Asset Regulatory and Compliance Management (ARCM):
The FDA is displaying heightened interest in maintenance and asset management compliance during inspections, All GMP facilities should be subject to a maintenance program. The pharmaceutical industry is challenged by a regulatory environment that is increasingly demanding and stringently enforced. As a result, companies are struggling to achieve and maintain an ongoing state of compliance and consequently, the ability to supply products to the market.
At Markrl Inc., we have expertise of Good Manufacturing Practices (GMP) to achieve for our clients a successful business goals with high quality. Reduce headaches and expenses related to compliance by coordinating calibration and maintenance compliance program.
We offer different services that related to Quality and compliance maintenance engineering program like:
· Training Work Instruction “TWI”
· Standard Operating Procedures “SOP”
· Corrective Action Preventive Action “CAPA”
· Like for Like “LFL” assessment
· Change Management “CM”
· Audit “ADT”