Technical WritingManuals, procedures, specifications... if you are like most companies, your in-house staff do not have sufficient time or experience to adequately prepare all of the equipment- and systems-related GMP documentation required in the Life Sciences. As a result, GMP documentation is often done poorly, if at all.
At the same time, 21 CFR Part 11 Electronic Records; Electronic Signatures is regaining focus with FDA and other regulatory inspectors. Adequate documentation is becoming more than just a "nice to have" – it is a "must have" to avoid 483's and Warning Letters.
If you are an Equipment or System Manufacturer, your Pharmaceutical, Medical Device, and Nutraceutical customers will be looking to you to provide them with the GMP documentation they require. Providing specialized documentation is becoming a requirement for making the sale. You cannot afford to fall behind by not providing adequate documentation that satisfies the requirements of 21 CFR Part 11 or other regulations.
Our professional technical writers are experienced GMP compliance specialists. They have hands-on experience both in the field and in the office – they get dirty as much as they sit behind a desk!
We will use advanced document design and control tools to create superior GMP documentation for you, including:
- URS, FRS, DDS Specifications: User Requirement Specifications, Functional Requirement Specifications, Detailed Design Specifications. Many Equipment Manufacturers turn to Tanis to create these specification documents for them.
- Manuals: User, Administration, and Maintenance Manuals for equipment manufacturers, as well as for in-house developed applications and systems.
- Help Files: Online Help files for software and systems.
- Standard Operating Procedures (SOP)
- Process Descriptions and Procedures
- Policy Documents
Contact us to learn more about our cost-effective, comprehensive technical writing services.
