Make Compliance Easy

OC11 Systems - One Solution One Validation

eQMS - Quality Management System

SOPs, Training, Change Control, Deviation, CAPA, Investigations, Complaints, OOS, etc.

Manufacturing

Batch Records, Annual Product Review, Log Books, Forms, etc.

Packaging & Labeling

Packaging Record, Label Control, Forms, etc.

Laboratory Control

Log books, Lab Note Book, Monographs, Forms, etc.

Material

Log Books, Certificate of Analysis, Product Specifications, Forms, etc.

Facilities & Equipment

Calibration, Maintenance, Validation, Log Books, Forms, etc.

Part 11 Compliant Spreadsheet

PeP11 LabCal

  • Proven One Validation Concept - Inspected and Accepted by Regulators
  • Part 11 Compliant Spreadsheet
  • Client Server Application

PeP11 LabCal Info

PeP11 LabCal (pdf) Click to Download

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