Did you know that the FDA regulates data integrity? Pharmaceutical and Medical Device industries must operate in accordance with current Good Manufacturing Practices (cGMP) for regulatory industries, such as the FDA and MHRA, to deem a product as safe for consumers. Although the focus of cGMP is often in the material production of the product, the data generated in the testing and tracking of a product also falls under regulatory scrutiny. Some would say that the data and company records are the crux of regulatory inspections.
What is Data Integrity?
According to the FDA, “data integrity refers to the completeness, consistency, and accuracy of data”. Requirements for GMP-compliant data include:
- Data are exact and complete, secure from alteration, accidental erasures or loss. This extends to backup data.
- Documentation is generated at the time of performance. In other words, data cannot be initially transcribed on scrap paper then transferred into a lab notebook.
- Laboratory controls are “scientifically sound” and complete. Complete means all the information derived from all tests. For example, a spectral report must contain the entire read-out and each complete read-out is stored.
- Electronic signatures and record-keeping are compliant with 21 CFR part 11 regulations.
Electronic Quality Management Systems (eQMS)
Besides testing and tracking of production, your users, audit documentation, training documentation, and blank forms are regulated under GMP guidance. Since the complete data generated in pharmaceutical and medical device manufacturing is extensive, most companies rely on electronic records. It is possible to use a combination of various documentation software, tracking spreadsheets, paper documents, emails, and chat programs for data management. However, this is inefficient for auditing and often ineffective. An FDA inspector will scrutinize the time it takes to retrieve complete documentation during an audit. The general rule of thumb is to fulfill an audit request in fifteen minutes or less. Frequently, successful companies use an electronic quality management system (eQMS) to manage the data and documentation generated in pharmaceutical and medical device manufacturing.
PSC Software® is a trusted, industry-leading, cloud-native provider of quality management software with specialization in meeting the needs of pharmaceutical, medical device, and other highly regulated industries. The Adaptive Compliance Engine (ACE®) eQMS is a single platform eQMS that is highly configurable to your company’s quality and manufacturing
ACE® is absolutely the most configurable EMS platform you will find. It is the type of system that becomes your most trusted system of use and record; and which is a force multiplier for efficiency, speed of information, knowledge preservation, document management, SOP development, and countless other activities particular to your industry.”
Data Migration into an eQMS
At home or in non-regulated businesses environment, getting a new phone or computer is simple and transferring data is only a small headache. Data migration while following GMP regulations requires significantly more testing, sampling, and verifications. We will go through the process of data migration in the case of using PSC Software®.
Pitfall #1: Maintaining GMP compliance during migration.
Solution: Utilize consultants trained in data migration for GMP regulated industries.
PSC Software® provides a data migration service with trained professionals in computerized systems compliance. A data migration is a joint effort between the client and PSC Software®. PSC Software® develops the migration plan, workflow, templates, and protocol. The data comes from you.
Pitfall #2: Poor data quality.
Solution: Perform a gap analysis ahead of time. Make source data quality a priority.
Missing records, duplicates, misspellings, erroneous data, incomplete data and records may exist within a multi-platform quality management system. Perform a gap analysis before migrating your data. The old adage, “Bad Data In = Bad Data Out,” applies to data migration too. PSC Biotech® has consultants experienced in gap analysis for regulatory compliance.
If the import data is not formatted correctly, extra time and resources will need to be spent on “scrubbing” the data. In worst case scenarios, the data import itself will have to be re-executed. Spending time on data quality pre-migration is more efficient than hastily importing data.
Pitfall #3: Deficient documentation of the migration process.
Solution: Develop a migration plan, workflow, templates, and protocol ahead of time.
Avoid failing regulatory guidelines by developing a migration plan, workflow, templates, and protocol ahead of time. PSC Software® professionals provide these services when assisting with data migration. In the planning stage, you can check that data will remain complete, consistent, and accurate while maintaining records according to the ALOCA principle:
- Attributable – the who, what, when, where, and why
- Contemporaneously recorded
- Original or a true copy
Pitfall #4: Lack of communication and collaboration.
Solution: Define responsibilities, involve concerned parties, and understand the process.
The following is an example of the division of responsibilities in a successful data migration for pharmaceutical and medical device manufacturing.
PSC Software® Responsibilities
- Authoring of migration plan and protocol
- Record metadata matrix
- Provide data import template(s)
- Test import and check for data errors
- Migrate into production
- Sample records to verify successful import
- Provide data migration summary report
- Review and approve migration plan and protocol
- Provide pre-scrubbed data in approved import templates
- Correct any data issues
- Provide access to data for migration
- Review and approve data migration summary report
PSC Software® Solutions
Using an electronic quality management system avoids many pitfalls of quality assurance and regulatory compliance. Data migration is easier with professionals. Ensure your data integrity and regulatory compliance when switching to ACE® with PSC Software® professional assistance.
Contact us to find out more!
PSC Software Solutions
PSC Biotech Services provide fast, budget-friendly, high-level expertise.
Share, Engage, Stay Current
As the life science industries continue to evolve, the emphasis on regulation, safety, and efficiency is more pronounced than ever. Verifying a company has and follows standard operational procedures (SOPs) addressing each category using the tried-and-true methods of...
This interactive carousel offers a concise and engaging exploration of PSC Biotech's CSV (Computer System Validation) services. CSV is a critical component mandated by the FDA to ensure the accuracy, reliability, and consistency of computer systems used in the life...
The timeline of the 21 CFR Part 11 (Code of Federal Regulations) marks a significant evolution in regulatory standards within the United States. The Significance Today The 21 CFR reflects an ongoing commitment to ensuring the safety, quality, and efficacy of products...