Operating instructions are part of Boehringer Ingelheim's internal documentation. The documents are intended mainly for laboratory staff who operate special analytical instruments for the pharmaceutical manufacturing process. To ensure quality and compliance with legal requirements, the operating instructions are subject to a revision cycle within a regulated process. In addition, the device instructions are subject to regular audits. These audits verify that the functioning and, for example, the functional testing of the devices, comply with legal requirements. To meet the needs of the readers and to comply with regulations to keep the documentation complete, the device instructions must be comprehensible, created for the target group, and updated within the revision deadlines in Boehringer's internal document management system.
Project management and revision of operating instructions
In collaboration with the subject matter experts, we write and revise the operating instructions and related templates in Microsoft Word, focusing on applicability and audit safety. Revision of the documents takes place in a restricted and version-controlled area in Boehringer’s document management system. We coordinate process workflows and reviews, make sure that deadlines are met and act accordingly in case deadlines are exceeded. After completion, the operating instructions become available in a read-only environment in the document management system.
Wiki-based style guide and terminology
We also help Boehringer Ingelheim's quality department to create an editorial style guide in a wiki and develop a standard terminology. This includes automatic checks in Microsoft Word. These measures should help all technical authors of Boehringer to create their documents in an efficient and uniform way and tailored for the target group. The measures will also improve content reuse and the writing process.
Our services at a glance
- Create templates for operating instructions
- Create and revise operating instructions and evaluate them with respect to structure, target audience, and style in the role of a technical author
- Assist the Boehringer editorial team with technical documentation
- Organize, manage, and follow-up Boehringer project meetings to revise operating instructions
- Ensure that operating instructions are created according to internal specifications
- Do researches in Boehringer's internal document management systems
- Assist in developing and implementing an editorial style guide in a wiki for target-group-oriented, rule-based, and standardized writing
- Develop a customized terminology solution
- Project management