Data Integrity

QxP Pharma Consultants – Your Partner in Data Integrity Risk Assessment and Remediation
QxP Pharma Consultants & GMP Services is a leading name in ensuring Pharmaceutical Data Integrity Compliance across India.
As a trusted partner to pharmaceutical, biotechnology, and life sciences companies, we specialize in implementing robust Data Integrity in GMP Environments that align with global regulatory expectations.
With deep domain expertise, particularly in GMP Services Providing in Ahmedabad and pan-India coverage, QxP delivers end-to-end support to safeguard critical data across the product lifecycle.

In the current regulatory landscape, Data Integrity is no longer just a compliance checkbox—it’s a core element of quality management and patient safety.
Whether it’s 21 CFR Part 11 Data Integrity, WHO Data Integrity Guidelines, or ALCOA+ Principles in Pharma, our experts help you meet the evolving expectations of the US FDA, MHRA, EMA, WHO, and other regulatory authorities.

Why Data Integrity Matters in the Pharma Industry?
Data Integrity refers to the completeness, consistency, and accuracy of data throughout its lifecycle.
In regulated industries, especially pharmaceuticals, compromised data can lead to regulatory citations, product recalls, or worse—risk to patient safety.

Key Regulatory Drivers:
21 CFR Part 11 Compliance
EU Annex 11
WHO Technical Report Series 1019
MHRA Data Integrity Guidance
PIC/S PE009
To maintain public trust and regulatory approval, companies must adopt structured Data Governance in Pharma, supported by validated systems and well-trained staff.

QxP Pharma Consultants: Experts in GxP Data Integrity Services
As a premium Pharma Consultant in India, QxP Pharma Consultants in Ahmedabad offers comprehensive GMP Data Integrity Audits, Data Integrity Gap Analysis, and Computerized System Data Integrity Validation for all GxP systems.
Our specialized GMP Services Providing in India include:
Data Integrity Risk Assessments
Audit Trail Review Compliance
Data Integrity in Laboratory Systems
Electronic Records and Signatures Compliance
Data Integrity Monitoring Solutions
We help clients align with ALCOA+ Principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available) and ensure data remains reliable across digital and manual systems.

1. GMP Data Integrity Audits
Our seasoned auditors conduct detailed on-site and remote GMP Data Integrity Audits, evaluating paper-based records, laboratory instruments, ERP systems, LIMS, and MES platforms. Audits are mapped to FDA and WHO expectations and focus on risk-based controls.
Audit Highlights:
Review of audit trails
Assessment of system controls and backups
User access controls and roles
Record retention and version control
Detection of data manipulation risks

2. Data Integrity Gap Analysis
Identify weaknesses before regulatory agencies do. Our Data Integrity Gap Analysis benchmarks your systems and procedures against global best practices. We help pinpoint non-compliance and provide a tailored remediation roadmap.
Focus Areas:
Laboratory records and instruments
Production and batch records
Quality management systems
Electronic data storage systems

3. Data Integrity Risk Assessment
QxP Pharma Consultants conducts comprehensive Data Integrity Risk Assessments to prioritize corrective actions. Our methodology is aligned with ICH Q9 risk management and considers:
Process criticality
Data lifecycle vulnerabilities
Human interaction and training gaps
Technical and procedural controls
This service is vital for firms seeking pre-inspection readiness or remediation following warning letters.

4. Electronic Records and Signatures Compliance
We ensure your systems comply with 21 CFR Part 11 and Annex 11 requirements for electronic records and signatures. This includes:
Digital signature implementation
Role-based access control
System validation and audit trail retention
Electronic batch record (EBR) compliance

5. Computerized System Data Integrity Validation
We specialize in validating GxP computerized systems used in manufacturing, QA, QC, clinical, and R&D environments. Leveraging GAMP 5 methodology, we ensure systems are:
Appropriately validated
Data secure and access-controlled
Equipped with comprehensive audit trails
Integrated with quality management workflows
This includes Ensuring Data Integrity in CSV (Computer System Validation) and integration with ERP/LIMS/MES platforms.

Data Integrity in Laboratory Systems
Modern analytical labs rely heavily on computerized instruments. QxP assists clients in maintaining Data Integrity in Laboratory Systems, covering:
Chromatography data systems (CDS)
Laboratory information management systems (LIMS)
Standalone analytical instruments
Validation of software and firmware updates
We offer detailed Audit Trail Review Compliance to meet FDA and MHRA scrutiny.

Regulatory Support for Data Integrity Remediation
Whether responding to an FDA 483 observation or a WHO deficiency, QxP’s team provides complete regulatory remediation and follow-up support, including:
CAPA development and implementation
Investigation of root causes
Interaction with global regulatory authorities
System updates and documentation control
We help you close regulatory gaps efficiently with sustainable solutions.

Why Choose QxP Pharma Consultants?
As a pioneer in GMP Services Providing in Ahmedabad and trusted partner across India, QxP brings a rare blend of:
20+ years of GMP and data compliance experience
In-depth knowledge of US FDA, EMA, WHO, MHRA regulations
Tailored support for small, medium, and large enterprises
Turnkey data integrity solutions—from audit to validation
Ongoing support for regulatory filings, audits, and remediation
Our goal is to transform your data from a liability into a regulatory asset.

Partner With India’s Leading Pharma Data Integrity Consultants
If you’re looking to strengthen Pharmaceutical Data Integrity Compliance or prepare for your next regulatory audit, QxP Pharma Consultants & GMP Services is your ideal partner.
Whether you’re based in Gujarat or across India, our expertise in GMP Services Providing in Ahmedabad and nation-wide delivery ensures world-class compliance with a local touch.
Contact QxP Pharma Consultants in Ahmedabad today to learn how our Data Integrity in GMP Environment solutions can help secure your operations.

QxP Pharma Consultants – Your Partner in Data Integrity Risk Assessment and Remediation