Cleanroom Management Associates Incorporated



Knowledge, Experience, Dedication, Integrity


Company Description
Services
Research Request



Online Consulting
Onsite Consulting
Technical Writing


Technical Writing
Standard Operating Procedures | Manuals | Publication Order Form

TECHNICAL DOCUMENT DEVELOPMENT

Development of technical documents by our professional staff ensures that documentation is correct and current with all standards and practices. In-depth interviews are used to integrate corporate goals, culture, product requirements, facility restrictions, and compliance criteria.

Extensive experience writing training manuals, workbooks, standard operating procedures, specifications, bid documents, and text method applications guarantees immediate utilization of the documentation.

Specific documentation contracts include:

  • Training & Sales Manuals and handbooks
  • Course handbooks
  • Standard operating procedures for:
    • Build clean protocols
    • General manufacturing requirements
    • Housekeeping and janitorial maintenance
    • Sanitizing and disinfecting
    • Equipment installation
    • Equipment repair
    • Aseptic handling
    • Admitting materials and equipment into a cleanroom
    • Spare parts decontamination protocols
  • Purchasing specifications
  • Clean manufacturing protocols
  • ISO documentation
  • Test method applications
Contract fees are based upon the project, an annual contract or an hourly fee and includes sample documentation.



TECHNICAL DOCUMENT REVIEW

Documentation is the foundation of quality manufacturing operations. As technology changes with new standards and practices, internal documentation such as procedures, specifications, and protocols are frequently not updated. Scientific and technical advancements are often overlooked. To ensure that operations are being conducted properly and current procedures are being followed, an annual review of internal documentation is mandatory.

Our professional writers maintain a vast library of technical data related to every industry and product type. This data and extensive experience in technical writing is combined to review and update internal documentation such as:

  • Standard Operating Procedures
  • GMPs
  • Training Manuals and documentation
  • Purchasing specifications
  • Clean manufacturing protocols
  • ISO documentation
  • Test method applications
The review includes noting discrepancies with current published standards, incorrect or improper contamination control practices such as gowning, housekeeping, product handling, etc.

Conflicts between various internal documents are noted. A comprehensive report is issued indicating recommendations and revisions with references to document, paragraph and section numbers as applicable.

Contract fees are based upon the project, an annual contract or an hourly fee and includes sample documentation.

Company Description | Services | Research Request







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