Produce real-time comprehensive documentation in each stage of the process, with minimal costs and effort
Increasingly strict regulatory standards for quality and patient safety introduce new challenges for medical devices manufacturers, who need to focus not only on delivering a competitive product that complies with the market regulations, but also to produce documentation that proves this compliance.
We have identified the documentation process as being an important theme in each regulated industry. Our automated reporting solutions aim to solve the need for producing real-time comprehensive documentation in each stage of the process, with minimal costs and effort.
Speeding up the Document Generation Process: A Case Study at a Healthcare Company
Download case study [Download abstract]
Our solutions can help you increase productivity and
enhance the process you adopted, by:
- design and implementation of regulatory compliance documents;
- improve and automate the reporting process from IBM Rational tools;
- generate large-scale documents based on cross-tool reporting;
- custom integration and reporting solutions;
- identify tool needs for your process and reduce documentation costs;
- provide a rational integrated solution across the product development lifecycle;
- adopt rational practices to shorten development time and time to market.
We can help your company to automate the generation of documents
compliant with the industry standards and regulations, including:
- IEC 62304
- ISO 14971
- IEC 60601
- ISO/TR 80002
- 21 CFR Part 11
- ISO 13485
- ISO 62366.
- ISO 9001
- ISO 17363 – ISO 17367
Our automated document generation process relies on IBM Rational Publishing Engine and GEBS Reporting Web Publisher. We also provide custom reporting solutions in the shape of helper tools to cover more complex scenarios and fully meet your requirements.
We offer reporting solutions from Rational tools such as: IBM Rational Asset Analyzer, IBM Rational DOORS, IBM Rational Focal Point, IBM Rational Host Access Transformation Services, IBM Rational Quality Manager, IBM Rational Requirements Composer, IBM Rational Rhapsody, IBM Rational System Architect, IBM Rational Team Concert, IBM Rational Test Virtualization Server, IBM Rational Test Workbench.
1. Software development lifecycle documents
Need for documentation
- Engineers need to show traceability from user needs through to delivered products.
- Manufacturers need to have systems in place to ensure that customer requests and complaints are managed and, if necessary, changes made to products.
- Managers need to be able to track and understand the status of the project in all stages of the development lifecycle.
- Managers need an analysis of project progress and of how teams are working together.
- Teams need to provide insight into the project without giving access to non-project members to their development systems.
Types of documents
Requirements and analysis: System Requirements Document, Requirements Traceability Report, Test Master Plan
Design and development: System Design Document, Interface Control Document (ICD), Software Development Document, Test Analysis Report
Testing: Test Plan, Test Scripts, User Acceptance Test Report
2. Regulatory documents
Need for documentation
- Documentation is needed to prove that products get through regulatory.
- Strict regulatory agencies demand proof of compliance.
- Manufacturers must demonstrate compliance with various standards and regulatory bodies.
- Avoid significant damage that can result from conflicts with regulatory organizations.
- Product failures can cause injury or even loss of life.
- Adopted risk management processes must be documented over the course of design, development, prototyping, manufacture, and postproduction.
Types of documents
Risk Identification and analysis: Risk management plan, FMEA, FTA
Risk Estimation: FMEA, FTA, Reliability prediction, System modeling
Production and post-production monitoring of found risks: FRACAS
3. Manuals
Need for documentation
- Technical writers often have limited resources and time to manually produce high-quality manuals as their companies speed products to market.
- Document style across manuals needs to be standardized
Types of documents: User Manual, Administration Manual, Operating Manual, Label Copy
4. Supply chain documents
Types of documents: System of products identification and traceability, Traceability in supply chain
