Product: PAS-X Track & Trace. Older public names: Werum PAS-X Track & Trace, and, in the 21 October 2014 release, "PAS-X Track & Trace Serialization Aggregation." The 4 March 2025 release names the current version PAS-X Track & Trace V3. (Körber releases new cloud-native PAS-X Track & Trace; Factsheet: Werum PAS-X Track & Trace; Octapharma adds Track & Trace solution to Werum’s PAS-X) Vendor: Körber, Business Area Pharma. Werum IT Solutions GmbH, Lüneburg, issued the 2014 release as part of Medipak Systems, Körber's pharma systems business area. (Octapharma adds Track & Trace solution to Werum’s PAS-X) Category: Pharmaceutical packaging serialization and aggregation software, positioned by Körber as a level 3 site manager between packaging lines and enterprise or repository systems. Not PAS-X MES. Verification date: 2026-10-04 (UTC). Scope: Public sources only. Covers the track-and-trace product, not PAS-X MES.

1. Overview

PAS-X Track & Trace is Körber's level 3 serialization and aggregation site manager: it sits between packaging-line controllers and ERP, MES, and serial-number repositories, and V3 (March 2025) runs on-premise, in the customer's cloud, or as Körber-managed SaaS. It is adjacent because it handles serialization and aggregation, not batch execution, which Körber sells separately as PAS-X MES, and it is sold to pharmaceutical and biotech manufacturers that must serialize for market-specific anti-counterfeiting rules.

The factsheet calls it line-controller-independent serialization and aggregation for pharmaceutical anti-counterfeiting requirements. The 2025 release calls V3 a vendor-agnostic site manager between site systems and enterprise systems. The track-and-trace hub calls it a level 3 platform that brings packaging lines, ERP, and compliance systems together. (Factsheet: Werum PAS-X Track & Trace; Körber releases new cloud-native PAS-X Track & Trace; Track & trace)

The software requests or generates serial numbers, aggregates units and hierarchies, reconciles used and unused numbers, and exchanges data with ERP, MES, and serial-number repositories. Neither the factsheet image nor the 2025 release describes an electronic batch record. An undated MedicalExpo listing of the older Werum text adds heterogeneous and contract-manufacturing sites. (Factsheet image: Werum PAS-X Track & Trace Serialization…; Körber releases new cloud-native PAS-X Track & Trace; PAS-X Track & Trace on MedicalExpo)

Boundaries:

• Not PAS-X MES. V3 integrates with an MES. The same release's boilerplate names the PAS-X MES Suite as the MES and PAS-X Savvy as the analytics suite. The factsheet image says Track & Trace can later extend to the PAS-X Packaging Solution or the full PAS-X MES. (Körber releases new cloud-native PAS-X Track & Trace; Factsheet image: Werum PAS-X Track & Trace Serialization…)
• Not the packaging electronic batch record or Line Optimizer. The packaging page lists those in separate columns. (Packaging and serialization)
• Not STEPLogic Trace. The hub credits STEPLogic Trace, not PAS-X Track & Trace, with repository integration, a decade of use, and DSCSA help since 2013. (Track & trace)

2. Company and product identity

Point	Fact	Source
Name in 2014	"PAS-X Track & Trace Serialization Aggregation," added to Werum's PAS-X at a named site.	(Octapharma adds Track & Trace solution to Werum’s PAS-X)
Publisher in 2014	Werum IT Solutions GmbH, Wulf-Werum-Str. 3, 21337 Lüneburg, part of Körber's Medipak Systems.	(Octapharma adds Track & Trace solution to Werum’s PAS-X)
2015 positioning	Independent of equipment-vendor multi-line managers; a database of serialization data; a start that can grow into the packaging solution or the MES.	(Werum IT Solutions advances standardized Track & Trace…)
Name on the factsheet	Werum PAS-X Track & Trace, subtitle Serialization Aggregation, "full-scale site manager."	(Factsheet: Werum PAS-X Track & Trace)
Current version	4 March 2025, Lüneburg: PAS-X Track & Trace V3, "cloud-native" in the product owner's words.	(Körber releases new cloud-native PAS-X Track & Trace)
Legal rename to Körber Pharma Software	Not documented in this product's sources. The 2014 boilerplate stops at Werum inside Medipak / Körber.	(Octapharma adds Track & Trace solution to Werum’s PAS-X)
Legacy URL	koerber-pharma.com/.../werum-pas-x-track-trace now serves the mixed track-and-trace hub.	(Track & trace hub served at the former Werum PAS-X Track…)

