| |
TECHNICAL WRITING
The mission of NHP Compliance’s technical writing services is to meet GMP
documentation requirements and deadlines in a cost-effective manner, with
minimal disruption of day-to-day operations.
We can write and/or revise documents for manufacturing, laboratory, or
general quality assurance operations, including:
- Standard Operating Procedures (SOPs) and policies
- Work instructions
- Quality records
- Specifications
For new documents, our technical writers collect background information and work
with the subject matter experts (SMEs) to understand what is required. The SME
may be management; often it is the shop floor operator or mechanic. Once a
document is drafted, it is reviewed with the SME, and where appropriate (e.g.,
quality records, batch records), it is trialed on the shop floor prior to final review
and approval. For all documents, our associates coordinate the review and
approval process with all stakeholders to ensure everyone using the document
and approving the document has an opportunity to provide feedback.
We also offer SOP-based training on approved SOPs. See GMP Training for more
information.
For importers, distributors, and wholesalers of drug products, we can quickly and
efficiently develop a Quality Manual (an interlinked system of SOPs and Quality
Records) that is customized for your quality control processes.
See QAP Services™ to learn more about our Quality Assurance services.
NHP Compliance technical writing services ensure:
- Finished Standard Operating Procedures (SOPs) and related
documents are clear, accurate and easy to use
- Content meets regulatory requirements
- All documents are written in company's preferred style/format
- Work is completed quickly; our studies show that your staff saves (on
average) 80% of the time it would take for them to generate the
technical document themselves
- Work is performed with minimal intrusion: most work is done off-site;
office space, computers, support staff are not required from client
- You avoid hiring new permanent or contract employees
- Your existing staff stays focused on regular business
- Impact on your bottom line is minimized
|
