Companies in the Life science, Chemical and Food business, have to mandatorily comply with various regulatory norms related to product, manufacturing, environment & procurement processes and adhere to Corporate Governance.

Life Sciences companies must deal with a wide range of industry-specific regulatory issues, in addition to, standard corporate governance, risk management and statutory compliance demands. In fact, regulatory compliance is a core part of the business, ensuring a competitive supply chain, promoting customer confidence, and enabling profitability and growth.

Chemicals Manufacturing Organizations must deal in Environmental, Health, and Safety (EH&S). The mandates are numerous and complex. Companies must minimize EH&S risks by ensuring legal compliance and supporting corporate sustainability policies – with a focus on cost and resource containment.

Some of the Guidelines that the life science company should follow specific to Electronic Records and Signatures are

• EU Directive 91/356 (EU GMP Guideline) – This directive specifies legal requirements for good manufacturing practice (GMP) in the European Union (EU). It requires that data be available at the proper time, provided in a readable form, and protected against damage or loss
• ICH Q7A Guideline – International Conference on Harmonization (ICH) Q7A provides guidelines for active pharmaceutical ingredients in the EU, the United States, and Japan
• PIC/S – The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) provide guidance on pharmaceutical inspections
• CFR 21 part 11 – This U.S. FDA regulation establishes requirements for electronic records systems, regulating the use of computer systems, audit trails, lot and serial traceability, change control, archiving, e-signatures, and security

Some of the issues that Chemical or Drug Manufacturing companies have comply are both Regional and Global environmental regulations including Workers’ Health and Safety Programs.

SpectraSoft can help you

- Life Sciences Industry

• Validation of Applications, Data center
  
• Preparation of protocols
  
• Guide and Re validate as and when Regulation or Process parameter changes

- Chemical, Food & Beverages Industry

Incorporation and implementation of Policies across Business processes that address challenges such as

• Lowering risks by staying current with ever-changing regulations and trends
  
• Reducing costs of achieving and managing EH&S
  
• Managing EH&S more effectively with timely information to make corrective actions