STEPLogic Trace is a separate product on the same hub. (Körber releases new cloud-native PAS-X Track & Trace; Factsheet: Werum PAS-X Track & Trace; Track & trace)

3. Regulatory context the vendor claims

• GS1, Russia, China, FDA, EMA. The V3 release says companies must comply with GS1 standards, Russian crypto codes, Chinese NMPA, FDA, EMA, "and more," and that V3 addresses those challenges. It names neither DSCSA nor the EU Falsified Medicines Directive. (Körber releases new cloud-native PAS-X Track & Trace)
• 21 CFR Part 11. The packaging page says one application handles coding requirements including GS1 and 21 CFR Part 11 "for any global market." Vendor claim; no FDA assessment. (Packaging and serialization)
• EPCIS. The undated factsheet image lists "GS1, China, crypto codes" and "standards like EPCIS" for centralized repositories. No DSCSA or EU FMD. (Factsheet image: Werum PAS-X Track & Trace Serialization…)
• China in 2014. One announced market at Octapharma (section 9). (Octapharma adds Track & Trace solution to Werum’s PAS-X)
• DSCSA, EU FMD, "GS1-certified," "since 2013." These sit on the hub with the page introduction and STEPLogic Trace, not in a PAS-X Track & Trace sentence. (Track & trace)
• FDA records. An FDA warning-letter and Form 483 search on 4 Oct 2026 found none naming the product. (FDA warning letters (search negative for PAS-X Track &…)

Körber publishes no Computer Software Assurance package, Part 11 assessment, or IQ/OQ/PQ for Track & Trace. (Körber releases new cloud-native PAS-X Track & Trace; Packaging and serialization)

4. Capabilities

Status key: current page is a sentence naming PAS-X Track & Trace on the 2025 release or the packaging page. Factsheet image is the undated image on the current factsheet URL. 2015 wire is Werum's 2015 text, not repeated in 2025.

Capability	Status	Fact	Source
Serialization and aggregation	Current page	Line-controller-independent, for anti-counterfeiting. Table focus: "global serialization and aggregation compliance."	(Factsheet: Werum PAS-X Track & Trace; Packaging and serialization)
Site manager	2025 release	Vendor-agnostic site manager and harmonization layer.	(Körber releases new cloud-native PAS-X Track & Trace; Track & trace; Packaging and serialization)
Serial numbers	Factsheet image	Request from external systems or generate, including randomization.	(Factsheet image: Werum PAS-X Track & Trace Serialization…)
Create, discard, aggregate, disaggregate	Factsheet image	Manual packaging dialogs for units and hierarchies. "Commissioning" is not on the image.	(Factsheet image: Werum PAS-X Track & Trace Serialization…)
Reconciliation	Factsheet image	Recording and reconciliation of used and unused serial numbers.	(Factsheet image: Werum PAS-X Track & Trace Serialization…)
Repository connectivity	Factsheet image	Centralized track-and-trace repositories, "standards like EPCIS."	(Factsheet image: Werum PAS-X Track & Trace Serialization…)
Standalone database	2015 wire	A database so "a connection to a global external repository is not required." The same release says it integrates a global repository.	(Werum IT Solutions advances standardized Track & Trace…)
Repackaging and rework	2015 wire	Serialization-tree management "such as repackaging and rework."	(Werum IT Solutions advances standardized Track & Trace…)
Multi-vendor line layout	Factsheet image	Modular packaging line layout, including multi-vendor setups.	(Factsheet image: Werum PAS-X Track & Trace Serialization…)
CMO and country configuration	Factsheet image; MedicalExpo	CMO requirements as a gateway to customer repositories. MedicalExpo: heterogeneous environments, especially CMOs, different level-2 systems, country- and customer-specific requirements.	(Factsheet image: Werum PAS-X Track & Trace Serialization…; PAS-X Track & Trace on MedicalExpo)
GMP user administration	Factsheet image	"GMP-compliant user management including rights & roles."	(Factsheet image: Werum PAS-X Track & Trace Serialization…)
Named line-controller adapters	2015 wire only	OCS, Antares Vision, Laetus, Optel Vision, Seidenader, Systech, Uhlmann. The 2025 release says "any vendor" without names.	(Werum IT Solutions advances standardized Track & Trace…; Körber releases new cloud-native PAS-X Track & Trace)
EBR, master batch record, weigh and dispense	Not this product	Absent from the Track & Trace pages. The packaging page's EBR column is separate.	(Packaging and serialization)
60% / 50% / nine months / 80% / 98%	Not Track & Trace	These figures sit under the combined "PAS-X MES Packaging & Serialization" heading, outside the Track & Trace section.	(Packaging and serialization)

