Dokument wird geladen
GxP compliant solutions for your digital documentation digital life sciences digital document and quality management (Page 2 f.) • Introduction (Page 5) • Product Overview (Page 7) • Regulations (Page 8 ff.) • Controlled Documents (Page 12 ff.) • Employee Qualification (Page 16 f.) • E-Learning (Page 18 ff.) • QM-Workflows (Page 21 f.) • Process Documentation • Contract Management (Page 23 f.) • Technical Documentation (Page 25 f.) • References (Page 27 f.)
About Digital Life Sciences GmbH Digital Life Sciences GmbH was founded in April 2007 by Thilo Gukelberger, also co-founder of d.velop AG. We are a provider of digital and GxP-compliant documentation solutions and have focused on the specific requirements of the life sciences industry since our founding. Our solutions build on and ex- tends to the ECM/DMS system of d.velop AG, namely d.velop documents (formerly d.3ecm). With currently more than 13,000 installations world-wide and 3.1 million users, d.velop AG is one of the leading European providers of electronic document management and workflow systems. 2 The concepts of life sciences solutions for the Quality manage- ment of GMP-relevant processes, can be read, among others, in the "GMP compliance adviser" ( : "GMP-Berater") by the publishing house Peither. Thilo Gukelberger and other company employees are authors for the GMP Compliance Adviser and have published the following chapters, among others: • • • • • • Chapter 1.H: IT systems for the optimization of quality management processes Chapter 2.C: Training management Chapter 9.B: Regulatory requirements for computerized systems and the validation process Chapter 9.D.2: Risk management in the validation of computerized systems Chapter 9.E: Qualification and validation of computerized systems Chapter 15.G: Document management systems
2007 approx.140 … founded and thus over 15 years of experience … customers in regulated environment in the (GxP) regulated environment approx. 70 … employees Author Founder Managing Director Thilo Gukelberger 3
approx. 53,000 happy users employ our software every day Certified according to ISO 9001:2015 GAMP Industry focus: regulated environment Successfully audited by our customers Biotechnology Pharma- ceuticals Food Medical Technology Chemicals Cosmetics Laboratories … and other companies with a strong focus on quality management 4
d.velop documents (form. d.3ecm) + QMS = Comprehensive DMS and QMS Solution Solutions Our digitization solutions address, first and fore- most, document-based processes in manufacturing, production and quality management. The basis of the life sciences system is an integrated ECM/DMS system. All software solutions can be added as modular building blocks and can grow to become a complete GxP-compliant eQMS suite. The turquoise shaded modules illustrate this aspect. The ECM/DMS system can also be expanded to in- clude non-GxP applications and can be linked to your existing ERP system (e.g. SAP), thus enabling you to map almost all document-based processes in your company. Electronic Quality management Digital Personnel File Contract Management Technical Documentation Complaint Deviation Control CAPA Change Control Document Control E-Mail Archiving Employee Qualification management Scanning and Classification E-Learning Incoming Invoice Processing Audit proof archive & Structured workflows d.velop documents & many more comm. solutions Interfaces & Integrations 5
DLS eDMS | eQMS - cloud or on-premise? Both! In order to be able to offer you the ideal mode of operation for our software solutions, we are strategically aiming to give you, our customers, the choice. We want you to be able to decide for yourself which deployment method is most suitable for your needs. In addition to the typical on-premise operation, in which the eDMS | eQMS Suite is operated in your own infrastructure, we offer you the use of our suite in the cloud as an alternative, either as software as a service (SaaS) or as an application service provider (ASP) in a state-of-the- art and secure data centre. Our data centre partner is accessible to customers and interested parties and has many years of GxP know-how. As a matter of course, the data is stored and mirrored in Germany (Hamburg). The qualified data centre meets all current IT security standards and is distinguished by certifications and confor- mities such as ISO 27001, FDA 21 Part 11 Compliance, GxP Compliance and many more. 6
Regulations EU GMP Guideline Swissmedic MPG ISO 13485 MDR 2017/745 FDA 21 CFR Part 11 Laws/ Guidelines/ Standards IFS BRC GMP+ ISO 9001 14001 16949 ISO 15189 17025 7 Regulation requirements The product development process, with respect to regulatory requirements, demands a very high level of quality. Our software solutions take into account the relevant laws, guidelines and standards in the regulated environment, and have been specifically developed against this background. Our products have been launched and validated successfully in numerous companies in the life science industry. Audits As a software provider for companies in the GxP environment, the execution of supplier audits is common practice. During TÜV audits and inspec- tions of the regional council (Germany), our prod- ucts have been audited successfully according to ISO standards 9001 and 13485. Regular audits by our customers and interested parties also con- tribute to the continuous improvement of our process and product quality.
