTEC), and a future goal (campaign page). None is a rate card.
• Release notes claim lower total cost of ownership without numbers.

Procurement records. Searches of USAspending, SAM.gov, EU TED, UK Contracts Finder, and Find a Tender on 2 Oct 2026 found no notice naming Opcenter Execution Pharma or SIMATIC IT eBR. The Polpharma release states no amount.

Questions a buyer should ask

1. License metric: site, line, named user, concurrent user, module, or installation? Is weighing priced alone?
2. Which client is quoted (rich client, web cockpit, or both), and through which release? 2511 and 2605 still describe a transition.
3. Which database (Oracle or PostgreSQL), whose Ansible or DAID package, and who runs it?
4. Is SIMATIC PCS 7, SIMATIC Batch, or WinCC in the MES price or a separate automation quote?
5. Are ERP connectors, Opcenter APS, and Opcenter Laboratory in the software price?
6. Is Polpharma-style cloud a Siemens-operated service or the customer’s cloud? Is the “future” eBR Apps Suite a SKU yet?
7. Which ERES booklet covers the version being bought? The one opened is V2405 (October 2024), not 2605.
8. Who validates (the regulated user, Siemens, or a partner such as OYTEC), and are IQ/OQ templates included?
9. What does a move from XFP/ELAN v6.x or 6.2.x cost, and is OYTEC the Siemens path or a partner path?
10. What does “review by exception” include, and which deviations still need qualified-person review?

8. Implementation and validation support

The V2405 ERES booklet is the most specific validation document. It says GMP computerized systems must be validated, that Siemens develops the product under its PLM process, and that the regulated user validates the application. It maps Part 11 and Annex 11 clauses to product behavior and procedural controls. It is not a site IQ/OQ/PQ.

OYTEC says it supplies a validation plan, IQ/OQ test-case templates, impact assessment, custom-code migration, and cutover planning, including from XFP/ELAN v6.x. “Zero impact” and “risk-free” are partner marketing.

Technord says it designs, engineers, and deploys projects. AG Solution’s U.S. English listing calls the firm “an important player in Europe” in pharma, food and beverage, green energy, bulk storage, water treatment, and waste treatment, working in long-term automation and digitalization partnerships. Its product sentence: “Siemens' Opcenter Execution Pharma is specialized software for the pharmaceutical industry. It optimizes batch management, provides real-time tracking, quality management, electronic documentation, and ensures regulatory compliance, meeting stringent pharmaceutical production standard.” “Quality management” is AG Solution’s phrase, not a Siemens QMS module. Its services sentence: “AG Solution has the team in place to design, engineer, and deploy Opcenter Execution Pharma projects including a support team for optimal usage and governance of the solution.” Benefits: “High quality delivery of Opcenter Execution Pharma projects” and “We go beyond the platform, connecting the dots and securing your environment.” Capabilities: platform and connectivity knowledge with implementation and scaling, and “Pharmaceutical process & validation expertise.” The Prerequisites heading is empty. Metadata names maintainer department DI PA. It names no Siemens legal entity, day count, or rate.

Polpharma (press, 18 February 2025) is the most concrete public project plan: agreement with Siemens Sp. z o.o.; started January 2025; completion “by 2028 at the latest”; licenses, engineering, training, and support; sites Sieradz, Starogard, Nowa Dęba, and Duchnice; phased, Sieradz first; hybrid agile and waterfall. Siemens Poland’s Marcin Płatkowski is quoted. It is a plan at signature.

The Bayer story describes a migration with no production break, old and new MES in parallel, Hypercare, and 24/7 project standby. No validation protocol is published.

Siemens publishes no Computer Software Assurance package, other Part 11 assessment, or completed site IQ/OQ/PQ.

9. Customer evidence

Account	What is public	Limit
Bayer, Bitterfeld-Wolfen	Siemens story under a 2022 path. Aspirin site opened in 1994. New system: Execution Pharma plus SIMATIC Batch in SIMATIC PCS 7, migrated during running production from paper to paperless. Dr. Andrea Heym, head of Formulation: production “at least as fast as before.” Siemens project manager Michael Berger is named.	Vendor story. No go-live date, version, or release metric
ZF Polpharma	Siemens press, 18 February 2025. Agreement to deliver and implement Execution Pharma, January 2025 to 2028, four named sites. Cloud-based architecture, electronic batch reports, release by exception as a key function. Dorota Chęć, Sieradz plant director and management-board member, is quoted.	A signed program, not an outcome. No price
AGC Pharma Chemicals, Barcelona	Pharma Focus Europe advertorial by Maria Grahm, Vice President, Vertical Management Pharma, Siemens. The site runs SIMATIC PCS 7 and SIMATIC Batch and uses Execution Pharma for electronic batch records from material receipt through dispensing, production, and batch review. Nina Mikadze, Systems and Compliance Manager, is quoted. Claims: more than 530 manual entries removed, more than 80 pieces of equipment, more than 4,000 data tags, barcoded materials, review by exception, Part 11 and Annex 11 compliance, and the first pharma company in Spain to implement the integrated Siemens solution. Labeled Issue 06; year not shown.	Advertorial. Figures not independently checked

No other named production site is public.

10. Competitive and third-party context

Nucleus Research. A Siemens blog (18 August 2026) says Siemens was a leader in Nucleus’s 2026 MES Technology Value Matrix, for the Opcenter portfolio and AI-driven insights. Portfolio leadership is not evidence of an Execution Pharma function.

Gartner. A Siemens blog (15 May 2026) discusses the 2026 Gartner Market Guide for MES in Siemens’s words. Both reports are paywalled, and no public Magic Quadrant excerpt names Execution Pharma.

Pharma Manufacturing (2009). Used only for the Elan / XFP purchase and the interview claim that XFP brought weighing and dispensing and “full EBR” into SIMATIC IT. It predates the 2605 note by sixteen years.

ISPE. Siemens cites GAMP 5 in the ERES booklet. That is a reference, not an ISPE certification.

Partner pages and trade outlets. Technord, AG Solution, and OYTEC are seller copy that confirm a services ecosystem. The AGC piece is an advertorial. No independent technical evaluation is public.

11. Changes and renames

• 2009-04-16: Pharma Manufacturing reports Siemens bought Elan, maker of XFP.
• 2021-04-14: Opcenter Execution Pharma 6.2.3, “formerly known as SIMATIC IT eBR.”
• Undated 2205 fact sheet: 2205 follows 6.2.4 under year-month numbering.
• 2024-10: ERES response for V2405, document A5E54074635-AA.
• 2025-02-18: Polpharma agreement.
• 2025-07-16: release 2505.
• 2025-12-10: release 2511.
• 2026-05-15: Siemens blog on the Gartner Market Guide.
• 2026-06-15: release 2605.
• 2026-08-18: Siemens blog on the Nucleus Value Matrix.

Siemens has announced no discontinuation. Siemens itself prints only SIMATIC IT eBR as the former name. XFP/ELAN rests on the 2009 acquisition report and OYTEC’s migration offer; the product page does not say “formerly XFP.”

Regulator records. FDA and EMA searches on 2 Oct 2026 found no record naming Opcenter Execution Pharma or SIMATIC IT eBR.

12. Source library

Full source list: sources note.

Main pages:

• Opcenter Execution Pharma product page
• Campaign page
• Execution family page
• Version 2205 fact sheet
• ERES V2405
• Release 2605
• Polpharma press
• Bayer story