5. Architecture and deployment

V3 offers automatic scaling, optimized deployment, centralized operation, and a cloud-based design that runs on-premise, in the customer's cloud, or as Körber-managed SaaS. Körber says it keeps the system current and that its validation approach reduces revalidation effort, with no percentage. (Körber releases new cloud-native PAS-X Track & Trace)

The hub and MedicalExpo call it level 3. The packaging table gives integration levels L4 (supply chain) and L2 (packaging lines). These are vendor labels, not an ISA-95 conformance test. (Track & trace; Packaging and serialization; PAS-X Track & Trace on MedicalExpo)

The 2015 release says the product "comprises a database" of serialization data. The factsheet image matches: request numbers externally or generate them. Neither names the database. (Werum IT Solutions advances standardized Track & Trace…; Factsheet image: Werum PAS-X Track & Trace Serialization…)

Not published: database brand, tenant isolation, data residency, backup RPO/RTO, supported browsers, security white paper, or any version other than V3. (Körber releases new cloud-native PAS-X Track & Trace; Factsheet image: Werum PAS-X Track & Trace Serialization…; Werum IT Solutions advances standardized Track & Trace…)

6. Integrations

Kind	Fact	Weight
MES, ERP, lines, repositories	V3: standardized, configurable interfaces to packaging lines, MES, ERP, and serial-number repositories "from any vendor." Packaging page: ERP, MES, and packaging lines in one layer.	Vendor claim. No message catalog. (Körber releases new cloud-native PAS-X Track & Trace; Packaging and serialization)
MES order and stock	2014, Octapharma Vienna: interfaced to existing PAS-X, exchanging order and stock data with the MES.	One announced project. (Octapharma adds Track & Trace solution to Werum’s PAS-X)
EPCIS	Factsheet image: "standards like EPCIS." The hub's EPCIS sentence does not name PAS-X.	Example standard, not an implementation guide. (Factsheet image: Werum PAS-X Track & Trace Serialization…; Track & trace)
Line controllers	2015 list in section 4.	Not republished in 2025. (Werum IT Solutions advances standardized Track & Trace…)
Open-SCS	2015: Jürgen Laskowski says Werum takes part in the Open-SCS working group, an OPC Foundation partner, to build an open standard for packaging-serialization data exchange. Körber's current "Membership Open-SCS Working Group" page names Traxeed, not PAS-X Track & Trace.	Current membership of this product: not documented. (Werum IT Solutions advances standardized Track & Trace…; Membership Open-SCS Working Group)
Growth path	Factsheet and 2015 release: extends to the PAS-X Packaging Solution or PAS-X MES.	A commercial path, not modules inside Track & Trace. (Factsheet image: Werum PAS-X Track & Trace Serialization…; Werum IT Solutions advances standardized Track & Trace…)

7. Pricing and commercial model

Price: quote-only. The V3 release, packaging page, factsheet, and hub give no license amount. The packaging page and hub end in "Get in touch." (PAS-X Track & Trace pages inspected for a price)

• V3 runs on-premise, in the customer's cloud, or as Körber-managed SaaS, to fit "any company's business strategy." No license metric is published. (Körber releases new cloud-native PAS-X Track & Trace)
• The release promises lower total cost of ownership with no figure. René Reuter's quote repeats reduced TCO and lifecycle management. (Körber releases new cloud-native PAS-X Track & Trace)
• The packaging page's Track & Trace section claims infrastructure and update costs fall by up to 90 percent, with "near-zero" downtime, and no baseline. (Packaging and serialization)
• The factsheet sells the product as a starting point to extend later. (Factsheet image: Werum PAS-X Track & Trace Serialization…)

Public procurement. EU TED, USAspending, and UK Contracts Finder searches on 4 Oct 2026 found no award naming PAS-X Track & Trace. The one Körber Pharma award on USAspending is contract 75N90024C00029, "KORBER PHARMA PAS-X MAS SUITE," USD 955,560.40: an MES award, not a Track & Trace price. "KORBER SUPPLY CHAIN" awards are WMS or ADCS maintenance. SAM.gov was not searched. (TED; USAspending; Contracts Finder)

