Information Technology (IT) & Data Integrity
What is Data Integrity?
DEFINITION: "Data Integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)" - FDA Guidance Data Integrity and Compliance With Drug cGMP
Regulatory agencies are focusing heavily on data integrity. As a result, significant gaps and risks are being identified across all life science industries, and authorities have come down hard on organizations with inadequate systems or controls in place. Therefore, it is imperative that firms thoroughly evaluate and rigorously improve the processes and mechanisms employed to establish and preserve the integrity of data used across both the development and commercial product lifecycles.
How data is captured, managed, maintained and retrieved is a complex challenge from early development through product commercialization. Keeping up with the rapidly changing landscape of regulatory requirements and data management technology can be overwhelming. When you are confident in the integrity of your data, the confidence in the decisions you make using that data improves dramatically. MEDVACON provides real-world expertise to help you develop and implement practical, efficient, and sustainable processes and controls that enhance the integrity and compliance of your data management practices.
ALCOA
What is ALCOA? The five data integrity attributes as defined by the FDA:
- Attributable: Data must be stored so that it can be connected to the individual who produced it. Every piece of data entered into the record must be fully traceable in time.
- Legible: Data must be traceable, permanent, readable, and understandable by anyone using the record. This also applies to any metadata attached to the record.
- Contemporaneous: Data must be fully documented at the time they are generated or acquired.
- Original: Data must be the original record or in a certified copy. The data record should include the first data entered and all successive data entries required to fully understand the data.
- Accurate: Data must be correct, truthful, complete, valid and reliable.
MEDVACON delivers leading Data Integrity and Computer System Validation services that are designed to help reduce the overall cost of compliance for Life Sciences organizations. We offer our clients comprehensive services, including leadership and a range of strategic solutions and tactical services that provide cost-effective and comprehensive compliance and validation. The MEDVACON team of highly-qualified consultants can deliver a broad suite of solutions in areas of computer systems validation, infrastructure qualification, IT Quality Management, and process improvement.
- Risk-Based Computer System Validation
- Software QA and User Acceptance Testing
- Software Vendor Audits
- Gap Assessments and Remediation
- SDLC Methodology Development
- SOP Development
- Project Management
- 21 CFR Part 11 Compliance and Assessments
- IT Policies and Procedure Development
Computer Software Validation is a formalized, documented process for testing computer software and systems, required by 21 CFR 11.10(a) and Annex 11, Section 4. The FDA and other regulatory bodies require validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems. Failure to validate systems is one of the leading reasons a business is issued a 483. MEDVACON can validate all of your software, databases, spreadsheets, and computer systems, and develop the appropriate documentation for all phases of the software life cycle. We have written and executed validation packages for systems of all sizes. We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package. MEDVACON will follow your existing validation procedures or provide your company with validation standards. Our validation methodology ensures validation deliverables that are in line with industry standards & best practices, focus resources towards the most critical system functions, and complete the validation projects efficiently.
Example Projects:
FDA Inspection Readiness Audit – Testing Laboratory
MEDVACON was engaged by a client that provides specialized testing expertise to the medical device, pharmaceutical and consumer products industries to conduct multiple services, including a FDA inspection readiness audit. MEDVACON experts assessed (and improved upon) the state of cGMP compliance at the client’s CA facility. MEDVACON’s efforts focused on computer controls, utilization, and processes in the lab. The client was operating systems manually, using a closed loop system for lab control procedures; however, the MEDVACON team assisted them in migrating to a cloud-based system. MEDVACON also assisted with the development of a Data Governance Policy and Data Integrity Policy. The client was extremely appreciative of the efforts and has engaged MEDVACON to conduct additional ongoing consulting services.
QA Laboratory CSV / Data Integrity – Pharmaceutical Manufacturer
MEDVACON was engaged by a pharmaceutical manufacturer to provide computer system validation and a data integrity analysis related to spreadsheets that had been used in the laboratories for clinical product release analysis and reporting. MEDVACON established a Validation Plan and data integrity approach to ensure that the spreadsheets were locked down, version controlled, protected, and validated. A data integrity analysis was performed whereby MEDVACON deployed a team of CSV/DI Analysts to run all input datasets through the new, validated, spreadsheets and compare the results to that of the original spreadsheets output. The data was manually verified to ensure compliance and the regulatory filing. The FDA reviewed the filing and the approach and there were no findings due to the CSV and DI activities performed.
Clinical IT Systems cGMP & Quality Audits
For a fully integrated oncology drug research development client with expertise in drug discovery, crystallography, medicinal chemistry, preclinical development, pharmacology, and pharmaceutical development, MEDVACON conducted IT CSV/GMP clinical system supplier audits in conjunction with the client’s internal quality department. CP prepared the audit agenda, conducted the onsite IT CSV/GMP audits, conducted daily closeout meetings with client, and prepared and delivered the audit reports to our client.
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