Controlled Documents (SOP Management) Regardless of work/process instructions (SOPs), process descript- tions, test instructions, operating instructions or various other document types, you can create, revise and sign them electroni- cally with our "Document Control“ module. Create/ Edit Set Effective Review Train Approve Release Benefits Create new documents based on approved templates Sign your documents with our electronic GxP-compliant signa- ture The system checks and logs your paper printouts. Printouts are provided with a personalized enforced watermark The system provides further applicable documents and links to other documents as well as the “Periodic Review“ function The integrated reporting facilitates your evaluations and pro- vides an overview of documents and processes Compare the different versions of a document and view the changes Regulation requirements • • • • • • • ISO 9001:2015, chapter 7.5 ISO 9001:2015, chapter 4 EU-GMP guideline, annex 11 FDA 21 CFR Part 11 WHO: “Guidance Document on Good Data and Record Management Practices” EFG-Votum V11002: Requirements for the storage of electronic data EFG-Votum V11003: Requirements for electronic signatures and initials • • • • • • 8
Controlled Documents …to electronically controlled document! 9
Controlled Documents - Creation 10
Controlled Documents - Document Circulation: Review, Approve, Release Document Circulation is defined by your companies configuration. For each document template, a different document circulation can be stored in one or several stages. Thus, it can be flexibly adapted to your requirements and procedures. "Periodic Review" tasks are automatically sent to the author of the document. When the tasks deadline is reached, an automatic re- minder is sent by the integrated reminder and escalation management. Participating in automatic document circula- tion is confirmed by means of the electronic and GxP-compliant signature. Integrated au- dit trails for every document increases trace- ability. 11
Employee Qualification Management (EQM) Extend the "Document Control" module to include the logging of your employees‘ qualifications. Our solution Employee Qualifica- tion Management accomplishes this task. Benefits • Ensure that all employees have the necessary qualifications for their position • Update the qualification level of your employees due to suc- cessful document trainings or (externally) completed trainings • Automatically create training lists of participants • When a new document version is released, automatically send training tasks to the necessary employees • Add comprehensive questions to selected documents and use the electronic exam Configure several repeat intervals for your trainings Check the qualification level of your employees with one click - this can be checked on the basis of a document, an employee or a role. The resulting qualification matrix informs you immedia- tely Regulatory requirements • • • • • • ISO 9001:2015, chapter 7 ISO 13485:2016, chapter 6 EU GMP Guideline Part 1, chapter 2 EU GMP Guideline Part 2, chapter 3 Ordinance for the Manufacture of Medicinal Products and active Pharmaceutical Ingredients section 2, §4 FDA 21 CFR 211 Subpart B • • 12
EQM …to electronic qualification management! 13
EQM - "Read and understood" Task / Qualification Matrix Create different qualification profiles (target qualification) and assign these to relevant doc- uments. Plan individual trainings and training measures such as "Read and understood tasks", "Face-to- face trainings“, "External trainings" and com- bine these with an electronic exam. With one click, the qualification matrix informs you about the current training level of your employees on the basis of their qualification credentials. If required, you can create indivi- dual training measures and repeat intervals for your trainings. 14
EQM - Electronic Exam In the electronic exam, you can create indivi- dual questionnaires, both Right and Wrong or Multiple Choice questions. After successfully completing the electronic exam, the qualifyca- tion level of your employees is automatically updated and displayed in the qualification ma- trix. 15
