Data Integrity & Compliance
Providing Platforms and Well-Defined Processes for Improving the Accuracy, Completeness, Consistency and Security of Data.
Data Integrity and Compliance are critical for ensuring safety, improving efficacy and meeting regulatory standards for biotech and pharmaceutical manufacturing companies. The lack of data integrity management and implementation within the industry may result in costly non-compliance related fines, product recalls, and/or consent decrees. BioPharma Consulting Group assists your operation to focus on data integrity and compliance to ensure that all records are complete and accurate, well maintained throughout the entire production process and sustainable to the conclusion of the document lifecycle.
Biotech & Pharmaceutical Data Integrity & Compliance Consulting Services
BCG builds a foundation of all core work on cGMP (current Good Manufacturing Practices) and the ALCOA+ principles. The acronym requires data to be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring and Available.
To achieve data integrity and compliance at the highest standards, biopharma companies must follow industry regulations such as cGMP, Global Pharmacopeia’s, EudraLex, ICH guidelines and Code of Federal Regulations (e.g. 21 CFR Part 11). These guidelines dictate how data and information is collected, processed, stored, secured, and archived. The workplace must also have established processes to regularly monitor their data with audit trails to ensure compliance, accuracy and completeness.
Examples of Data Integrity & Compliance in the Workplace:
- Implementing appropriate data access and controls.
- Monitoring user permissions, audit trails, and encryption technologies.
- Minimizing human error during data entry.
- Training staff on proper data handling practices.
- Instituting double-entry checks and validation protocols.
- Utilizing automated technologies to reduce manual errors.
Implementing data integrity and compliance policies which meet all regulatory guidelines can be a complex process. At BioPharma Consulting Group we will ensure that existing policies meet requirements and implement processes which are essential for the safety and efficacy of products while maintaining and improving the reputation of the company. By following industry regulations, applying the most suitable detection measures, and using automated technologies, clients can secure their data with confidence and paramount quality. Contact us to discuss how to ensure that your company is maintaining its data integrity and compliance with the highest possible standards.
Biotech & Pharmaceutical Consulting Services
Our Quality Assurance services focus on improving quality, integrity and compliance by providing certainty of the product and data. Guaranteeing effectiveness and efficiency as per client expectations and regulatory requirements with regard to patient safety.
BCG will manage client projects with technical competencies focused on quality design efficiency through customized strategies to meet all company goals and produce completed projects compliant to objectives and timelines.