DACHS is, and will always strive to be a competent, cost competitive, innovative, dependable, and profitable near-sourcing application development and service provider firm, specializing in document management systems for companies with global footprints.
To build long-term partnerships with our clients for mutual and sustainable growth.
Reliability, competency, mutual respect, integrity, innovation, customer focus, flexibility and responsiveness.
Since the company’s inception, DACHS continuously expands its number of specialists with exceptionally low turnover, and high employee satisfaction. Currently our team consists of 70 professionals, many of them having PhD or Master’s degrees. About one-third of our team are experienced software developers or project managers, and other team members are experienced in providing professional technical support services.
Our experts work both in Switzerland and Hungary, providing innovative and complex solutions for high-volume data and content management in the pharmaceutical industry around the world. We have three offices in Europe:
- Headquarters of the company and Consultancy Services are based in Basel, Switzerland
- Development and Service Management are based in Budapest, Hungary
- Development and Support are located in Miskolc, Hungary
DACHS is a Near-sourcing IT company with expertise in document management systems and publishing for pharmaceutical companies. DACHS understands the criticality of timely submissions to various health authorities, and the associated demand for strong technical and process skills, to maintain the integrity of content management systems. The majority of DACHS engineers are EMC certified, and all supporters are trained and certified with ITIL Foundation. Our Service and Support managers have advanced ITIL certificates (i.e.: Service, Transition, Management and Operations). This enables us to have a common understanding of industry standard processes and terminologies. Our project managers are PMP or PRINCE2 certified professionals.
DACHS engineers and support professionals are top university graduates, where DACHS maintains internship and fellowship programs, which became a reliable source for talent supply.
Our key expertise includes, but not limited to providing integrated application developments and user support services for document management systems, based on Documentum technology. Our focus predominantly covers the health care industry (pharmaceuticals, biotech, and CRO), where regulatory requirements (GxP and 21 CFR Part 11) are constantly and consistently applied.
We are committed to high quality standards in all service areas guided by the certifications issued by SGS:
- Internal quality assurance system (ISO 9001:2008)
- Internal information security system (IEC/ISO 27001:2005)
- IT service management system (ISO/IEC 20000)
- CIBA Geigy
- Documentum applications user support services
- Documentum applications lifecycle support
- Applications customization
- Custom applications development
- Project management implementing document management related products and their interfaces
- Extended history in providing application development and support services to Novartis
- Extensive GxP and 21 CFR Part 11 experience – meeting client’s stringent quality requirements
- FDA submission process experience (supporting WebTrader, AS2 Gateway)
- EMA submission process experience (supporting AS2 Gateway)
- CESP submission process experience
- TMF Reference Model experience
- Certified EMC Documentum professionals
- Vendor trained MS-SharePoint professionals
- Experienced Java, SQL, .Net developers
- ITIL, PMP, PRINCE2 certified professionals
- Over 20 years of experience in application development
- Over 10 years of experience in providing support services for mission critical applications
- RSS (Regulatory Solutions Suite) (TRS)
- Insight for Rendering
- EFT Server Enterprise
- Rosetta Phoenix
- Lorenz eValidator
- Global Submit Validate, EURS Validator
- CSC Toolbox
- Java, HTML, SQL, DQL, Office templates/macros, Tomcat, VBA
- OpenTxt Document
- J2EE (Java / JSP / XML / HTML)
- Open-Source Libraries / Frameworks
- BC4J (Business Components for Java)
- Microsoft .NET C#, VB
- Eclipse / JDeveloper (Oracle)
- Visual Studio .Net
- Enterprise Architect (Sparx-Systems)
- Oracle/BEA WebLogic
- MS SQL
- JUnit – Java Unit Regression Testing Framework
DACHS offers two products: DEX and CompEX. To achieve seamless implementation and hassle-free maintenance of Documentum products and their upgrades, they are proven by a long history of usage:
DEX – Documentum EXchange tool
CompEX – compares and corrects differences of docbase objects between two docbases even in validated environments by generating executable scripts
Tracker Tool – follow up and quality control of TMF documents
The eTRAC application provides for the clinical team details about the available final Trial Master File (TMF) documents stored in the document management System and assists users in reconciling key information for inclusion in Clinical Study Report (CSR) appendices and Financial Disclosure reporting. Users will use this application to validate documents’ readiness for publication, submission and audit based on the specific criteria. The tool provides a summary report of the verifications and validations or non-validation of the documents.
TMF ToC – visualization of documents, stored in a document management system, in a different (virtual) structure
TMF ToC is a WebEdi component which allows retrieval and display of Trial Master File (TMF) documents of project/indication, compound, trial, country and site levels, according to the TMF Table Of Contents (TMF TOCs) templates (Country, Site, Headquarter and Single Center TMF TOC) and the Ready to Initiate (RIS) checklist template.
For auditors and Health Authorities inspectors, TMF ToC is a window on the TMF documents re-organized according to the TMF Master List, which has a structure similar to the TMF Reference Model, in order to facilitate navigation, access to and review of the TMF documents, as per applicable regulatory requirements.
Regulatory labelling solution – collaboration of documents related to medicament-labelling
This application is a central, worldwide repository developed to provide global alignment and harmonization of Labeling processes across regions and therapeutic areas. Regulatory labelling solution facilitates prompt communication with HA on legal questions, or to GLC/PSB requests (Global Labeling Committee/ Portfolio Stewardship Board) by providing the Labeling status of a product in many countries today or for a specific period in time, or historically (years ago).
Application provides a user interface to store released, submitted, and HA approved labelling documents from HQ and CPOs in a Labelling Cabinet of the Repository. Allows the publishers to create Core Labelling Package (CLP) directly by copying the document management application links of the CLP documents which are provided by the Global Labelling Managers in a Tracking Sheet. Key is that users can easily and quickly find the documents, view or export them, and include links to documents in application to E-Mails. The Application supports dispatch of documents to CPOs by sending E-Mails. Furthermore Regulatory labelling solution provides a user interface to store communication between HQ, CPOs and Health Authorities regarding label related HA correspondence in a Labelling Cabinet of the Repository.
eTMF– separation and upload of scanned PDF documents
The eTMF3 (electronic Trial Master File) system is used to import scanned copies of original paper documents and electronic final documents directly to the appropriate folder and level (Country, Site or Study) of the TMF Reference Model
eTMF4 is a web-based application that provides fast TMF document upload to OpenText Documentum D2 with metadata consolidation/indexing functionality with help of a user-friendly and state of art user interface.
PDF Separator – separation of scanned PDF
PDF Separator checks the uploaded PDF documents for electronically stamped separators and black separator pages and splits them into individual files accordingly.
FlexReport – create and make available of easily configurable queries for user groups
FlexReport extends the functionality of all WebEdi applications with advanced search capabilities which serve all users including those who do not have account in any WebEdi systems. These external accounts can be configured in FlexReport.