E-Learning Use the new module “E-learning” to digitally train your employ- ees. Create an e-learning using Microsoft PowerPoint or integrate existing presentations. The e-learning is delivered to the user via the task inbox and can be completed from there. If you are already using our “Employee Qualification Management” module, the E-learning is available there. Benefits • • • • • Easily integrate content from the eDMS / eQMS, such as default and specification documents into e-learning In addition to documents, integrate audio files and videos to illustrate your learning content Participate in e-learning via delivered tasks within the system or via the web-based training portal If you additionally use our module “Employee Qualification Management”, the successful completion of the electronic exam automatically updates the qualification level of your employees Personalize your e-learning using a variety of ready-to-go question templates in PowerPoint: • multiple choice • multiple response • true/false fill in the blanks • • puzzles • drag and drop • sequence • hotspot • matching 18 16
E-Learning Electronic exam 1817
QM Workflows: Complaint, Deviation Control, CAPA, Change Control Control your production processes like claims (Complaint), deviation notifications (Deviation Control), corrective and pre- ventive actions (CAPA) or Change Control (CC) with our electronic workflows. With our integrated solutions, your previously paper- based process is executed completely digitally from recording to finalization. The workflow system automatically forwards the form to the next step or next employee. If time is exceeded, the reminder and esca- lation management takes effect. Task routing is also available. Benefits • • Records you keep today in paper form will no longer get lost, as these are saved electronically right from the beginning The administration costs and runtime of processes are reduced, the quality of results is increased • Generate interconnected process chains, consisting of individ- ual processes, to increase traceability • • Create reports and statistics to keep track of your ISO relevant processes, even if you are not involved in the process The electronic and GxP-compliant signature has been added to these solutions Regulation requirements ISO 9001:2015, chapter 5.1.2 • • EU GMP guideline part 2, chapter 15 • FDA 21 CFR Part 211 & CFR 7 Subpart C • ISO 9001:2015, chapter 8.5.6 ISO 13485:2016, chapter 4 and 7 • • EU GMP guideline part 2, section 13 ISO 9001:2015, chapter 8 ISO 13485:2016, chapter 8 • • EU GMP guideline part 1, chapter 8 • (Complaint) (Complaint) (Complaint) (Deviation Control, CAPA) (Deviation Control, CAPA) (Complaint, Deviation Control, CAPA) (Change Control) (Change Control) (Change Control) 18
QM Workflows - Control your QM processes digitally Deviation Control (DC) Corrective and Preventive Action (CAPA) Change Control (CC) Further Features • Connects with our “Document Control” module • Addressing rules and users • Automatic PDF creation and storage • Adding documents/attachments • Referencing of master data • Audit Trail 20
Process Documentation Since the shift in 2000, international standards such as ISO 9001 pursue an increasingly process oriented approach for planning quality management. Our documentation tool “dls | process documentation“ takes into account of this fact and helps to document, structure and visualize the processes in your company simply and uniformly. Benefits • Structure processes according to individual process properties • Use the automatically generated process map to visualize your business processes • • Processes will be divided into management, core and support processes or be adjusted individually. Structure your processes according to the process levels main process, sub-process and activity/process step • Assign input elements, output elements, process resources, process roles and other elements to processes • Link the processes with already existing documents from d.velop documents (formerly d.3ecm) ECM and digital life sciences QMS • Maintain your process data in different national languages Regulation requirements • • ISO 9001:2015 ISO 13485:2016 21
Process Documentation Connect your respective business processes and build corresponding process chains. On the basis of the stored process data, you can also automatically generate a process manual in several formats. 22
