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How to achieve complete, compliant documentation of the product lifecycle
Product documentation comes with complex requirements for manufacturing verticals such as automotive, chemicals or medtech. It’s the backbone for describing the use of products throughout all life cycle phases, anchoring transparency within product processes and providing security for manufacturers—because effective product documentation ensures quality, compliance and efficiency production-wide.
Keep reading to learn how to create compliant product documentation and which software can support you over the whole life cycle of your products.
What is product documentation?
In short, it’s a collection of documents containing product-related information. This information spans the entire life cycle of a product, from development and production, to use, maintenance and disposal. Contents are directed at various different stakeholders, including developers, manufacturers, suppliers, regulators, and not forgetting end users.
How is product documentation structured?
The standard way of structuring your documents varies depending on which market segment or industry sector you operate in. Industry-specific requirements, regulatory requirements and your target user groups all have a bearing on how your product documentation will look and the information it contains.
Product documentation is then created following a standardized logic to ensure a uniform structure and the use of appropriate terminology to communicate information with different audiences. Also, it must always be presented in a way that allows clear translation.
What kinds of product documentation are there?
Product documentation includes all documents that are generated over the life of a product or that will be needed in future for repairs, maintenance, further development or use.
- Technical documentation
Technical documentation is where all of the information is captured that users or product stakeholders need to safely use a technical product and correctly assess risks. Internal documentation begins with the initial development of a product and only ends after the retention period and provides evidence of compliance to the authorities. By contrast, external documentation is a collection of all information relevant for end users, such as user manuals and assembly instructions. - Regulatory and quality documentation
Regulatory and quality documentation provides evidence that companies comply with legal requirements in their product processes, ranging from compliance and test reports to audit certificates, quality control records and GMP documents. - Development and user documentation
It’s a long way from the product development phase to actual use, and product documentation tracks every step of the journey. It starts with the development documentation, containing requirements, designs and prototype reports to show precisely which steps the product has passed during development. On the other hand, user documentation is aimed at end users and technicians and explains how to use the product safely. It includes user manuals, installation instructions and information on maintenance and safety. - Project and process documentation
Roadmaps and targets are an intrinsic part of the product process. Project and process documentation captures all plans—from development to production—including the timelines for the various implementation phases. It provides clear explanations of business and product processes so they can be used to manufacture the product.
What are the contents of product documentation?
The components of product documentation differ from product to product. For instance, the requirements for software are very different to those for technical equipment and machinery. Correspondingly varied are the stylistic devices used—images, text and drawings are some of the more typical elements.
For instance, product documentation might contain:
- Product description
- Prototype reports and change logs
- Manufacturing regulations
- Bill of materials
- Approval documents and certificates
- User and installation guides
- Declarations of conformity
- Risk assessments and safety information
- Brochures and flyers
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Read nowProduct documentation in 3 steps
Product documentation contains information from many different areas, including audit reports, marketing materials and manufacturing regulations. Equally diverse is the team responsible for implementing it within the company and will typically include engineers and technical writers, as well as interdisciplinary support provided by stakeholders from marketing and sales, project managers and for some products, IT admins.
1. Needs and requirements analysis
Two aspects dictate the structure of product documentation: legal standards and the requirements of stakeholders such as customers or suppliers.
While legal standards stipulate which documents must be included as mandatory, the demands of stakeholders for further documents containing product information must also be considered. Collectively, this produces clear and complete documentation of all data over the product life cycle.
2. Process steps and content
The contents of product documentation come from various sources:
- Safety sheets and risk assessments from security officers.
- Database change logs from IT admins.
- Product brochures from marketing and sales.
- Project plans and change logs from project managers.
- Mandatory approval documents from legal advisors.
- Production documents and work instructions from production engineers.
Construction drawings from development engineers.
The technical writer draws up instructions, descriptions, safety information and other content in collaboration with the various roles to ensure standardized and consistent terminology is used.
3. Publication and updates
The documentation for a product is updated on an ongoing basis. Accordingly, product stakeholders—product managers, managers, technical writer, etc.—check to ensure all new information is present and correct throughout. Once they are satisfied, they approve and publish the amendments.
Product documentation: Mandatory for all manufacturers
Manufacturers are legally required to prepare product documentation for every product. Every change made—either to the product itself or to the process—must be recorded in the documentation. Product documentation therefore serves as evidence, since manufacturers can show compliance with all legal requirements in respect of a product at all times—from development to manufacture, from modification to disposal.
Conversely, product documentation protects manufacturers against liability risks by clearly documenting that the company has complied with legal requirements at every step of the product process.
Legal requirements
A CE mark is a requirement for many products sold in the EU and must be included in the product documentation. Whether or not your product needs a CE mark is governed in regulations such as the EC Machinery Directive. Generally speaking, the CE mark requirement applies to all products that fall within the scope of the European directive on health, safety, electromagnetic compatibility and environmental protection.
