Antrix, Inc ANTRIX, Inc
Regulatory Affairs & Quality Assurance Consulting Services for
Medical Device and Medicinal Drugs
O 408 733 1199
F 408 730 5959

Document Control and Records Management in Regulated Environments

1. Service Description

This service provides customized tailored implementation of the document control and records management system and tools to comply with the regulatory environment in the United States and European Union (EU) for management of standard operating documents and the subsequent management of the resulting paper and electronic records.

There will be productivity increase and cost savings of more than 90% using our service. Your company will save money from several thousand to millions of dollars adding to your bottom line profit.

It is designed to provide you with robust system for managing a document control or records department in a manufacturing company.  Document control is an essential element of an effective quality system. Documents demonstrate that the systems and controls used to ensure that finished devices meet specification have been effectively implemented. They communicate desired outcomes, clarify methods, and ensure consistent results. The service takes into account of the national and international laws and their impact on the lifecycle of documents from use in the ISO/FDA manufacturing environment to records retention and disposition. When implemented properly, document controls help reduce the likelihood of defects and minimize field problems. Ultimately, these improvements increase customer satisfaction.

2. Cost Savings - Return on Investments (ROI)

Amount of money saved by your company on using our service based on the company size is provided in the Table 1.0.

Projected savings is based on

  1. Process efficiency gains (people)
  2. Less personnel requirements (people)
  3. Infrastructure efficiency gains (systems)
  4. Infrastructure validation and maintenance (systems)
  5. Delivering quality products
  6. Avoid regulatory noncompliance cost
  7. Avoid regulatory fines cost

Compared to cost associated with company's inefficient internal manual methods, , systems, tools, software’s, and personnel etc. Detailed Return on Investment (ROI) information is available on request.

Company Size Small Medium Large
$Savings > 90 % > 90 % > 90 %
Annual Sales < $100 million $100 million < Sales < $500 million > $500 million
Number of Submissions <= 2 per year 2 < Sub <= 4 per year > 4 per year

Table 1.0 - Amount of money saved by your company on using our service. Company size is based on annual sales as per FDA classification.

3. Solution Approach

The approach consists of:

  1. Identification and documentation of industry and applicable regulations and standards organization needs to comply
  2. Implementation of records management standard operating procedure
  3. Implementation of change order related standard operating procedure
  4. Identification and implementation of various quality tools such as 5S as it applies to document control and records management.
  5. Identification and implementation of archival practices and how that differs from records retention.
  6. Identification and implementation of current security and privacy laws and the effect on the controls inherent to document control and records retention.
  7. Identification of Quality records, Device History Record (DHR), Device Master Record (DMR) and Drug Master File (DMF)
  8. Gap analysis of how the FDA and EMEA see document control and records management from an auditing standpoint and some audit tips

Example ISO 9001 QMS Documentation - A typical documentation structure and example of documents to control.Example ISO 9001 QMS Documentation - A typical documentation structure and example of documents to control.

Figure 1 - Example ISO 9001 QMS Documentation - A typical documentation structure and example of documents to control.

4. Definitions

Quality Record: A record which provides objective evidence of the conformance of products and systems to specifications and process requirements defined by the quality system.

Device History Record (DHR): A compilation of records containing the complete production history of a finished device.

Device Master Record (DMR): A compilation of documents containing a device's complete formulation and the quality system requirements including procedures and specifications for manufacturing, packaging, labeling, servicing maintenance and installation.

Lifetime of Product – time that a device is expected to remain functional after is placed into use.

Title 21 CFR Part 11 - Control of Records

(b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency.

(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.

(k) Use of appropriate controls over systems documentation including: (1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance. (2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation.

5. Applicable Laws, Regulations and Standards

  1. Title 21 CFR 11, Electronic Records and Electronic Signatures
  2. Title 21 CFR 210 cGMP Manufacturing
  3. Title 21 CFR 211 cGMP Finished Pharmaceuticals
  4. Title 21 CFR 820 Quality System Regulation (Devices)
  5. ICH Guidelines Q7A cGMP for Active Pharmaceutical Ingredients
  6. ISO 9000 family of standards
  7. ISO 13485 Quality Management System (Medical Devices)
  8. ISO 17799 Information Security
  9. Title 21 CFR Part 820.180, 820.181, 820.184, 820.186 & 820.198
  10. ISO 13485 section 4.2