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 around document change control helped us speed up our process, halving turn-around time.

Solution

Qualitest engaged Regulatory Compliance Associates® Inc. to improve the document change process. RCA quickly dove in to understand the current process, identify issues and outline 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 and generated some feedback for further improvement. Qualitest incorporated the pilot feedback and rolled out the new process. Today at Qualitest, on average, document change takes place in less than 30 days and, in many cases, even faster.

About RCA

Outsourcing strategic management can provide a better match to changing QA / RA strategic needs through a company’s lifecycle. RCA’s interim management brings needed expertise while saving costs.

We can provide needed expertise while saving costs in areas including:

  • Quality
  • Regulatory
  • Operations
  • Medical Affairs
  • Product Development

Additional Quality services include:

  • Medical Device Single Audit Program (MDSAP) Readiness Audit
  • Document Control Systems Implementation and Remediation
  • Quality System Implementation
  • Quality System Remediation
  • Risk Management (ISO 14971)
  • ISO 13485:2016
  • 21 CFR part 820
  • Quality Due Diligence
  • Laboratory Support
    • Standard Operating Procedure (SOP) Development
    • Method Transfer
    • Method Validation

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 around document change control helped us speed up our process, halving turn-around time.

Solution

Qualitest engaged Regulatory Compliance Associates® Inc. to improve the document change process. RCA quickly dove in to understand the current process, identify issues and outline 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 and generated some feedback for further improvement. Qualitest incorporated the pilot feedback and rolled out the new process. Today at Qualitest, on average, document change takes place in less than 30 days and, in many cases, even faster.

About RCA

Outsourcing strategic management can provide a better match to changing QA / RA strategic needs through a company’s lifecycle. RCA’s interim management brings needed expertise while saving costs.

We can provide needed expertise while saving costs in areas including:

  • Quality
  • Regulatory
  • Operations
  • Medical Affairs
  • Product Development

Additional Quality services include:

  • Medical Device Single Audit Program (MDSAP) Readiness Audit
  • Document Control Systems Implementation and Remediation
  • Quality System Implementation
  • Quality System Remediation
  • Risk Management (ISO 14971)
  • ISO 13485:2016
  • 21 CFR part 820
  • Quality Due Diligence
  • Laboratory Support
    • Standard Operating Procedure (SOP) Development
    • Method Transfer
    • Method Validation

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