Product documentation is an essential prerequisite for obtaining the necessary regulatory approvals and certifications. For instance, pharma companies are required to maintain GMP documentation by logging detailed data on production and quality assurance.
Product liability
Product liability is an area in which product documentation plays a particularly important role for manufacturers. If an audit is scheduled or damage is reported, companies are required to provide evidence of full and complete product documentation. Ideally, it will offer rigorous proof that the manufacturer took all necessary steps to ensure the safety and quality of the product.
Complete product documentation is equally essential in the event of quality issues, as it allows them to be traced back to source. Product stakeholders can retrospectively identify errors, and in the case of recalls, rapidly and above all precisely locate components.
Key standards
A further important factor is ensuring that the information contained in your product documentation is presented in line with the relevant standards. These standards tell you how to make information available and which information to include in your product documentation. Here are some recognized standards explicitly for technical product documentation:
- IEC/IEEE 82079-1: Specifies general requirements for technical documentation, such as structure, design, and presentation of information to ensure it is clear and usable.
- DIN EN 82079-1: Provides guidelines on creating user manuals, focusing on content, language, and layout to make the manuals user-friendly and effective.
- ANSI Z535.6: Defines standards for warnings and safety notices that must be included in documentation, ensuring they meet legal and safety requirements.
- DIN EN ISO 17100: Focuses on translating technical documentation, including information on the use of translation software and ensuring translation quality.
Retention periods
In a broader sense, product documentation does double duty by, on the one hand, providing evidence of every step taken by the manufacturer during the product life cycle and, on the other, showing where this evidence is located. In other words, it explains where documents are archived and managed.
This is essential, since product documentation consists of objects that are covered by statutory retention periods. Your company must retain its product documentation for ten years. Inactive documents are stored in an audit-proof archive.
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Read nowWhy product documentation is relevant for business
Document collections and product documentation pursue several objectives. Not only are they essential before a manufacturer can bring a product to market and therefore a prerequisite for obtaining the relevant approvals, they also ensure every step of the journey is traceable. The result? All completed steps are documented and serve as evidence for authorities and auditors at any time.
This along with the continual evolution of documentation brings greater complexity, since multiple stakeholders are constantly adding documents to the pool, which are then revised for understanding by technical writers—in some cases in several languages if the product is sold internationally.
The highlights of product documentation at a glance:
- Comply with legal requirements at all times
- Manage documents in real time
- Create clear, standardized product documentation
- Archive items in the long-term archive audit compliantly for at least ten years
- Keep different product stakeholders up to date
- Safeguard the traceability of product data at all times
Product documentation in Doxis
A document management system (DMS) serves as a centralized hub for all documents created throughout a product's lifecycle. It enables you to efficiently manage active files while securely archiving inactive content in compliance with audit requirements. Here are three key benefits for your business:
- A DMS combines a robust content management platform with a secure archival system.
- A DMS streamlines and automates archiving processes for greater efficiency.
- A DMS accelerates workflows, saving time and boosting productivity.
Doxis goes beyond the basics, delivering these capabilities and much more.
What is Doxis?
Doxis is an enterprise content management platform that unifies and streamlines document, transaction, and collaboration processes across your organization. For example, you can use Doxis as a DMS to create, manage, and archive product documentation, seamlessly enhancing your product information management (PIM) system. The best part? You continue working in your PIM as usual—Doxis operates in the background, ensuring effortless integration and smooth management of your product documentation across multiple systems.
Product documentation in Doxis: How it works
Hey Doxi, how does Doxis work as a software solution for product documentation?
- Collects your documents: Doxis collects all documents generated over the entire life cycle.
- Manages documents in folder structures: Doxis organizes your product documentation by automatically assigning documents to the right eFiles.
- Digitalizes your workflows: Doxis standardizes document management workflows based on your internal processes.
- Sends deadline reminders: Doxis lets you know well in advance of any certifications or patents due to expire and automatically triggers the right renewal workflow.
- Archives documents long term: Doxis compliantly archives your information and meets long-term archiving requirements.
Map the entire product lifecycle with Doxis
Product documentation begins with the idea for a product and ends with its disposal. It essentially maps the entire lifespan of a product. Legal requirements determine how this documentation looks. Manufacturing verticals in particular have to consider industry and product requirements to ensure their product documentation is correct.
Product documentation is considered consistent if it is presented in a standardized way and is translatable, easy to understand and meets all applicable requirements. With Doxis, all of the documents that make up your product documentation can be worked on and retrieved as evidence from the archive at any time.
Ready to discover Doxis in action? Reach out and book a demo! Our experts will be happy to show you its powerful capabilities.
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