Technical Writers

PharmOut has Technical Document Writers, experienced in the pharmaceutical, medical device and biotechnology industries. They are available for contracts of any length.

Quality Management Systems

Our Technical Writers are skilled in consulting stakeholders and then writing clear, usable documents that form a key component of an effective Quality Management System. They will comply with your document standards or as recommended by our Quality Experts.

Policies, Standard Operating Procedures (SOP's), Work Instructions and workable Forms can all be developed in a manner consistent with your company's requirements.

If you need advice on drafting ISO 9001 , CFR 820 or ISO 13485 Quality System documents, our document writers work in conjunction with our Quality Consultants to implement a system on your site. This leaves you free to focus on the critical business of running your company.

We can also provide advice on database and document management systems.

Validation Master Plans, Specifications and Protocols

We can write your Validation Master Plans, Site Quality Policies, Quality and Project Plans, allowing you to concentrate on your managerial duties.

We specialise in preparing User Requirements Specifications (URS), Functional Specifications (FS) and Design Specifications (DS) for small companies starting out, as well as large multinational companies.

We have devised a format for these documents that allows them to be easily transferred into Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols.

We also specialise in Equipment Validation and Process validation.

We recommend the use of the ISPE's GAMP V-Model. It provides a clear, easy to understand framework for all your validation efforts.

Templates

If you do not have your own templates, PharmOut can assist you with developing templates for Validation Master Plans, Policies, Standard Operating Procedures, Specifications, Protocols, Manufacturing Batch Records, etc.

PharmOut has Risk Assessment Templates to ensure thorough risk assessment of your processes and software. This ensures compliance with the CGMP, TGA and FDA requirements, contained in ISO 9001, ISO 13485, PIC/S and CFR regulations.

Remember, good validation outcomes start with a well written Validation Master Plans. It should clearly allocate roles, responsibilities and actions with well defined acceptance criteria. You should only start your validation efforts once you have determined your critical control parameters for your process.