case study

Speeding Up Document Change Control

A leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their document change process.

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.

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Speeding Up Document Change Control

Background

Qualitest, a leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their document control process. Document changes were taking an average of 50 to 60 days to complete. The company sought a compliant process with faster turn-around times.

RCA’s wealth of knowledge about our document management system & document control helped us speed up our process, halving the turn-around time.

 

Solution

Qualitest engaged Regulatory Compliance Associates® Inc. to improve the document change process. RCA quickly dove in to understand the document management software and current process to identify issues and areas for improvement. Together with Qualitest, RCA revised standard operating procedures to reflect the new process and embark on training with both users and management to pilot the new SOPs.

 

Result

The pilot of the new document change process was effective. The document version control also generated new feedback for further improvement by the client’s internal team. Qualitest incorporated the pilot feedback and rolled out the new process & document control system. Today at Qualitest, on average, document change takes place in less than 30 days and, in many cases, even faster.

 

About RCA

document controlRegulatory Compliance Associates® (RCA) provides worldwide 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

Qualitest, a leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their document control process. Document changes were taking an average of 50 to 60 days to complete. The company sought a compliant process with faster turn-around times.

RCA’s wealth of knowledge about our document management system & document control helped us speed up our process, halving the turn-around time.

 

Solution

Qualitest engaged Regulatory Compliance Associates® Inc. to improve the document change process. RCA quickly dove in to understand the document management software and current process to identify issues and areas for improvement. Together with Qualitest, RCA revised standard operating procedures to reflect the new process and embark on training with both users and management to pilot the new SOPs.

 

Result

The pilot of the new document change process was effective. The document version control also generated new feedback for further improvement by the client’s internal team. Qualitest incorporated the pilot feedback and rolled out the new process & document control system. Today at Qualitest, on average, document change takes place in less than 30 days and, in many cases, even faster.

 

About RCA

document controlRegulatory Compliance Associates® (RCA) provides worldwide 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. 

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