While quality control is essential for any manufacturing company, it is a life and death issue for manufacturers of medical devices. Heavy regulatory requirements force these companies to comply with ; standards for safety, effectiveness, identity, strength and quality.  Consistency in quality control processes and visibility into complaints and adverse events are critical. Since the burden is on the manufacturer to prove conformity, they must document and implement stringent procedures and effective event tracking processes in order to supply information on demand as required to the FDA (US Food and Drug Administration) and other regulatory bodies.

While medical device manufacturers have long embraced CRM (Customer Relationship Management) software,  they primarily use the software for sales and marketing management. Only recently have many medical device manufacturers discovered  that they can leverage CRM to enhance quality control procedures, service and event tracking, business process automation, and critical data collection and reporting.

In order for a CRM solution to be instrumental in achieving these ends, however, it must be compliant with the following.

Electronic Signatures

A fairly new statement to FDA-regulated medical device manufacturing companies concerns Section 21 Part 11 of the Code of Federal Regulations. The code establishes the standards by which the Food and Drug Administration will accept electronic records and electronic signatures as equivalent to paper records and handwritten signatures. The rule governs electronic records throughout their lifecycle from creation through modification, storage, and final transmission to the FDA.

The creation of this regulation and the FDA's encouragement of the use of electronic records and signatures have placed a significant burden on the developers and users of data collection, management, reporting, and analysis software in regulated industries.

Three imperative components of electronic signature compliance are the positive identification of the person, the security precautions taken to ensure  integrity and the reduction of paper

Document Controls

According to FDA's publication in 21 CFR 820.40,manufacturers are required to have documented procedures for the approval and distribution of documents. The approval procedures must assure the documents meet the requirements of the QS/GMP as well as adequacy for their intended use. Obsolete documents must be removed from circulation. Documentation of procedures (manufacturing, design, quality control, laboratory, etc.) need to include an authorized signature, electronic or wet, and must be dated as approved. Such documentation must be available at the point at which they are to be used or otherwise needed. Document change records must include a description of the change, identification of the affected documents, an appropriate approval signature, approval date and effective date of the change.

Identification and Traceability According to FDA's publication in 21 CFR 820.60, manufacturers are required to have documented procedures for identifying products during all stages of receipt, production, distribution, and installation. For certain devices intended for surgical implant into the body, or to support or to sustain life and whose failure, when properly used in accordance with labeled instructions for use, can be reasonably expected to result in a significant injury to the user, the manufacturer must have written procedures for identifying each unit, lot or batch of finished device or where appropriate, components with a control number. The procedure should facilitate taking corrective action.

Traceability need only go the level of the initial consignee, which is the first person(s) outside of the manufacturer's control. This control number would be used to facilitate complaint investigations, recall, market withdrawals, market corrections, etc.

The traceability requirement should not be confused with the tracking regulation under FDA's 21 CFR 821.The tracking regulation requires certain devices to be tracked to the end user or patient through the entire distribution process.

Process Validation

According to FDA's publication in 21 CFR 820.75, manufacturers must make the determination as to whether the firm's processes are or may be contributing to defective devices. There are several ways of making this assessment. For example, process validation information should be reviewed to identify defect characteristics and rate of expected defects of each characteristic for the finished product. Single Point of Contact

The FDA demands that the customers of medical device manufacturers have a single point of contact for any service or product related questions and issues. Critical information must be accurate  and easily obtained and communicated by the single point of contact. A knowledge base that includes technical documentation must be easily accessed and kept up to date according to standards set forth  in the FDA's publication in 21 CFR 820.40.

Not all CRM solutions offer the essential functionality to cater to medical device manufacturing  needs. However, medical device manufacturers seeking  to leverage CRM to comply with FDA regulations  need to look beyond standard CRM sales, marketing and service  offerings to more robust and specific functionality. A CRM solution should facilitate these issues with integrated electronic signature functionality for approvals and the relevant supporting audit trail. This is important for document control in a central CRM knowledge base, adverse effect and event routing approvals within a service-related module  and other core regulated business processes. Security and auditing precautions must be taken into account and supported. A central electronic document library  for product, technical and clinical support is essential to provide consistent, accurate information and to reduce paper usage. The ability to record end-user clinical  application specific data in custom fields and forms is crucial. Product tracking by both serial and lot numbers is critical for service trend analysis, product traceability and tracking. The software should be able to manage support contracts and product  warranties. The CRM Prescription

Today, there are many choices in CRM technologies. Most offer strengths in traditional areas such as sales and service, while others go beyond the norm to offer a suitable prescription to remedy the stringent requirements placed on medical device manufacturing industry by the FDA. In most cases, CRM software is designed to do much more than help pass the "FDA test." Aside from the software's ability to reduce the painstaking process of generating complex reports it can help improve market penetration, promote clear communication  with customers and vendors, assist in maintaining quality control and, of course, help retain customers by improving your service responsiveness, company-wide knowledge and reliability.