With the CompendAlign™ program, our team will conduct a thorough gap assessment of your analytical test methods, SOPs, and specifications with the goal of understanding what is required to ensure compliance with pharmacopeial standards. From the gap assessment, we will propose an action plan to resolve observed gaps with the end result being full compliance.
This program includes all aspects of the CompendAlign™ program but goes further to ensure your continued compliance with pharmacopeial standards by conducting gap assessments against new or revised compendial standards on an ongoing basis. By implementing CompendAssure™, you can ensure full compliance prior to the intended effective date of the new/revised articles.
Looking for Assistance with Other Quality Systems? Let Us Handle the Work
Our extensive experience and continuous personal development ensures that we are proficient in the following:
Out of Specification (OOS) Investigations
Quality System Implementation
Manufacturing Deviation Investigations
QC Laboratory Efficiency Assessments/Improvements
Data Integrity Assessment
Computer System Validation/Data Migration Plans/Decommissioning Plans
Instrument Qualification (DQ/IQ/OQ/PQ)
Annual Product Reviews
LIMS and Chromatography Data Acquisition System Implementation/ Upgrades