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Italiano
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I will write or review your pharmaceutical gxp sops and CSV documentation
Mpharm
I am a Post graduate M. Pharma Proffesional and Regulatory Affairs specialist with extensive experience reviewing technical data against international standards. I specialize in bridging the gap betwe...
Informazioni su questo servizio
Are your engineering, laboratory, or technical teams struggling to format audit-ready compliance documents? Let an expert handle it.
I am an MPharm graduate and Regulatory Affairs professional with extensive experience reviewing technical data against international standards. I specialize in bridging the gap between raw pharmaceutical workflows and strict regulatory frameworks like USFDA 21 CFR Part 11, GAMP 5, and ALCOA+ Data Integrity.
Send me your raw bullet points, laboratory notes, or rough software workflows, and I will transform them into clear, structured, and compliant documents.
What I offer:
- Standard Operating Procedures (SOPs): Equipment operation, software usage, and log maintenance.
- CSV Documentation Review: Refining User Requirements (URS), Traceability Matrices, and Functional Specs.
- Validation Protocols: Formatting and proofreading IQ/OQ/PQ testing scripts.
- Gap Analysis: Auditing existing drafts to catch compliance red flags before an inspector does.
Note: I provide document writing and compliance review based on regulatory frameworks. I do not provide custom software coding.
Lets make your documentation audit-ready. Place your order or send a message to discuss.
Settore:
Medico e biotecnologico
Lingua:
Inglese
Preferenza per lo stile di consegna
Informa il freelance di eventuali preferenze o preoccupazioni relative all'uso di strumenti di IA nel completamento e/o nella consegna dell'ordine.
FAQ
What do I need to provide to start the order?
Please share your raw laboratory notes, rough process workflows, or system blueprints. I will take your technical data and structure it into clean, audit-ready compliance documents.
Are my technical documents and blueprints safe with you?
Yes, absolutely. Your records, raw workflows, and project files are kept strictly confidential. I never share your data with any third party, and your corporate records are completely secure.
Can we sign a Non-Disclosure Agreement (NDA)?
Yes. If your company policy requires an NDA, you can send your document directly in our Fiverr chat. I will sign and return it to ensure legal confidentiality before we begin.
Do you provide the technical engineering design or software coding?
No. I support you strictly with technical writing, formatting, and compliance review. The technical blueprints, workflows, and process specifications must be provided by your engineering team.
Do you offer revisions if my Quality Assurance (QA) team requests changes?
Yes. I provide revisions to ensure the final document perfectly fits your company’s internal templates and satisfies your site’s QA requirements.
