Written By: Mattew Greer, Technical Writer, PSC Biotech®

Your cGMP documents must comply with the applicable laws and regulations.  They don’t have to be easy to understand but they should be.  Writing compliant and easy to understand and use documents, that are “good” documents, is hard and time consuming work.

Easy to understand and use documents reduce the possibility of errors and increase understanding.  You want the best facility, equipment, and personnel.  You should want the best documents as well.  Good documents will save you time and money and will help to minimize human errors.

You can write good documents.  It just takes time and resources.  Sometime, lots of time and resources that you could make better use of doing something else.  So why PSC®?  Simply put, PSC® can do it for you and let you concentrate on running your business.

PSC Biotech® employs a team of skillful technical writers with the ability to create any documentation needed to help your operations run effectively and efficiently. If you are looking for documentation for qualification of equipment and systems, our writers can draft “good” documents for your Quality Management System that meet your goals, actual practices, and industry standards. PSC® writes whatever you need, including:

  • Easy to use templates
  • Policies
  • Standard Operation Procedures (SOPs)
  • Qualifications protocols
  • Logbooks
  • Protocols
  • Reports
  • Risk Assessments
  • Gap Analysis Documentation
  • Forms

When PSC® writes your documents, whether it is one, a few, or an entire quality management system, you also have access to PSC’s® network of Subject Matter Experts (SMEs) who know global laws, regulations, and guidance documents.  PSC® writes every document to conform to the way you operate and to ensure regulatory compliance.

PSC® can write your documents on-site or remotely.  PSC® can assign a dedicated writer or assemble a team, depending on your wishes, the volume of documents and the time frame for delivery.  Our team will work with your team to get you the compliant documents you need.

About PSC Biotech®

PSC Biotech® is a leading Life Sciences and Biotechnology consulting firm.  PSC® strives to provide you with solutions to your needs that are cost-effective and meet your quality requirements.  PSC Biotech® can provide our electronic Quality Management System (eQMS) software, ACE®, to process, control, and manage not only your documents but also integrate the training into a single system.  ACE® is flexible, so the workflow is your workflow, not a rigid, inflexible workflow that doesn’t reflect how you operate your business.

If you need technical writing, PSC Biotech® is happy to help. PSC Biotech® can help with almost all of your needs.  If you don’t see what you need, call us!  It is our pleasure to address your business needs with the utmost care and concern. Contact us today.