case study

Gap Analysis for Electronic Records

RCA was contracted to perform a gap assessment of eight quality software systems and 29 laboratory software systems. After reviewing remediation plans, the FDA chose not to make a regulatory observation.

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

Please complete the form to access the case study.

*=Required

Gap Analysis for Electronic Records

Background

In preparing for an upcoming audit by the FDA, a pharmaceutical chemical manufacturer required a gap analysis. The goal of the chemical products company was to determine compliance of quality and laboratory software to requirements for electronic records (21 CFR Part 11).

 

Challenge

RCA was contracted to perform a gap analysis for software systems used by chemical suppliers. Eight quality management system (QMS system) and twenty-nine lab software systems were analyzed in the chemical factories based in USA.

 

Approach

Regulatory Compliance Associates® Inc. developed a gap assessment strategy based on each unique chemical manufacturing plant. Client interviews were conducted based on specialty chemical manufacturing and each software system. A gap testing questionnaire was used with each level of manufacturing team member. 

Answers were reached to determine compliance with chemical manufacturing industry standards and specific requirements of Part 11. Then a risk assessment was performed to determine highest risk software systems based on compliance with Part 11.

Finally the gap analysis process prioritized each of the software systems based on the risk analysis. This prioritization was used to develop a data gap analysis and remediation plan to bring all software into compliance.

 

Result

The final gap analysis document results was presented to the chemical supplier company. It contained a detailed SWOT analysis and software gap analysis to prioritize work needed for the remediation plan. Each production facility had an individual remediation action plan and recommendations to reach regulatory compliance. 

Within a month of the gap assessment, the FDA revisited the client’s corporate headquarters. The Food and Drug Administration reviewed the findings and remediation plans. The FDA determined the client demonstrated a regulatory pathway to eliminate the non compliance. No additional regulatory observation was given and the FDA approved the client was in compliance with 21 CFR Part 11. 

 

About RCA

life science consultantsRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing.

We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Background

In preparing for an upcoming audit by the FDA, a pharmaceutical chemical manufacturer required a gap analysis. The goal of the chemical products company was to determine compliance of quality and laboratory software to requirements for electronic records (21 CFR Part 11).

 

Challenge

RCA was contracted to perform a gap analysis for software systems used by chemical suppliers. Eight quality management system (QMS system) and twenty-nine lab software systems were analyzed in the chemical factories based in USA.

 

Approach

Regulatory Compliance Associates® Inc. developed a gap assessment strategy based on each unique chemical manufacturing plant. Client interviews were conducted based on specialty chemical manufacturing and each software system. A gap testing questionnaire was used with each level of manufacturing team member. 

Answers were reached to determine compliance with chemical manufacturing industry standards and specific requirements of Part 11. Then a risk assessment was performed to determine highest risk software systems based on compliance with Part 11.

Finally the gap analysis process prioritized each of the software systems based on the risk analysis. This prioritization was used to develop a data gap analysis and remediation plan to bring all software into compliance.

 

Result

The final gap analysis document results was presented to the chemical supplier company. It contained a detailed SWOT analysis and software gap analysis to prioritize work needed for the remediation plan. Each production facility had an individual remediation action plan and recommendations to reach regulatory compliance. 

Within a month of the gap assessment, the FDA revisited the client’s corporate headquarters. The Food and Drug Administration reviewed the findings and remediation plans. The FDA determined the client demonstrated a regulatory pathway to eliminate the non compliance. No additional regulatory observation was given and the FDA approved the client was in compliance with 21 CFR Part 11. 

 

About RCA

life science consultantsRegulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing.

We are used to working on the front lines and thriving in the scrutiny of FDA-and globally-regulated companies. As your partners, we can negotiate the potential minefield of regulatory compliance and private equity due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

To begin the RCA® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Our website uses cookies to give you the best possible experience.

By continuing to use this site, you agree to the use of cookies.
Continue