Governance Frameworks Used in the Pharmaceutical Industry

What matters most and why it matters

Governance in the pharmaceutical industry is not a theoretical exercise. It directly impacts patient safety, regulatory approvals, data integrity, and the company’s ability to operate globally without disruption. Unlike many industries, pharma governance must balance innovation speed with strict regulatory control.

Below is a practical view of the most widely used governance frameworks in the pharma industry, ranked from highest to lower priority based on regulatory criticality and operational impact.

1. GxP (Good Practice) Frameworks – Highest Priority

Includes:

GMP (Good Manufacturing Practice)

GCP (Good Clinical Practice)

GLP (Good Laboratory Practice)

GDP (Good Distribution Practice)

Why it matters:

GxP is the backbone of pharmaceutical governance. It governs how products are developed, tested, manufactured, stored, and distributed. Non-compliance can lead to warning letters, import bans, product recalls, or plant shutdowns.

GxP frameworks ensure:

• Patient safety and product quality

• Data integrity across regulated systems

• Inspection readiness by regulators such as FDA, EMA, and MHRA

• Clear accountability across business and IT functions

Every governance decision in pharma ultimately ties back to GxP expectations. This is non-negotiable and always the top priority.

2. Regulatory Compliance Frameworks (FDA, EMA, ICH)

Includes:

21 CFR Part 11

EU Annex 11

ICH Q8, Q9, Q10

ICH E6 (R2) and E6 (R3)

Why it matters:

These frameworks define how regulatory authorities expect pharma companies to control electronic records, signatures, risk management, quality systems, and clinical data.

They provide:

• Legal acceptance of electronic systems and records

• Risk-based approaches to quality and validation

• Alignment across global regulatory bodies

• A structured quality management model across the product lifecycle

Strong governance ensures these regulations are interpreted consistently across regions and embedded into daily operations rather than treated as audit-only activities.

3. GAMP 5 (Good Automated Manufacturing Practice)

Why it matters:

GAMP 5 provides the governance model for validating computerized systems used in GxP environ

ments. It bridges business processes, IT systems, and regulatory expectations.

Its importance lies in:

• Risk-based validation strategies

• Clear system classification and control

• Scalable governance for ERP, MES, LIMS, QMS, and cloud platforms

• Reducing over-validation while remaining compliant

GAMP 5 is critical for digital transformation initiatives in pharma, especially cloud adoption and AI-enabled systems.

4. Quality Management System (QMS) Frameworks

Includes:

ICH Q10

ISO 9001 (supporting role)

Why it matters:

QMS frameworks ensure governance is systematic, documented, and continuously improved. They define how deviations, CAPAs, change control, training, and supplier quality are managed.

They support:

• Consistent decision-making across global operations

• Controlled change management

• Strong audit trails and management oversight

• Integration between quality, manufacturing, and IT

While not always cited directly during inspections, weak QMS governance almost always leads to regulatory observations.

5. Data Integrity and Computer System Assurance (CSA)

Includes:

ALCOA+ principles

FDA CSA Guidance

Why it matters:

Data integrity is one of the most common causes of regulatory findings today. Governance frameworks focused on data integrity ensure that data is attributable, legible, contemporaneous, original, accurate, and complete.

They help organizations:

• Prevent data manipulation or loss

• Define ownership and accountability of data

• Apply the right level of controls based on system risk

• Support faster validation through CSA principles

As pharma becomes more data-driven, this framework is steadily increasing in importance.

6. Enterprise Governance and Risk Frameworks

Includes:

COBIT

ISO 31000COSO ERM

Why it matters:

These frameworks operate at an enterprise level and help pharma organizations manage operational, financial, IT, and compliance risks in a structured way.

They support:

• Enterprise-wide risk visibility

• Alignment between business strategy and IT governance

• Board-level reporting and accountability

• Integration with platforms like ServiceNow IRM or GRC tools

While not pharma-specific, they are increasingly used to mature governance models in large, global organizations.

7. Information Security and Privacy Frameworks

Includes:

ISO 27001

NIST

GDPR

HIPAA (where applicable)

Why it matters:

Pharma companies handle sensitive patient, clinical, and IP data. Governance around cybersecurity and privacy is essential to protect trust and meet legal obligations.

These frameworks ensure:

• Secure handling of clinical and patient data

• Controlled access to regulated systems

• Incident response and breach management

• Compliance with global privacy regulations

They typically support GxP governance rather than replace it, which is why they rank lower in priority but remain essential.

How REDE Consulting Helps

REDE Consulting specializes in building practical, inspection-ready governance models for pharmaceutical organizations. We help clients move beyond documentation-heavy compliance and toward risk-based, scalable governance that supports growth and innovation.

Our expertise includes:

1. GxP governance and validation strategy

2. GAMP 5 and CSA-based system assurance

3. ServiceNow IRM and GRC implementations

4. Data integrity and audit readiness programs

5. Global regulatory alignment across FDA, EMA, and ICH

We work closely with Quality, IT, and Compliance teams to ensure governance frameworks are embedded into day-to-day operations, not just audit checklists.

Ready to strengthen your pharma governance?

If you are modernizing systems, preparing for regulatory inspections, or struggling to scale governance across regions, REDE Consulting can help.

Get in touch with us { info@rede-consulting.com } to discuss how we can design a right-sized governance framework tailored to your regulatory landscape and business goals.