“What is not documented, never happened,” says Björn Aalbers, Co-founder and Co-owner of Rescop. Anything that could conceivably affect a pharmaceutical product’s purity, potency, or safety is subject to increasing scrutiny from regulatory agencies. “Every activity that could impact product integrity needs to be documented as per FDA regulations. This leads to a considerable amount of paper work that needs to be generated by companies and must be easily retrievable.”
Regulatory burden is a brake on agility in the Health and Life Sciences space, but it is also literally burdensome. The volume of documentation required isn’t easy to store, manipulate, or produce on demand. “During a regulatory audit,” Aalbers explains, “companies will create ‘war rooms’ of several employees whose only function is to retrieve documentation as it is requested by the auditor and ensure nothing is missing.” This makes the audit a situation of acute stress, with considerable stakes at play for both employees and management.
Our system is proactive and will inform the user before a non-compliance situation arises
Rescop is in the best possible place to solve this problem. Their position, as both consultants and software developers, brings in the best ideas of each industry; the most current best field practices implemented in software, software/IT solutions for the biggest headaches in the field. “Companies and CIOs, using our software systems, are getting the most updated and proven practices in the Health and Life Sciences industry,” he says. Rescop's compliance solutions are international in scope, enabled by a multi-cultural, globally-distributed team of experts.
Rescop's quality management software, for example, lets a company manage all compliance and quality management documentation within a central application— one that is aware of the regulatory environment.
Furthermore, contract manufacturing organizations can use Rescop’s Logbook software, for example, to manage all equipment maintenance and calibration requirements. Necessary tasks are scheduled, completion monitored, and all required compliance documentation generated within a single application. At the other end of the organizational chart, corporate directors can use Validation Lifecycle Management software to execute global roll outs of IT systems while nearly eliminating the administrative overhead of international regulatory compliance.
Facilitating their clients’ work on the international state is the Rescop Academy, a spectrum of training courses offered all around the world. “During regulatory audits,” Aalbers notes, “ documented evidence must be available that personnel are qualified for the roles that they are performing.” Rescop instructors are contractors in the field, which is another case of Rescop's ability to leverage competencies across divisions.
Training is also recommended for senior management, as they have unique responsibilities related to compliance, quality management, and the auditing process.
As Rescop pushes forward with product development, they've realized improvements in user experience and deeper integration into the Health and Life Sciences tool path. This reinforces their position as a credible regulatory compliance solution provider to companies of all sizes, though their ideal customers are small and innovative. These newer, nimbler companies “must invest heavily in R&D and are facing the same regulatory challenges as larger companies,” Aalbers observes, so they benefit the most from the reduced administrative costs and compliance solutions Rescop delivers.