SOLABS Blog

Ensuring the production and delivery of high quality products is an ongoing issue in the pharmaceutical and medical device manufacturing settings. In order to comply with scrutiny from regulatory agencies as well as consumer expectations, manufacturers in the life sciences industry have established systematic methods to ensure the quality of their manufacturing processes.  An organizations internal quality management system has evolved from a targeted effort to manage individual processes to a recognized need to implement a ‘holistic’ solution that includes management of controlled documents (SOPs, Test Methods, Specifications, etc……), management of Quality Processes (CAPA, Change Control, Complaints, Deviations, etc…..) and Management of Employee Training Records.  The quandary that many life science organizations face is the decision to maintain these Qa processes in a paper-based system, a partially automated system or to implement a fully automated eQMS.

There are a number of persuasive arguments in favor of life science organizations pursuing automation with regard to management of its quality processes…….

• Impact of an eQMS on an organization’s ‘Overall Cost of Quality’-

The ‘Overall Cost of Quality’ that a manufacturer faces can be defined as follows:

“The sum of all costs associated with poor quality or product failure, including rework and costs incurred in preventing or resolving quality problems”.

With regard to Life Sciences organizations, we can add diminished brand equity, increased scrutiny from regulatory agencies, the potential for receipt of an FDA warning letter as well as hefty fines.  Most Qa leaders agree that an eQMS system allows organizations to manage their Qa processes with more control and more consistency than they would have using manual, paper-based Qa systems.  An automated system minimizes the intrusion of human error in the organizations Qa processes resulting in an improvement in its operational efficiency.  That added efficiency can be expected to help reduce instances of “poor quality and/or product failure” yielding a positive impact on the organization’s overall cost of quality. 

• Consistent regulatory compliance-(21 CFR, part 11)

Practically speaking, ‘21 CFR, Part 11’ requires drug makers, medical device manufacturers, biotech companies, biologics developers, CROs, and other FDA-regulated industries to implement controls including audits, system validations, audit trails, electronic signatures, and documentation for software and systems.   In order for the "hard copy" produced from an organization’s internal systems to be considered as the authoritative document, the "hard copy" must be a complete and accurate copy of its electronic source and it must be used exclusively for regulated activities.  The stipulation that the FDA places on submission of “hard copy” documents leaves some level of vagueness and interpretation.  An eQMS solution with integrated e-signature functionality goes a long way towards ensuring that an organization is compliant with the demands of regulatory agencies…..consistently. 

·         Audit ‘Readiness’ -electronic audit trail.

“One of the ways we can expect the FDA to tighten its oversight of the industry is to increase the frequency of audits at Pharma and med device companies, to make certain that manufacturers’ operations are in compliance with all associated regulatory requirements. Although audits are nothing new to many in the industry, the anticipated uptick in these audits as the agency finds new and more efficient ways to perform them will likely catch many companies off guard. This will include a spike in the number of on-site audits performed with little prior notice and may also extend to include remote audits in which companies will submit data electronically”……Tim Mohn, Lifescienceleader.com

The Qa group in any Life Sciences organization works very hard to protect its employer from being the target of FDA audits…….unfortunately, an audit is sometimes unavoidable.  An eQMS allows an organization to respond to an FDA audit more efficiently and more effectively because it will include an ‘electronic audit trail’ that can be generated in minutes rather than hours (or days).