A Real Practical Business Solution

We were retained by a client to assess its computer systems development, validation and data management processes for regulatory compliance (e.g., 21 CFR part 11, 21 CFR part 312). The extensive review (six working days) revealed multiple issues relating to SOPs, training, validation and data management activities. The issues were symptomatic of two basic business problems: company operations were effective (the systems and processes work properly for the most part) but not efficient and the Quality Assurance function was not effective. The risk here is that the company may start loosing business: potential clients may not become new clients and existing clients may become former clients.

The client had two choices: to expand compliance to reflect the current policy and SOP requirements and address the gaps or to assess the existing operations and streamline them as much as possible. We recommended the latter.

Option number 1 would provide a quick fix but would result in having to increase the number of people within certain departments and potential timeline delays (proper documentation generation and maintenance is time consuming). On the other hand, streamlining the operations would:

1. Create an infrastructure that can support the company’s growth.
2. Be less costly to maintain over time.
3. Ensure minimal delays.
4. Simplify training for the new employees.
5. Create a working environment that is easier to comply with due to significantly less documentation and fewer requirements.

Accepting and acting upon option 2 allowed our client to create a manageable documentation suite, become and remain compliant with their internal procedures and capitalize on the capabilities of the existing personnel. And all this was accomplished without having to increase staff but rather by maximizing on the resources and expertise the company already had in place.

This is but one of our examples of how practical business solutions are developed in that murky area where regulatory compliance, operations and business risk meet.