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A ProPharma Group knowledge center & resource

Our Policy and Procedure Approach

Meet with you to discuss what makes your organization unique, e.g.,

  • Industry-specific regulations, e.g., AOPO, CAP, COLA
  • Organization structure, roles, and responsibilities
  • Computer systems and tools already in use for records and approvals

Tailor our standard suite of documents to fit your organization

Solicit your feedback on the preliminary suite of documents and make adaptations before finalizing the content.

Develop a Quality Manual to summarize the Policy and Procedure framework and provide an overview for employees, auditors, and inspectors.

Policy and Procedure Development Process

Instead of building from scratch, a comprehensive, pre-established library of SOPs, templates, and forms is utilized—fully aligned with global data integrity requirements from the US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and PDA. This approach accelerates implementation, reduces risk, and provides a strong, inspection-ready foundation that can be tailored to the unique needs of each organization. 
Data Integrity Policies and Procedures Example

Here are the steps we take:

  • Meet with you to discuss what makes your organization unique:
    • Industry-specific regulations, e.g., AOPO, CAP, COLA
    • Organization structure, roles and responsibilities
    • Computer systems and tools already in use for records and approvals
  • Tailor our standard suite of documents to fit your organization.
  • Solicit feedback on the preliminary suite of documents and make adaptations before finalizing content.
  • Develop and Quality Manual to summarize the Poliy and Procedure freameowrk and provide an overview for employees, auditors and inspectors.

Data Integrity Training

Delivering the right level of training at the right time and frequency is critical for ensuring that the principles of data integrity become part of company culture.

We have a catalog of Data Integrity training courses which can be provided on ‘as is’ or tailored to include examples from your daily operations.

Short training courses on Data Integrity Principles, suitable for Data Integrity program implementation and annual refresher training.

Longer training courses on advanced Data Integrity topics such as:

  • ALCOA in Practice
  • Data Integrity Roles & Responsibilities
  • Data Governance Models
  • Digital Signatures
  • Computer System Validation