Questions a buyer should ask

1. License metric: site, line, serial volume, module, or installation? Is the "starting point" priced alone?
2. On-prem, customer cloud, or Körber-managed SaaS, and who validates after an update?
3. Which repository and EPCIS messages are standard and which are project work?
4. Is the 2015 line-controller list still supported, or only the 2025 "any vendor" interfaces?
5. What does "fully qualified out of the box" include, and what must the customer still qualify?
6. How is Track & Trace priced if the site also buys PAS-X MES or the packaging EBR?
7. Are DSCSA and EU FMD workflows in scope? The PAS-X-specific pages do not name them. (Körber releases new cloud-native PAS-X Track & Trace; Packaging and serialization; Factsheet image: Werum PAS-X Track & Trace Serialization…; Track & trace)
8. What about data residency, retention of the serialization database, and audit-trail export? The pages do not say.

8. Implementation and validation support

The 2025 release says implementation is quick, qualification requirements are reduced, integration is configurable, and the standard product is "fully qualified out-of-the-box." Continuous support keeps the system current, and the validation approach reduces revalidation effort. The release gives no protocol, GAMP 5 category, day count, or rate card. (Körber releases new cloud-native PAS-X Track & Trace)

In 2014 Octapharma required "a flexible and stringently validated system" for marking, identifying, and tracking. That is a customer requirement, not a validation package. (Octapharma adds Track & Trace solution to Werum’s PAS-X)

Körber publishes no validation protocol for PAS-X Track & Trace. Its GAMP 5 statement covers the MES implementation, not this product. (Körber releases new cloud-native PAS-X Track & Trace)

9. Customer evidence

Account	What is public	Limit
Octapharma, Vienna	21 October 2014 Werum release, also on Automation.com: PAS-X Track & Trace Serialization Aggregation added to existing PAS-X; first step is packaging for the Chinese market; authority serials loaded and used data reported back; order and stock data exchanged with the MES; further lines for other countries "intended."	Announcement in the future tense. No later public result. (Octapharma adds Track & Trace solution to Werum’s PAS-X; Octapharma adds Track & Trace software at pharma plant)

Healthcare Packaging reprinted the same release. (Octapharma adds Track & Trace software at pharma plant)

Octapharma is the only named Track & Trace customer. Körber's MES case studies (Cipla, Novo Nordisk, Bayer, SteriPack, and others) describe PAS-X MES. (Customer-name search for PAS-X Track & Trace)

10. Competitive and third-party context

• No independent evaluation, analyst quadrant, or paid market study of PAS-X Track & Trace is public. The V3 boilerplate's "world's leading" line refers to the PAS-X MES Suite. (Körber releases new cloud-native PAS-X Track & Trace)
• STEPLogic Trace's "award-winning" line belongs to a different product. (Track & trace)
• The factsheet image is the fullest function list and is undated. Körber still publishes it. (Factsheet image: Werum PAS-X Track & Trace Serialization…)

11. Changes and renames

• 2014-10-21: Octapharma Vienna announcement. (Octapharma adds Track & Trace solution to Werum’s PAS-X)
• 2015-11-11: line-controller adapters, Open-SCS, standalone serialization database. (Werum IT Solutions advances standardized Track & Trace…)
• 2025-03-04: PAS-X Track & Trace V3, cloud-native, three deployment models. (Körber releases new cloud-native PAS-X Track & Trace)
• 2026: the legacy product URL serves the mixed hub. (Track & trace hub served at the former Werum PAS-X Track…; Track & trace)

The 2025 release discontinues nothing and does not say V3 replaces PAS-X MES. (Körber releases new cloud-native PAS-X Track & Trace)

12. Source library

Full URL list: ../sources/korber-pas-x-track-and-trace-sources.md.

Claim-level records: ../evidence/korber-pas-x-track-and-trace.evidence.jsonl.

Primary pages:

• https://www.koerber.com/en/about-us/news-and-press/new-cloud-native-pas-x-track-trace
• https://www.koerber.com/en/solutions/software-and-ai/life-sciences-mes/digital-manufacturing/packaging-and-serialization
• https://www.koerber.com/en/insights-and-events/resources/pas-x-track-trace-factsheet
• https://www.koerber.com/en/solutions/software-and-ai/track-and-trace
• https://www.firmenpresse.de/pressrelease345471/octapharma-adds-track-trace-solution-to-werum-s-pas-x.html
• https://www.firmenpresse.de/pressrelease433666/werum-it-solutions-advances-standardized-track-trace-solutions-for-packaging-serialization-in-the-pharmaceutical-industry.html