Contract Management Keep track of your contracts. Get reminders for deadlines, like termination or renewal options in multilevel procedures. Give every employee electronic access to documents which are relevant to them. Create new contracts on the basis of text modules, always in the currently released version. Benefits • Deadline calendar and appointment overview • • Every employee has easy access to contracts which are relevant to him/her The system automatically reminds you of termination and other dates • With a click, you receive a list of all contracts including meta data • In conjunction with our “controlled documents” module, you can receive an electronic review, approval and release workflow Regulation requirements • Granular authorization system on contract level • EU GMP guideline part 2, section 16 • Support of different runtime schemes • Automatic generation of folder structures 23
Contract Management 24
Technical Documentation From the individual document via our document management system down to process oriented dossier management, our module “dls | technical documents" supports and simplifies the creation and update of your technical documentation. For example as part of the requirements of the Medical Device Regulation (MDR). Our process oriented dossier management is versatile. For exam- ple it includes the creation of site master files, machine and facility logs, building records, QM handbooks, project folders and many more. Benefits • Seamlessly integrate into our Document Control module • Manage templates for the different structures of your dossiers • Manage tasks for the editors of individual chapters of a dossier (workflow) Check the completeness of your dossiers Check the current editing status of your dossier Create versions of your dossiers and access old versions easily Create comments for your dossiers with different priorities Export the entire dossier or selected parts as a PDF or ZIP file Print the entire dossier or selected parts of it • • • • • • • Use the integrated electronic and GxP-compliant signature as well as audit trail functions • Integrated archiving on the basis of ECM d.velop documents (formerly d.3ecm) 25
Technical Documentation From a messy Fileserver… … to a structured Dossier! 26
References (abstract) 2 7 B e t h e n e x t …
Reviews (abstract) „A high level of advisory competence as well as acting in partnership characterize the successful cooperation, which is why we see Digital Life Sciences GmbH as a long-term partner of our company.“ Silke Sobek, Group Manager ECS – Holopack Verpackungstechnik GmbH “The Digital Life Science team has been supporting us for years to make our processes more efficient and digital. Over the past few years, we have thus been able to successfully implement the GMP compliant document management, employee qualification management and and contract management in our company together. We are happy to build on the positive experiences with the Digital Life Science team and currently have numerous projects in the pipeline that will make our documentation more digital, traceable and centralized. Digital Life Science GmbH is a strong and long-term partner for us." Dr. Nicole Freise-Papke, Process Group Leader QA-Systems - Rottendorf Pharma GmbH „We are a first-class customer and Digital Life Sciences supports us reliably and sustainably with their products and thus helps us to further develop our QMS and to map electronic solutions / workflows taking into account data integrity requirements.“ Silke Schwiertz, Head of QM/QA/QP – MEDICE Arzneimittel Pütter GmbH & Co. KG “Digital Life Sciences GmbH supported us with professionalism and expertise while we migrated to a new electronic quality management system in record time. Six independent document management systems were transferred into one harmonized central d.3 eQMS. The support in implementing the validation requirements for computer-based systems according to GxP and ISO requirements is excellent.” Christine Strubel, Head of Management Systems Quality & EHS - SCHOTT AG 28
Learn more about our solutions from the "GMP Berater" of the publishing company GMP-Verlag Peither. Our company founder and managing director, Thilo Gukelberger, writes as author for this standard work on the subject GMP. With d.velop documents (formerly d.3ecm) as an eDMS basis, you can also optimize comer- cial processes digitally. The d.velop standard solution for e-mail management, incoming invoice processing and the connection to clas- sical ERP systems from SAP, Microsoft or Infor extends your solution to a complete archive, DMS and workflow system. Digital Life Sciences GmbH Am Campus 13 48712 Gescher +49 2542 20201-0 sales@digital-ls.com www.digital-ls.com