Documentation Procurement / Creation

Procedure / Report Writing

• Standard Operating Procedures (SOP) / Department Procedures (DP) for Manufacturing / Production / Laboratory
  • Aseptic Bottle / Bag filling SOP revisions and inclusion of QA / QC requirements
  • Nuclear Medical Device Manufacturing use, cleaning, and maintenance of equipment
  • Laboratory equipment use, cleaning, maintenance and calibration
• QA / QC / RA procedures
  • QA policies
  • Incoming material / Inspection / Sampling procedures
  • AQL plan implementation into sampling procedures
  • Document Change Control process
  • Master Batch Record
  • Corrective and Preventive Action
• Statistical / SPC / SQC, DOE and R&R Gage study Reports
• Validation (validation plan, IQ, OQ, PQ, reports)
  • Cleaning
  • Production / Lab Equipment
  • Process
  • Test Method
  • Computer / Software
  • Facility / Utility
• Meeting Minutes
• V&V report
• Budget analysis
• FMEA, FTA, and HA procedures
• Audit Reports and Responses
• Metrology (calibration) Procedures
• Preventive / Emergency Maintenance Procedures
• Document Change Control development
  • Approved document types
  • Approval signature process
  • Revision history

Release of new document, removal and destruction of previous version
Electronic Storage

• Validation of Documentation System on Access, per Part 11 requirements
• Validation of Blue Mountain Equipment tracking / calibration software
• Use of Excel, Access, and FoxPro for storage and retrieval of documentation information
• Password protection and backup of documentation information
• Use of Stratus (ERP) system for document storage and retrieval

Support and Development of ISO 9001 / Quality System documentation structure, per

• Part 4.16
  • Identify and define the quality information to be collected
  • Develop a quality record keeping system, and develop procedures to maintain and control
• Part 4.5
  • Develop procedures to control quality system documents and data
  • Develop procedures to review, approve, and manage all quality system documents and data
  • Develop procedures to control changes to documents and data

Support and development of QSR/GMP based documentation system, per:

• 21CFR Part 820.40 – Document Control
  • Document approval & distribution
  • Document changes and change control
• 21CFR Part 820.100 - CAPA
  • Corrective and Preventive action
  • 21CFR Part 820.180 – Records general requirements
  • Confidentiality
  • Record retention
• 21CFR Part 820.181 – Records Device Master record
  • Device specs, production process specs, QA procedures and specs, packaging and labeling specs, installation, maintenance and servicing procedures & methods
• 21CFR Part 820.184 – Device History Record
• 21CFR Part 820.186 – Quality System record
• 21CFR Part 820.198 – Complaint Files